Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-30 @ 1:36 PM
Study NCT ID:
NCT03431493
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2018-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aparke36@jhu.edu', 'phone': '443-287-2616', 'title': 'Ann Parker, MD, PhD', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until completion of end of intervention surveys or study drop out (4 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility Measure Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.', 'unitOfMeasure': 'proportion of intended visits', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group only'}, {'type': 'PRIMARY', 'title': 'Total Feasibility Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'units': 'visits', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study', 'unitOfMeasure': 'proportion of total intervention visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'visits', 'denomUnitsSelected': 'visits', 'populationDescription': 'Participants in the intervention group only'}, {'type': 'PRIMARY', 'title': 'Feasibility Measure/Assess Loss to Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000'}, {'value': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Average number of patients enrolled per month over 12 weeks', 'unitOfMeasure': 'average participants per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'An instrument used to assess anxiety symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) - Depression Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'An instrument used to assess depressive symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Personal Health Questionnaire - 8 Item Version (PHQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms. Higher score more symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '61.4', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The AMPAC-CAT, a measure of physical function, has 269 items across three domains (basic mobility, daily activity and applied cognitive). The computer adaptive test requires a mean of 22 items from the item bank. Scores are norm-based (min 0 and mx 100). Higher scores indicate better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L - Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The EQ-5D-5L is an instrument developed by the EuroQol group to measure health status. The Eq-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, ranging from 1 (no problems) to 5 (extreme problems). The resulting health utility score ranges from -0.11 to 1.00. Higher scores indicate better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Healthcare Utilization - Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of patients with inpatient readmissions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with data collected'}, {'type': 'SECONDARY', 'title': 'Healthcare Utilization - Ever Utilized Mental Health Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of participants who ever utilized outpatient mental health', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'patients with data collected'}, {'type': 'SECONDARY', 'title': 'Healthcare Utilization - Rehabilitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of patients who ever utilized physical rehabilitation services', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'patients with data collected'}, {'type': 'SECONDARY', 'title': 'Behavioral Activation for Depression SCALE (BAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '104.0', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a 25-item scale that measures changes in avoidance and activation over the course of Behavioral Activation treatment using a 7 point scale (0=not at all to 6=completely). The scale is grouped into 4 subscales (Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment). To calculate a total score, items on all subscales other than Activation are reverse-coded and then an unweighted sum is computed. Score range 0 to 150. Higher scores indicate greater activation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Connor-Davidson Resilience Scale (CD RISC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a 25-item scale with each item rated on a 5-point scale (higher scores indicating greater resilience). The total score ranges from 0 to 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of adherence', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to COVID-19 pandemic-related changes for research staff such that fewer staff were available for research procedures, and needed to decrease burden on staff for data collection to allow for prioritizing key data elements (including primary outcomes).'}, {'type': 'SECONDARY', 'title': 'Percentage of Sessions Fully Completed and Partially Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of adherence for intervention group', 'unitOfMeasure': 'percentage of sessions completed', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is for intervention group only'}, {'type': 'SECONDARY', 'title': 'Montreal Cognitive Assessment (MoCA) - BLIND', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Impact of Events Scale - Revised (IES-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a measure the subjective response to a specific traumatic event (in this case - critical illness and associated ICU experience). The IES-R consists of 22 items, each rated on a 5-point scale; item scores are averaged to generate a mean total score (range: 0-4). Higher score indicates more stress symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected'}, {'type': 'SECONDARY', 'title': 'Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A clinical interview to assess depressive symptoms. This is a qualitative assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to participant survey burden and COVID-19 pandemic-related changes for both research staff and participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'FG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation\n\nBehavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.'}, {'id': 'BG001', 'title': 'Usual Care Control', 'description': 'Usual Care Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-05', 'size': 624435, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-18T14:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2018-02-06', 'resultsFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Measure Per Participant', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.'}, {'measure': 'Total Feasibility Measure', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study'}, {'measure': 'Feasibility Measure/Assess Loss to Follow-up', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.'}, {'measure': 'Feasibility Measure', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Average number of patients enrolled per month over 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'An instrument used to assess anxiety symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) - Depression Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'An instrument used to assess depressive symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).'}, {'measure': 'Personal Health Questionnaire - 8 Item Version (PHQ-8)', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms. Higher score more symptoms.'}, {'measure': 'Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The AMPAC-CAT, a measure of physical function, has 269 items across three domains (basic mobility, daily activity and applied cognitive). The computer adaptive test requires a mean of 22 items from the item bank. Scores are norm-based (min 0 and mx 100). Higher scores indicate better function.'}, {'measure': 'EQ-5D-5L - Utility Score', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'The EQ-5D-5L is an instrument developed by the EuroQol group to measure health status. The Eq-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, ranging from 1 (no problems) to 5 (extreme problems). The resulting health utility score ranges from -0.11 to 1.00. Higher scores indicate better health status.'}, {'measure': 'Healthcare Utilization - Readmissions', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of patients with inpatient readmissions'}, {'measure': 'Healthcare Utilization - Ever Utilized Mental Health Care', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of participants who ever utilized outpatient mental health'}, {'measure': 'Healthcare Utilization - Rehabilitation', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'Patient interview to assess the following end of study (ie \\~12 weeks) variable: number of patients who ever utilized physical rehabilitation services'}, {'measure': 'Behavioral Activation for Depression SCALE (BAS)', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a 25-item scale that measures changes in avoidance and activation over the course of Behavioral Activation treatment using a 7 point scale (0=not at all to 6=completely). The scale is grouped into 4 subscales (Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment). To calculate a total score, items on all subscales other than Activation are reverse-coded and then an unweighted sum is computed. Score range 0 to 150. Higher scores indicate greater activation.'}, {'measure': 'Connor-Davidson Resilience Scale (CD RISC)', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a 25-item scale with each item rated on a 5-point scale (higher scores indicating greater resilience). The total score ranges from 0 to 100.'}, {'measure': 'Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of adherence'}, {'measure': 'Percentage of Sessions Fully Completed and Partially Completed', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of adherence for intervention group'}, {'measure': 'Montreal Cognitive Assessment (MoCA) - BLIND', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.'}, {'measure': 'Impact of Events Scale - Revised (IES-R)', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'This is a measure the subjective response to a specific traumatic event (in this case - critical illness and associated ICU experience). The IES-R consists of 22 items, each rated on a 5-point scale; item scores are averaged to generate a mean total score (range: 0-4). Higher score indicates more stress symptoms.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale', 'timeFrame': 'end of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.'}, {'measure': 'Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)', 'timeFrame': 'End of intervention (12 weeks)', 'description': 'A clinical interview to assess depressive symptoms. This is a qualitative assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency', 'Depression', 'Rehabilitation', 'Critical Care']}, 'descriptionModule': {'briefSummary': 'More and more people are surviving after receiving life support for respiratory failure in the intensive care unit, but these patients often experience problems with depression and physical functioning that lead to reduced quality of life. There is a lack of treatment for these patients, with past research suggesting that treatment may be more successful if mental and physical health are addressed at the same time. This research evaluates whether a therapy delivered via telephone and home visits, combining treatment for depression and physical rehabilitation, is feasible and might help patients recover.', 'detailedDescription': 'A growing number of Acute Respiratory Failure (ARF) survivors are burdened by depressive symptoms and physical impairments that last for years after intensive care unit discharge. Notably, depressive symptoms are independently associated with subsequent development of new impairments in physical functioning. There is a lack of treatment options to address these impairments in ARF survivors, with past research suggesting combining treatment for mental and physical health might be more successful.\n\nTherefore, this study is designed to evaluate:\n\n1. The feasibility (primary outcome) of participant recruitment and retention in a pilot randomized controlled trial (RCT) of an intervention combining Behavioral Activation (an evidence-based psychological treatment for depression) and physical rehabilitation delivered via telephone and 2 home visits over 12-weeks versus a "usual care" control group.\n2. The efficacy (secondary outcome) of this Behavioral Activation-Rehabilitation intervention to reduce depressive symptoms and improve physical functioning.\n3. Modifiable psychosocial risk factors for depressive symptoms in ARF survivors and the association between the intervention and these modifiable factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Living at home before the current admission (not in a facility)\n* Acute respiratory failure managed in the ICU \\> 24hrs (≥1 of the following):\n\n 1. Mechanical ventilation via an endotracheal tube or tracheostomy \\> 12hrs (and not ventilator-dependent before admission) OR\n 2. Non-invasive ventilation (CPAP, BiPAP) \\> 4 hours in a 24 hour period provided for acute respiratory failure (not for Obstructive Sleep Apnoea (OSA) or other stable use) OR\n 3. High flow nasal cannula with Fraction of Inspired Oxygen (FiO2) ≥ 0.5 for ≥4 hours in a 24hr period\n* At least mild depressive symptoms (score ≥2 on PHQ-2 scale)\n\nExclusion Criteria:\n\n* Pre-existing cognitive impairment (based on review of medical records, or proxy- administered Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score \\>3.3)\n* Declines informed consent or not capable of providing informed consent\n* Non-English speaking\n* Homelessness or living \\>50 miles away from study site\n* Bedbound prior to the current admission\n* Expected survival \\< 6 months according to ICU attending\n* ICU Length Of Stay (LOS) \\> 30 days\n* Not discharged home from the hospital\n* Complex medical care expected soon after discharge (e.g. multiple planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, chemotherapy or radiation therapy, etc)\n* Active substance abuse or psychosis\n* Lack of access to telephone or inability to use telephone independently\n* Pregnancy\n* Suicidality\n* Incarcerated'}, 'identificationModule': {'nctId': 'NCT03431493', 'acronym': 'BEHAB', 'briefTitle': 'Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors', 'orgStudyIdInfo': {'id': 'IRB00143231'}, 'secondaryIdInfos': [{'id': 'K23HL138206', 'link': 'https://reporter.nih.gov/quickSearch/K23HL138206', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation - Rehabilitation', 'description': 'Behavioral Activation - Rehabilitation', 'interventionNames': ['Behavioral: Behavioral Activation - Rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Control', 'description': 'Usual Care Control'}], 'interventions': [{'name': 'Behavioral Activation - Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant\'s exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week\'s goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant\'s progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.', 'armGroupLabels': ['Behavioral Activation - Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ann M Parker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}