Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-06 @ 7:07 PM
Study NCT ID:
NCT03364192
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2017-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peer-Delivered Whole Health Coaching for Veterans With PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Emily.Johnson1@va.gov', 'phone': '315-425-4400', 'title': 'Emily M. Johnson, Ph.D., PI', 'phoneExt': '53487', 'organization': 'VA Center for Integrated Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-Serious Adverse Event-Unrelated to Study Participation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Goal Attainment Scaling (GAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.'}], 'classes': [{'title': 'Baseline Phase', 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Peer-Delivered Whole Health Coaching Phase', 'categories': [{'measurements': [{'value': '4.15', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance/Follow-up Phase', 'categories': [{'measurements': [{'value': '4.63', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Multilevel Modeling', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.', 'description': "Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were included in this analysis if they initiated peer-delivered Whole Health Coaching within 2 weeks of their designated start date, if they met the baseline stability criterion (at least four data points on the primary outcome, the final two of which had to fall within the range of the previous two data points, for at least 5 of the 9 domains), and if they completed at least three assessments during the intervention phase.'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist for DSM-5 (PCL-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.4', 'spread': '4.40', 'groupId': 'OG000'}]}]}, {'title': 'Before Peer-Delivered Whole Health Coaching', 'categories': [{'measurements': [{'value': '53.5', 'spread': '4.40', 'groupId': 'OG000'}]}]}, {'title': 'After Peer-Delivered Whole Health Coaching', 'categories': [{'measurements': [{'value': '49.22', 'spread': '4.67', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up (24 weeks)', 'categories': [{'measurements': [{'value': '49.61', 'spread': '4.67', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.', 'description': "The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants included in the primary analysis are analyzed here.'}, {'type': 'SECONDARY', 'title': 'Inventory of Psychosocial Functioning (IPF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38.74', 'spread': '4.54', 'groupId': 'OG000'}]}]}, {'title': 'Before Peer-Delivered Whole Health Coaching', 'categories': [{'measurements': [{'value': '30.49', 'spread': '4.54', 'groupId': 'OG000'}]}]}, {'title': 'After Peer-Delivered Whole Health Coaching', 'categories': [{'measurements': [{'value': '28.24', 'spread': '4.77', 'groupId': 'OG000'}]}]}, {'title': 'Follow-Up (24 weeks)', 'categories': [{'measurements': [{'value': '28.59', 'spread': '4.77', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.', 'description': 'The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants meeting criteria for inclusion in the primary analysis are included here.'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.18', 'spread': '4.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks following intervention onset', 'description': "Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CSQ-8 was analyzed for all participants with non-missing data at this timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.71', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline information is only available for eligible participants (n = 18). Baseline data is missing for one participant who withdrew following randomization prior to completion of the baseline measures resulting in a sample size of n = 17.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 558636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-30T13:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive peer-delivered Whole Health Coaching but the start date will be randomized between 4 and 13 weeks from initiation of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2017-11-30', 'resultsFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-23', 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goal Attainment Scaling (GAS)', 'timeFrame': 'Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.', 'description': "Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains."}], 'secondaryOutcomes': [{'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.', 'description': "The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes."}, {'measure': 'Inventory of Psychosocial Functioning (IPF)', 'timeFrame': 'Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.', 'description': 'The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes.'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': '8 weeks following intervention onset', 'description': "Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whole Health Coaching', 'Integrative Health Coaching', 'Peer Support Specialist', 'Personalized Health Plan'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.\n\nWhole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.\n\nAll participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.', 'detailedDescription': 'The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.\n\nWhole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.\n\nAll participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran status\n* Enrolled in primary care at the Syracuse VA (and affiliated CBOCs) and seen in primary care within the past year\n* Probable PTSD defined as screening positive for a Criterion A event and PTSD Checklist for DSM-5 (PCL-5) score 33\n\nExclusion Criteria:\n\n* Unable to communicate in spoken and written English\n* Gross cognitive impairment\n* Current symptoms of mania/psychosis\n* At risk for suicide\n* Engaged in psychotherapy in a non-primary care setting\n* Changes to psychotropic medications for PTSD within the last 2 months\n* Preference for direct referral to specialty mental healthcare'}, 'identificationModule': {'nctId': 'NCT03364192', 'briefTitle': 'Peer-Delivered Whole Health Coaching for Veterans With PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans With PTSD', 'orgStudyIdInfo': {'id': 'D2476-M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-delivered Whole Health Coaching', 'description': 'Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it will be administered by a peer support specialist.', 'interventionNames': ['Behavioral: Whole Health Coaching']}], 'interventions': [{'name': 'Whole Health Coaching', 'type': 'BEHAVIORAL', 'description': 'Veterans Health Administration variation of integrative health coaching.', 'armGroupLabels': ['Peer-delivered Whole Health Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse VA Medical Center, Syracuse, NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Emily Johnson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse VA Medical Center, Syracuse, NY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}