Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 9:18 AM
Study NCT ID:
NCT05016960
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sleep-SMART for Veterans With MCI and Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erin.almklov@va.gov', 'phone': '858-552-8585', 'title': 'Dr. Erin Almklov', 'phoneExt': '3907', 'organization': 'VA San Diego Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Deaths, serious adverse events, and non-serious adverse events were not assessed for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sleep-SMART', 'description': 'Sleep-SMART intervention\n\nSleep-SMART: Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment components along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire (CSQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.43', 'spread': '2.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'PRIMARY', 'title': 'Telehealth Usability Questionnaire (TUQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.92', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Measure (AIM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'PRIMARY', 'title': 'Intervention Appropriateness Measure (IAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.41', 'spread': '.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Post treatment', 'categories': [{'measurements': [{'value': '63.79', 'spread': '16.192', 'groupId': 'OG000'}]}]}, {'title': 'Pre treatment', 'categories': [{'measurements': [{'value': '62.50', 'spread': '17.105', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.503', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test to compare scores at pre vs. post treatment'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre treatment', 'categories': [{'measurements': [{'value': '24.86', 'spread': '8.047', 'groupId': 'OG000'}]}]}, {'title': 'Post treatment', 'categories': [{'measurements': [{'value': '26.57', 'spread': '5.734', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.230', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Everyday Cognition Scale (ECoG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Post treatment', 'categories': [{'measurements': [{'value': '83.71', 'spread': '30.19', 'groupId': 'OG000'}]}]}, {'title': 'Pre Treatment', 'categories': [{'measurements': [{'value': '89.86', 'spread': '34.576', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.061', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': "Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insomnia Severity Index (ISI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '19.40', 'spread': '4.95', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '8.87', 'spread': '6.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '11.69', 'spread': '5.10', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '8.85', 'spread': '3.16', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '22.79', 'spread': '6.841', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '22.21', 'spread': '6.739', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.625', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '14.33', 'spread': '5.454', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '16.00', 'spread': '5.074', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.134', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '146.63', 'spread': '46.745', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '140.13', 'spread': '54.038', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.515', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test and range from \\<3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 8 participants as 8 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '12.25', 'spread': '2.417', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '11.75', 'spread': '1.712', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.410', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to \\>21, with higher scores indicating better performance.', 'unitOfMeasure': 'words generated', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 12 participants as 4 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '6.93', 'spread': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '7.14', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.706', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.', 'unitOfMeasure': 'words recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '5.44', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '6.56', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.062', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.', 'unitOfMeasure': 'correctly recalled elements', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '22.00', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '21.0', 'spread': '2.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.390', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.', 'unitOfMeasure': 'words recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '53.11', 'spread': '17.43', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '47.33', 'spread': '25.96', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.38', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'one group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '65.22', 'spread': '32.82', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '46.44', 'spread': '15.75', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.064', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'One group paired samples t test'}], 'paramType': 'MEAN', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 - Sleep-SMART Development', 'description': 'Phase 1 involved conducting a focus group with Veterans from the target population to inform development of the Sleep-SMART intervention and manual.'}, {'id': 'FG001', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Phase 2 involved piloting the Sleep-SMART treatment that was developed in Phase 1. Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Veterans aged 60 or older with MCI and insomnia were recruited from VA San Diego health clinics between 12/07/2021 and 12/31/2023.', 'preAssignmentDetails': 'Enrolled participants were excluded from the treatment phase (phase 2) if they did not meet study eligibility criteria at pre-treatment assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 2 - Sleep-SMART Treatment', 'description': 'Participants in Phase 2 received the Sleep-SMART treatment intervention and were administered baseline measures. Baseline and outcome measures were not collected as part of Phase 1.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data was analyzed for treatment completers (n=16).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data was analyzed for treatment completers (n=16).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data was analyzed for treatment completers (n=16).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data was analyzed for treatment completers (n=16).'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insomnia Severity Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.40', 'spread': '4.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-28 with higher scores indicating more severe insomnia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was analyzed for treatment completers (n=16)'}], 'populationDescription': 'Baseline and outcome data was not collected from Phase 1 participants as they did not participate in the SleepSMART treatment. Phase 1 participants completed a one time focus group interview which was conducted to help guide the development of the SleepSMART treatment protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-21', 'size': 376325, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-03T15:05', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 90495, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-03T15:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The investigators will develop and pilot test a modified CBT-I treatment that incorporates technology, user-centered design principles, and CogSMART strategies to improve sleep and rehabilitation outcomes for Veterans with co-occurring insomnia and MCI. The investigators will assess the feasibility and acceptability of Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), which will seamlessly incorporate select CogSMART cognitive strategies within a standard 6-session 50-minute CBT-I treatment protocol. Sleep-SMART will focus on enhancing CBT-I by providing supportive cognitive strategies designed to boost treatment learning and adherence.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-08-13', 'resultsFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-03', 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.'}, {'measure': 'Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.'}, {'measure': 'Everyday Cognition Scale (ECoG)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': "Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning."}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.'}, {'measure': 'Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.'}, {'measure': 'Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.'}, {'measure': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test and range from \\<3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.'}, {'measure': 'Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to \\>21, with higher scores indicating better performance.'}, {'measure': 'Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.'}, {'measure': 'Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.'}, {'measure': 'Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.'}, {'measure': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.'}, {'measure': 'Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)', 'timeFrame': 'At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.'}], 'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.'}, {'measure': 'Telehealth Usability Questionnaire (TUQ)', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': 'At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.', 'description': 'Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Mild Cognitive Impairment', 'Veterans', 'Behavioral Sleep treatment', 'CBT for Insomnia', 'CogSMART', 'Feasibility', 'Acceptability'], 'conditions': ['Insomnia', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.', 'detailedDescription': 'Mild cognitive impairment (MCI) is an important public health concern for aging Veterans due to the increased risk for progression to dementia and increased mortality. Insomnia is common in MCI (occurring in up to 60% of patients) and increases risk for dementia, disability, and poor quality of life. Rates of MCI and insomnia are higher among Veterans than civilians, thus aging Veterans with MCI and comorbid insomnia represent a particularly high-risk population. The gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a multi-component behavioral intervention. However, cognitive impairments experienced by individuals with MCI may limit the rate of progress in CBT-I. The use of memory support strategies can improve patient recall of therapeutic information, enhance treatment adherence, and improve treatment outcomes. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) provides compensatory strategies to improve learning, memory, attention, and executive functioning. CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive impairment. Incorporating supportive CogSMART cognitive strategies into CBT-I has the potential to improve treatment learning, adherence, and outcomes for this Veteran population. This RR\\&D SPiRE research project will assist us in developing and evaluating Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an innovative user-informed approach for treatment of insomnia in Veterans with MCI. Sleep-SMART is intended to provide the core components of CBT-I along with training in compensatory cognitive strategies from CogSMART to enhance intervention adherence and learning. Provision of this supportive cognitive training will assist Veterans with cognitive impairments in maintaining compliance with the CBT-I regimen, thereby leading to faster and more complete treatment benefits. The principle aims for the investigation include: 1) developing the Sleep-SMART intervention and treatment manual; 2) assessing the feasibility and acceptability of Sleep-SMART in Veterans with MCI and insomnia; and 3) exploring the effects of Sleep-SMART on rehabilitation outcomes, quality of life, sleep, and cognitive functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans ages 60 or older who are competent to provide informed consent\n* Chart diagnosis of MCI based on previously published criteria\n* DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score \\>7 at baseline\n* Ability to understand, speak, and read English with acceptable visual and auditory acuity\n\nExclusion Criteria:\n\n* Sleep disorders other than insomnia as determined by medical chart review and clinical interview\n* History of a neurological disorder, dementia, or moderate to severe TBI\n* Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments\n* Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder\n* Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale'}, 'identificationModule': {'nctId': 'NCT05016960', 'acronym': 'Sleep-SMART', 'briefTitle': 'Sleep-SMART for Veterans With MCI and Insomnia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study', 'orgStudyIdInfo': {'id': 'D3721-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep-SMART', 'description': 'Sleep-SMART intervention', 'interventionNames': ['Behavioral: Sleep-SMART']}], 'interventions': [{'name': 'Sleep-SMART', 'type': 'BEHAVIORAL', 'description': 'Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.', 'armGroupLabels': ['Sleep-SMART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161-0002', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Erin Almklov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}