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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT-I | Experimental | Digitally-delivered CBT for insomnia accessed via web and/or mobile app |
|
| Sleep hygiene education | Active Comparator | This group will receive access to sleep hygiene education delivered via digital written materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital CBT-I | Device | A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Insomnia Severity Index (ISI) | Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity | From baseline to 10 weeks post-randomization |
| Change in sleep onset latency (SOL) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to 10 weeks post-randomization |
| Change in wake after sleep onset (WASO) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to 10 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI | Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity | 10, 16, and 24 weeks post-randomization |
| Insomnia disorder remission based on the SCID Insomnia Module |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41343796 | Derived | Prather AA, Krystal AD, Emsley R, Carl J, Ball T, Tarnai K, Aguilera A, Espie CA, Henry AL. The Effectiveness of Digital Cognitive Behavioral Therapy to Treat Insomnia Disorder in US Adults: Nationwide Decentralized Randomized Controlled Trial. JMIR Ment Health. 2025 Dec 4;12:e84323. doi: 10.2196/84323. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep hygiene education | Other | Participants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish. |
|
structured interview to assess for Insomnia Disorder |
| Week -1 compared to weeks 10, 16, and 24 post-randomization |
| Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT) | Each measured in minutes by daily sleep diaries (based on the Consensus Sleep Diary) | From lead-in period to 10, 16, and 24 weeks post-randomization |
| Change in the Sleep Condition Indicator (SCI-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep | From baseline to weeks 10, 16, and 24 post-randomization |
| Change in the Generalized Anxiety Disorder Questionnaire (GAD-7) | Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity | From baseline to weeks 10, 16, and 24 post-randomization |
| Change in the Patient Health Questionnaire (PHQ-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity | From baseline to weeks 10, 16 and 24 post-randomization |
| Change in the Insomnia Severity Index (ISI) | Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity | From baseline to weeks 16 and 24 post-randomization |
| Change in sleep onset latency (SOL) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to weeks 16 and 24 post-randomization |
| Change in wake after sleep onset (WASO) | Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days | From baseline to weeks 16 and 24 post-randomization |
| D001523 |
| Mental Disorders |