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| Name | Class |
|---|---|
| RAND | OTHER |
| Palo Alto Veterans Institute for Research | OTHER |
| University of Missouri-Columbia | OTHER |
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The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Insomnia Coach Mobile App Intervention | Experimental | Participants assigned to the experimental condition are asked to view the modules within the app for 8 weeks. The mobile app contains content based on cognitive behavioral therapy for insomnia (CBT-I) enhanced with content from brief alcohol interventions. |
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| Sleep Hygiene Control | Active Comparator | Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Insomnia Coach | Behavioral | The intervention combines the Insomnia Coach app with additional brief alcohol intervention to facilitate behavior change for both drinking behavior and insomnia symptoms. Insomnia Coach contains multiple components of CBT-I (e.g., stimulus control, cognitive restructuring, relaxation training, sleep hygiene/psychoeducation, monitoring of sleep via journals). The brief alcohol intervention content added to the CBT-I app is based on CBT skills for moderate drinking, delivered in a motivational enhancement style, and has demonstrated efficacy among young adults and veterans (e.g., correcting perceived norms, use of protective behavioral strategies, challenging expectancies). |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia symptoms | 7-item Insomnia Severity Index (ISI). The ISI is a measure of insomnia symptoms including difficulty falling/staying asleep, sleep problems interfering with daily life, and concern about sleep problems. | Past 30 days |
| Alcohol use frequency | Days used in past 30 days | Past 30 days |
| Alcohol use quantity | Number of drinks per drinking occasion | Past 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | The 19-item Pittsburgh Sleep Quality Index will assess nuanced sleep behaviors at each time point (e.g., sleep latency, sleep duration, subjective sleep quality) | Past 30 days |
| Alcohol-related consequences |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment initiation | Affirmative responses regarding whether participants initiated more formal treatment since starting the study | Past 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Pedersen | Contact | (323) 442-4046 | Eric.Pedersen@med.usc.edu |
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Data will be shared in accordance with NIH guidelines and uploaded to the NDA repository.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants are asked to complete one of two mobile phone-based programs. They may not know which condition is the experimental condition and which is the control.
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| Sleep hygiene comparator | Behavioral | Content is based on sleep hygiene practices, but without additional CBT-I content featured in the experimental condition. There is also not brief alcohol intervention content in the control condition. |
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15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.
| Past 30 days |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |