Sleep to Prevent Evolving Affecting Disorders

Study Overview
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Brief Summary
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The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.

Detailed Description
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The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia. Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly sessions which each take up to 20 minutes to complete. A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.

Official Title
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Sleep to Prevent Evolving Affecting Disorders

Conditions
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Insomnia, Primary, Depression

Intervention / Treatment
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* Behavioral: dCBTI
* Behavioral: Sleep Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia Exclusion Criteria: Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCBTI<br>Online access to the digital CBTI program Sleepio | Behavioral: dCBTI<br> <br> |
| Placebo Comparator: Sleep Education<br>Weekly email messages with sleep hygiene recommendations | Behavioral: Sleep Education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Depression | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression | Pre-treatment (Day 1) | 
| Prevention of Incident Depression (Post-treatment) | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) | Post-treatment ( 6 week after Screening) | 
| Prevention of Depression Relapse 1-years Post Treatment | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) | 1-year follow-up (58 week after screening) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Symptoms of Insomnia - Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | Post-treatment ( 6 week after Screening) | 
| Severity of Symptoms of Insomnia - 1 year Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | 1-year follow-up (58 week after screening) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, depression, digital CBTI, online CBTI