Sleep To Reduce Incident Depression Effectively
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia, Primary
- Sponsor
- Henry Ford Health System
- Enrollment
- 1237
- Locations
- 1
- Primary Endpoint
- Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.
Detailed Description
This project will assess the acute and long-term effectiveness of dCBT-I on Research Domain Criteria (RDoC) sleep parameters: Insomnia Severity Index (ISI), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low SES, minority). This will be tested by administering internet-based dCBT-I to people with insomnia and adding face-to-face CBT-I in non-remitters, as well as comparing the RDoC sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. This study will also determine the acute and long-term effectiveness of face-to-face CBT-I in non-responders to dCBT-I on RDoC sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups. This study will also determine the effects of dCBT-I and CBT-I using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. Specifically, rate of depression of both dCBT-I and CBT-I will be compared to a control group. This study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.
Investigators
Christopher Drake
Principal Investigator
Henry Ford Health System
Eligibility Criteria
Inclusion Criteria
- •Determination of Insomnia (ISI \> 14)
- •And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology \< 11)
Exclusion Criteria
- •Age \< 18
- •Current use of antidepressants for depression
- •Bipolar or Seizure disorders
- •Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
- •Current DSM-5 major depressive disorder at baseline.
Outcomes
Primary Outcomes
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
Time Frame: 1 and 2 years after initial randomization.
Clinical interview by phone administered by trained personnel to determine DSM-5 major depressive disorder incidence and relapse. Major depressive disorder will specifically be determined by the structured clinical interview for DSM-5 (SCID-5) at 1- and 2-year follow-ups. Antidepressant history in the past 1 year is collected via online-administered surveys at 1- and 2-year follow-ups.
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Time Frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Insomnia remission rates based on the Insomnia Severity Index. Total score range 0-28 with higher scores meaning more insomnia. Remission = ISI \< 8.
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
Time Frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Rumination as measured by the Pre-Sleep Arousal Scale, Cognitive factor. Scores range from 8 to 40 with higher scores indicating more rumination. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Secondary Outcomes
- Mediation of Depression Prevention by Reducing Rumination (Worry)(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment.(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia.(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment.(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)
- Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters.(Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.)