Sleep To Reduce Incident Depression Effectively

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Rumination; Insomnia, Primary
• Interventions: Behavioral: digital Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygiene Education Control; Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT03322774
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Study Start: 2018-03-09
• Primary Completion: 2023-04-30
• Study Completion: 2024-06-27
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1237

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stepped Care Model Control	Sleep Hygiene Education Control	This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will receive sleep hygiene education, serving as a credible control intervention for comparison to the Stepped Care Model.
Attention Control	Sleep Hygiene Education Control	This group receives sleep hygiene education, which serves as a credible control intervention to digital cognitive behavioral therapy for insomnia (dCBT-I). This intervention mimics the web-based patient contact inherent in dCBT-I but is inert with respect to sleep outcomes.
Stepped Care Model Control	digital Cognitive Behavioral Therapy for Insomnia	This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will receive sleep hygiene education, serving as a credible control intervention for comparison to the Stepped Care Model.
digital CBT-I	digital Cognitive Behavioral Therapy for Insomnia	This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Treatment includes weekly sessions of CBT-I administered over the internet in hour-long video sessions. Daily sleep diaries are recorded online for individual tailoring of treatment.
Stepped Care Model	face-to-face Cognitive Behavioral Therapy for Insomnia	This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will begin treatment with face-to-face Cognitive Behavioral Therapy for Insomnia with a trained staff member in behavioral sleep medicine.
Stepped Care Model	digital Cognitive Behavioral Therapy for Insomnia	This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will begin treatment with face-to-face Cognitive Behavioral Therapy for Insomnia with a trained staff member in behavioral sleep medicine.

Primary Outcome Measures

Name	Time	Method
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.	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.	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)	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 Outcome Measures

Name	Time	Method
Mediation of Depression Prevention by Reducing Rumination (Worry)	Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.	Rumination as determined by the Penn State Worry Questionnaire. Scores range from 16-80 with higher scores indicating greater worry. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)	Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.	Rumination as determined by the Rumination Response Scale. Scores range from 22-88 with higher scores indicating higher depressive rumination. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
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.	Low socioeconomic status will be defined as annual household income \< $20,000. Stepped care treatment will be less effective for preventing depression for patients in poverty as compared to patients above the the poverty line.
Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)	Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.	Rumination as determined by the Perseverative Thinking Questionnaire. Scores range from 15-75 with higher scores indicating greater perseverative thinking. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
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.	Depressive symptoms as measured by the Quick Inventory of Depressive Sympatomatology, 16 item self report version. Reductions in depressive symptoms will be operationalized as (1) pre to posttreatment changes, (2) pretreatment to 1-year follow-up changes, and (3) pretreatment to 2-year follow-up changes.
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.	Race will be self reported by patients. Stepped care treatment will be less effective for preventing depression for patients who self-identify as racial minorities (e.g., non-Hispanic black) relative to non-Hispanic white patients.
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.	Sleep parameters as captured by self-reported sleep onset latency, wake after sleep onset, and sleep efficiency.

Trial Locations

Locations (1)

Henry Ford Medical Center - Columbus; 🇺🇸 Novi, Michigan, United States