Clinical trial NCT03322774: Sleep To Reduce Incident Depression Effectively
Official title: Sleep To Reduce Incident Depression Effectively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia, Primary
Major Depressive Disorder
Rumination
Keywords: Stepped Care
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Big Health Inc.
name: University of Michigan
First posted: 2017-10-26
Enrollment: 1237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
timeFrame: 1 and 2 years after initial randomization.
measure: Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Secondary outcomes:
measure: Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Mediation of Depression Prevention by Reducing Rumination (Worry)
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia.
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment.
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment.
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
measure: Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters.
timeFrame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Medical Center - Columbus
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Christopher L Drake, PhD
role: PRINCIPAL_INVESTIGATOR
References: