Sleep To Reduce Incident Depression Effectively
STRIDE
1 other identifier
interventional
1,237
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedStudy Start
First participant enrolled
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedOctober 1, 2024
September 1, 2024
5.1 years
October 16, 2017
September 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
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.
1 and 2 years after initial randomization.
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Insomnia remission rates based on the Insomnia Severity Index. Total score range 0-28 with higher scores meaning more insomnia. Remission = ISI \< 8.
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
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.
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Secondary Outcomes (7)
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
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 (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.
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.
- +2 more secondary outcomes
Study Arms (4)
Attention Control
SHAM COMPARATORThis 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
EXPERIMENTALThis 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 Control
SHAM COMPARATORThis 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
EXPERIMENTALThis 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.
Interventions
Cognitive Behavioral Therapy for Insomnia administered online through the "Sleepio" program. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long online video sessions with an animated figure called "The Prof," which delivers the treatment.
Cognitive Behavioral Therapy for Insomnia administered by experienced staff trained in behavioral sleep medicine. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long face-to-face sessions with an experienced staff member trained in behavioral sleep medicine.
Participants are provided with information about good sleep hygiene through 6 weekly emails. Participants practice good sleep hygiene as part of their sleep routine. In Step 1, sleep hygiene control will be exclusively online. In Step 2, sleep hygiene control includes an in-person, face-to-face component.
Eligibility Criteria
You may qualify if:
- Determination of Insomnia (ISI \> 14)
- And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology \< 11)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- Big Health Inc.collaborator
- University of Michigancollaborator
Study Sites (1)
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377, United States
Related Publications (1)
Drake CL, Kalmbach DA, Cheng P, Ahmedani BK, Peterson EL, Joseph CLM, Roth T, Kidwell KM, Sagong C. Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression. Trials. 2022 Dec 1;23(1):967. doi: 10.1186/s13063-022-06850-4.
PMID: 36457045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher L Drake, PhD
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 26, 2017
Study Start
March 9, 2018
Primary Completion
April 30, 2023
Study Completion
June 27, 2024
Last Updated
October 1, 2024
Record last verified: 2024-09