Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep To Reduce Incident Depression Effectively (STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03322774
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
Big Health
University of Michigan
Information provided by (Responsible Party):
Christopher Drake, 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.

Condition or disease Intervention/treatment Phase
Insomnia, Primary Major Depressive Disorder Rumination Behavioral: digital Cognitive Behavioral Therapy for Insomnia Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia Behavioral: Sleep Hygiene Education Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Sleep To Reduce Incident Depression Effectively
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Attention 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.
Behavioral: Sleep Hygiene Education Control
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.

Experimental: Stepped Care Model
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.
Behavioral: digital Cognitive Behavioral Therapy for Insomnia
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.
Other Names:
  • Sleepio
  • dCBT-I

Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia
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.
Other Name: CBT-I

Sham Comparator: Stepped Care Model 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.
Behavioral: digital Cognitive Behavioral Therapy for Insomnia
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.
Other Names:
  • Sleepio
  • dCBT-I

Behavioral: Sleep Hygiene Education Control
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.

Experimental: digital CBT-I
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.
Behavioral: digital Cognitive Behavioral Therapy for Insomnia
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.
Other Names:
  • Sleepio
  • dCBT-I




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. Mediation of Depression Prevention by Reducing Rumination (Depressive rumination) [ Time Frame: 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.

  2. Mediation of Depression Prevention by Reducing Rumination (Worry) [ Time Frame: 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.

  3. Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic) [ Time Frame: 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.

  4. Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia. [ Time Frame: 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.

  5. Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment. [ Time Frame: 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.

  6. Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment. [ Time Frame: 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.

  7. Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Determination of Insomnia (ISI > 14)
  • No DSM-5 major depressive disorder at baseline (per SCID-5 interview).
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322774


Contacts
Layout table for location contacts
Contact: Cynthia Fellman-Couture, PhD 248-344-7362 cfellma1@hfhs.org
Contact: Andrea Cuamatzi, BS 2483447363 acuamat1@hfhs.org

Locations
Layout table for location information
United States, Michigan
Henry Ford Medical Center - Columbus Recruiting
Novi, Michigan, United States, 48377
Contact: Cynthia Fellman-Couture, PhD    248-344-7362    cfellma1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Big Health
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Christopher L Drake, PhD Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by Christopher Drake, Henry Ford Health System:
Study Protocol  [PDF] November 1, 2017

Layout table for additonal information
Responsible Party: Christopher Drake, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03322774    
Other Study ID Numbers: IRB 11586
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Drake, Henry Ford Health System:
Stepped Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases