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Completed

NCT Number: NCT03322774

Sleep To Reduce Incident Depression Effectively

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.

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Key information

Conditions

Insomnia, Primary Depressive Disorder Depressive Disorder, Major Digestive System Diseases Dyssomnias Feeding and Eating Disorders Gastrointestinal Diseases Major Depressive Disorder Mental Disorders Mood Disorders Nervous System Diseases Rumination Rumination Syndrome Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

digital cognitive behavioral therapy for insomnia

Behavioral

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

face-to-face Cognitive Behavioral Therapy for Insomnia

Behavioral

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 names: CBT-I

Sleep Hygiene Education Control

Behavioral

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.

Primary outcomes

  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. Antidepressant history in the past 1 year is collected via online-administered surveys 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Big Health Inc.
  • University of Michigan

Registry information

Acronym: STRIDE

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 26, 2017
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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