Sleep To Reduce Incident Depression Effectively (STRIDE)

• ClinicalTrials.gov Identifier: NCT03322774
• Recruitment Status: Recruiting
• First Posted: October 26, 2017
• Last Update Posted: March 19, 2020
• Sponsor: Henry Ford Health System
• Collaborators: Big Health; University of Michigan
• Information provided by (Responsible Party): Christopher Drake, Henry Ford Health System

Tracking Information

• First Submitted Date: October 16, 2017
• First Posted Date: October 26, 2017
• Last Update Posted Date: March 19, 2020
• Actual Study Start Date: March 9, 2018
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2019)

• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: October 23, 2017)

Prevention of Incident Depression and Depression Relapse 2-years Post Treatment [ Time Frame: 2-year follow up (120 weeks after screening) ]

Rate of Incidence of depression determined by score on the Quick Inventory of Depressive Symptomatology (QIDS; if total score > 12, possible range 0-27, with higher scores meaning greater severity) and confirmed by Structured Clinical Interview for DSM-5 (SCIDS)

Current Secondary Outcome Measures (submitted: June 17, 2019)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: October 23, 2017)

• Mediation of Prevention of Depression by Ruminating Behavior - Post Treatment [ Time Frame: 16 weeks after screening ]
  Rumination as determined by Thought Control Questionnaire for Insomnia - Revised (TCQI-R; total score range 35-151, with higher scores meaning more rumination)
• Mediation of Prevention of Depression by Ruminating Behavior - 1 year Post Treatment [ Time Frame: 1-year follow-up (68 weeks after screening) ]
  Rumination as determined by Thought Control Questionnaire for Insomnia - Revised (TCQI-R; total score range 35-151, with higher scores meaning more rumination)
• Mediation of Prevention of Depression by Ruminating Behavior - 2 years Post Treatment [ Time Frame: 2-year follow up (120 weeks after screening) ]
  Rumination as determined by Thought Control Questionnaire for Insomnia - Revised (TCQI-R; total score range 35-151, with higher scores meaning more rumination)
• Moderating Effect of Depression Risk-Factors in Effectiveness of Treatment - Post Treatment [ Time Frame: 16 weeks after screening ]
  Race, SES, Sleep Reactivity (Ford Insomnia Response to Stress Test, FIRST; total score range 0-27, with higher scores meaning greater reactivity) as moderating effect upon Research Domain Criteria (RDoC) outcomes (Sleep Onset Latency, Wake After Sleep Onset)
• Moderating Effect of Depression Risk-Factors in Effectiveness of Treatment - 1 year Post Treatment [ Time Frame: 1-year follow up (68 weeks after screening) ]
  Race, SES, Sleep Reactivity (Ford Insomnia Response to Stress Test, FIRST; total score range 0-27, with higher scores meaning greater reactivity) as moderating effect upon Research Domain Criteria (RDoC) outcomes (Sleep Onset Latency, Wake After Sleep Onset)
• Moderating Effect of Depression Risk-Factors in Effectiveness of Treatment - 2 years Post Treatment [ Time Frame: 2-year follow up (120 weeks after screening) ]
  Race, SES, Sleep Reactivity (Ford Insomnia Response to Stress Test, FIRST; total score range 0-27, with higher scores meaning greater reactivity) as moderating effect upon Research Domain Criteria (RDoC) outcomes (Sleep Onset Latency, Wake After Sleep Onset)
• Severity of Symptoms of Insomnia - Post Treatment [ Time Frame: 16 weeks after screening ]
  Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
• Severity of Symptoms of Insomnia - 1 year Post Treatment [ Time Frame: 1-year follow-up (68 weeks after screening) ]
  Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
• Severity of Symptoms of Insomnia - 2 years Post Treatment [ Time Frame: 2-year follow-up (120 weeks after screening) ]
  Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
• Prevention of Incident Depression and Depression Relapse Post-Treatment [ Time Frame: 16 weeks after screening ]
  Rate of Incidence of depression determined by score on the Quick Inventory of Depressive Symptomatology (QIDS; if total score > 12, possible range 0-27, with higher scores meaning greater severity) and confirmed by Structured Clinical Interview for DSM-5 (SCIDS)
• Prevention of Incident Depression and Depression Relapse 1-year Post Treatment [ Time Frame: 1-year follow up (68 weeks after screening) ]
  Rate of Incidence of depression determined by score on the Quick Inventory of Depressive Symptomatology (QIDS; if total score > 12; possible range 0-27, with higher scores meaning greater severity) and confirmed by Structured Clinical Interview for DSM-5 (SCIDS)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sleep To Reduce Incident Depression Effectively
• Official Title: Sleep To Reduce Incident Depression Effectively
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Single (Participant); Primary Purpose: Prevention

Condition

• Insomnia, Primary
• Major Depressive Disorder
• Rumination

Intervention

• 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
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Sleep Hygiene Education Control
• 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.
  Interventions:

  • Behavioral: digital Cognitive Behavioral Therapy for Insomnia
  • Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia
• 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.
  Interventions:

  • Behavioral: digital Cognitive Behavioral Therapy for Insomnia
  • Behavioral: Sleep Hygiene Education Control
• 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.
  Intervention: Behavioral: digital Cognitive Behavioral Therapy for Insomnia

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 17, 2019): 1000
• Original Estimated Enrollment (submitted: October 23, 2017): 500
• Estimated Study Completion Date: April 30, 2023
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Cynthia Fellman-Couture, PhD; 248-344-7362; cfellma1@hfhs.org

Contact: Andrea Cuamatzi, BS; 2483447363; acuamat1@hfhs.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03322774
• Other Study ID Numbers: IRB 11586
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Christopher Drake, Henry Ford Health System
• Study Sponsor: Henry Ford Health System

Collaborators

• Big Health
• University of Michigan

Investigators

• Principal Investigator: Christopher L Drake, PhD; Henry Ford Health System

• PRS Account: Henry Ford Health System
• Verification Date: March 2020