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Sleep To Reduce Incident Depression Effectively (STRIDE)

Primary Purpose

Insomnia, Primary, Major Depressive Disorder, Rumination

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
digital Cognitive Behavioral Therapy for Insomnia
face-to-face Cognitive Behavioral Therapy for Insomnia
Sleep Hygiene Education Control
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia, Primary focused on measuring Stepped Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford Medical Center - Columbus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Sham Comparator

Experimental

Arm Label

Attention Control

Stepped Care Model

Stepped Care Model Control

digital CBT-I

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
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)
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)
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.
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.
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.
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.
Sleep parameters as captured by self-reported sleep onset latency, wake after sleep onset, and sleep efficiency.

Full Information

First Posted
October 16, 2017
Last Updated
July 19, 2023
Sponsor
Henry Ford Health System
Collaborators
Big Health Inc., University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03322774
Brief Title
Sleep To Reduce Incident Depression Effectively
Acronym
STRIDE
Official Title
Sleep To Reduce Incident Depression Effectively
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
March 9, 2024 (Anticipated)
Study Completion Date
March 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Big Health Inc., University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Primary, Major Depressive Disorder, Rumination
Keywords
Stepped Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Stepped Care Model
Arm Type
Experimental
Arm Description
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.
Arm Title
Stepped Care Model Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
digital CBT-I
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
digital Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
Sleepio, dCBT-I
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
face-to-face Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education Control
Intervention Description
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 Outcome Measure Information:
Title
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
Description
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.
Time Frame
1 and 2 years after initial randomization.
Title
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Description
Insomnia remission rates based on the Insomnia Severity Index. Total score range 0-28 with higher scores meaning more insomnia. Remission = ISI < 8.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Secondary Outcome Measure Information:
Title
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Mediation of Depression Prevention by Reducing Rumination (Worry)
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia.
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment.
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment.
Description
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.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Title
Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters.
Description
Sleep parameters as captured by self-reported sleep onset latency, wake after sleep onset, and sleep efficiency.
Time Frame
Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L Drake, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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