Major Depressive Disorder Clinical Trial
— STRIDEOfficial title:
Sleep To Reduce Incident Depression Effectively
Verified date | July 2023 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1237 |
Est. completion date | March 9, 2024 |
Est. primary completion date | March 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Medical Center - Columbus | Novi | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System | Big Health Inc., University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. | |
Secondary | 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. | Baseline, upon treatment completion, and then 1 and 2 years after initial randomization. |
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