Sleep To Reduce Incident Depression Effectively (STRIDE)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    1000
  • sponsor
    Henry Ford Health System
Updated on 14 March 2022
depression
behavior therapy
behavioral therapy
depressive disorder
scid
depressive symptoms
depressed mood
insomnia
cognitive therapy
major depressive disorder
behavior modification
cognitive behavioral therapy for insomnia
cognitive behavior therapy for insomnia

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.

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.

Details
Condition Insomnia, Primary, Major Depressive Disorder, Rumination
Treatment Sleep hygiene education, digital Cognitive Behavioral Therapy for Insomnia, face-to-face Cognitive Behavioral Therapy for Insomnia, Sleep Hygiene Education Control
Clinical Study IdentifierNCT03322774
SponsorHenry Ford Health System
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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