Status:
COMPLETED
Sleep To Reduce Incident Depression Effectively
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Big Health Inc.
University of Michigan
Conditions:
Insomnia, Primary
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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 an...
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 o...
Eligibility Criteria
Inclusion
- Determination of Insomnia (ISI \> 14)
- And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology \< 11)
Exclusion
- 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.
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
1237 Patients enrolled
Trial Details
Trial ID
NCT03322774
Start Date
March 9 2018
End Date
June 27 2024
Last Update
October 1 2024
Active Locations (1)
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1
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377