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Sleep To Reduce Incident Depression Effectively

NCT03322774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1237

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Big Health Inc.

    collaborator INDUSTRY

  • University of Michigan

    collaborator OTHER

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Christopher L Drake, PhD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2023-04-30
Completion
2024-06-27

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322774 on ClinicalTrials.gov