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Clinical Trials/NCT02943278
NCT02943278
Completed
Not Applicable

Sleep Therapy for Insomnia and Depression

University of Michigan1 site in 1 country13 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Michigan
Enrollment
13
Locations
1
Primary Endpoint
Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

In this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to see how these sleep therapies help insomnia in people with depression.

Detailed Description

The first group is the sleep hygiene group. If you are assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things you can do to improve your sleep. The second group is the intensive sleep retraining group. If you are in this group you will spend about 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period you will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes if you fall asleep. For both groups, after the treatment session, you will complete questionnaires online and talk with a study clinician who will ask you questions about your mood every two weeks for 8 weeks.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leslie Swanson

Clinical Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Experiencing depression
  • Experiencing chronic insomnia
  • Have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. This medication must be prescribed by a doctor at the University of Michigan. OR not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks.

Exclusion Criteria

  • Have psychiatric conditions or sleep disorders other than depression or insomnia
  • Have a chronic medical condition that could negatively affect your sleep or mood
  • Are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)

Outcomes

Primary Outcomes

Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks

Time Frame: 8 weeks after administration of intervention

Clinician-rated depression symptom severity measure

Secondary Outcomes

  • Change from Baseline Score of the Insomnia Severity Index at 8 weeks(8 weeks after administration of intervention)

Study Sites (1)

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