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Sleep Therapy for Insomnia and Depression

Primary Purpose

Depression, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Sleep Retraining
Sleep Hygiene
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sleep Hygiene Group

Intensive Sleep Retraining Group

Arm Description

Participants assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things they can do to improve their sleep.

Participants assigned to this group will spend just over 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake the participant up after a few minutes if they fall asleep.

Outcomes

Primary Outcome Measures

Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
Clinician-rated depression symptom severity measure

Secondary Outcome Measures

Change from Baseline Score of the Insomnia Severity Index at 8 weeks
Self report measure of insomnia symptoms

Full Information

First Posted
October 21, 2016
Last Updated
July 25, 2018
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02943278
Brief Title
Sleep Therapy for Insomnia and Depression
Official Title
Sleep Therapy for Insomnia and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Hygiene Group
Arm Type
Placebo Comparator
Arm Description
Participants assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things they can do to improve their sleep.
Arm Title
Intensive Sleep Retraining Group
Arm Type
Active Comparator
Arm Description
Participants assigned to this group will spend just over 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake the participant up after a few minutes if they fall asleep.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Sleep Retraining
Intervention Description
Participants in this group you will spend just over 1 day at our sleep lab, starting around their usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake participants up after a few minutes if they fall asleep.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene
Intervention Description
Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.
Primary Outcome Measure Information:
Title
Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
Description
Clinician-rated depression symptom severity measure
Time Frame
8 weeks after administration of intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Score of the Insomnia Severity Index at 8 weeks
Description
Self report measure of insomnia symptoms
Time Frame
8 weeks after administration of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Swanson, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Therapy for Insomnia and Depression

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