Sleep Therapy for Insomnia and Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Insomnia
• Intervention / Treatment: Behavioral: Sleep Hygiene; Behavioral: Intensive Sleep Retraining

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sleep Hygiene Group; 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.	Behavioral: Sleep Hygiene; Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.
Active Comparator: Intensive Sleep Retraining Group; 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.	Behavioral: Intensive Sleep Retraining; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks	Clinician-rated depression symptom severity measure	8 weeks after administration of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Score of the Insomnia Severity Index at 8 weeks	Self report measure of insomnia symptoms	8 weeks after administration of intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Leslie Swanson, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HUM00112746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO