Sleep Therapy for Insomnia and Depression

Not Applicable

Completed

• Conditions: Insomnia; Depression
• Interventions: Behavioral: Sleep Hygiene; Behavioral: Intensive Sleep Retraining

• Registration Number: NCT02943278
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Status Verified: 2018-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Group	Sleep Hygiene	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.
Intensive Sleep Retraining Group	Intensive Sleep Retraining	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Score of the Insomnia Severity Index at 8 weeks	8 weeks after administration of intervention	Self report measure of insomnia symptoms

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States