Sleep Therapy for Insomnia and Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep Therapy for Insomnia and Depression

Conditions
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Depression, Insomnia

Intervention / Treatment
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* Behavioral: Intensive Sleep Retraining
* Behavioral: Sleep Hygiene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |