Sleep Therapy for Insomnia and Depression

NCT ID: NCT02943278

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-07-31

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.

Conditions

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Depression Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Sleep Hygiene

Intervention Type BEHAVIORAL

Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.

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.

Group Type ACTIVE_COMPARATOR

Intensive Sleep Retraining

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Sleep Hygiene

Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Leslie Swanson

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leslie Swanson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00112746

Identifier Type: -

Identifier Source: org_study_id

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