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OpenTrials
Completed

NCT Number: NCT02943278

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive Sleep retraining

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.

Sleep Hygiene

Behavioral

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

Primary outcomes

  1. Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks

    Time frame: 8 weeks after administration of intervention

    Clinician-rated depression symptom severity measure

Secondary outcomes

  1. Change from Baseline Score of the Insomnia Severity Index at 8 weeks

    Time frame: 8 weeks after administration of intervention

    Self report measure of insomnia symptoms

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2016
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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