Sleep Therapy for Insomnia and Depression

Depression Clinical Trial

Official title:

Sleep Therapy for Insomnia and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943278
• Other study ID #: HUM00112746
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Score of the Insomnia Severity Index at 8 weeks	Self report measure of insomnia symptoms	8 weeks after administration of intervention