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Sleep Therapy for Insomnia and Depression

Sleep Therapy for Insomnia and Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943278
Enrollment
13
Registered
2016-10-24
Start date
2016-08-31
Completion date
2018-07-31
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Insomnia

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.

Interventions

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.

BEHAVIORALSleep Hygiene

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks8 weeks after administration of interventionClinician-rated depression symptom severity measure

Secondary

MeasureTime frameDescription
Change from Baseline Score of the Insomnia Severity Index at 8 weeks8 weeks after administration of interventionSelf report measure of insomnia symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026