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Sleep Therapy for Insomnia and Depression

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University of Michigan

Status

Completed

Conditions

Insomnia
Depression

Treatments

Behavioral: Intensive Sleep Retraining
Behavioral: Sleep Hygiene

Study type

Interventional

Funder types

Other

Identifiers

NCT02943278
HUM00112746

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

13 participants in 2 patient groups, including a placebo group

Sleep Hygiene Group
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Sleep Hygiene
Intensive Sleep Retraining Group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Intensive Sleep Retraining

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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