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OpenTrials
Completed

NCT Number: NCT02163564

Development of an Insomnia Treatment for Depressed Adolescents

Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 13-19 years of age
  • Are depressed
  • Have insomnia

Exclusion criteria

  • Are not depressed
  • Do not have insomnia
  • Currently using a sleep aid
  • Have bipolar depression
  • Have psychotic disorder
  • Have a sleep disorder other than insomnia

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches

Other names: CBTI

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Change from baseline in insomnia at 5 weeks

    A 5-item insomnia severity questionnaire

  2. Multidimensional Fatigue Inventory

    Time frame: Change from baseline in fatigue at 5 weeks

    A 14-item questionnaire on fatigue

  3. Quick Inventory of Depressive Symptomatology

    Time frame: Change from baseline in depression at 5 weeks

    A 16-item questionnaire on depression

Secondary outcomes

  1. Alcohol and drug use screening test (CRAFFT)

    Time frame: Baseline

    A six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.

  2. Morningness Eveningness Questionnaire -modified

    Time frame: Baseline

    A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.

Other outcomes

  1. Sleep diaries

    Time frame: Change from baseline in sleep at 5 weeks

    A subjective assessment of daily patterns of sleep

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2014
Registry last updated
Jan 29, 2016

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

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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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