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Development of an Insomnia Treatment for Depressed Adolescents

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ClinicalTrials.gov Identifier: NCT02163564
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Deirdre A. Conroy, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Depression Behavioral: Cognitive Behavioral Therapy for Insomnia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of an Insomnia Treatment for Depressed Adolescents
Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Focus groups
The first part of the study is to conduct focus groups of adolescents with insomnia and depression. The treatment arm is informed by responses provided by teens in the focus group portion.
Active Comparator: Treatment
A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.
Behavioral: Cognitive Behavioral Therapy for Insomnia
A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches
Other Name: CBTI




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Sleep diaries [ Time Frame: Change from baseline in sleep at 5 weeks ]
    A subjective assessment of daily patterns of sleep



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163564


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: Deirdre A. Conroy, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02163564    
Other Study ID Numbers: 501
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by Deirdre A. Conroy, University of Michigan:
Adolescent
Depression
Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Behavioral Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases