Development of an Insomnia Treatment for Depressed Adolescents

Not Applicable

Completed

• Conditions: Insomnia; Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT02163564
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-13
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Cognitive Behavioral Therapy for Insomnia	A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Change from baseline in insomnia at 5 weeks	A 5-item insomnia severity questionnaire
Multidimensional Fatigue Inventory	Change from baseline in fatigue at 5 weeks	A 14-item questionnaire on fatigue
Quick Inventory of Depressive Symptomatology	Change from baseline in depression at 5 weeks	A 16-item questionnaire on depression

Secondary Outcome Measures

Name	Time	Method
Alcohol and drug use screening test (CRAFFT)	Baseline	A six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.
Morningness Eveningness Questionnaire -modified	Baseline	A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States