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Development of an Insomnia Treatment for Depressed Adolescents

NCT ID: NCT02163564

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Insomnia Depression

Keywords

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Adolescent Depression Insomnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Behavioral Therapy for Insomnia

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBTI

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Deirdre A. Conroy

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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501

Identifier Type: -

Identifier Source: org_study_id