Development of an Insomnia Treatment for Depressed Adolescents

January 28, 2016 updated by: Deirdre A. Conroy, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • CBTI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep diaries
Time Frame: Change from baseline in sleep at 5 weeks
A subjective assessment of daily patterns of sleep
Change from baseline in sleep at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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