Development of an Insomnia Treatment for Depressed Adolescents

NCT02163564 | Completed

• 1 other identifier: 501
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Depression

Keywords

Adolescent; Depression; Insomnia

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index

  A 5-item insomnia severity questionnaire

  Change from baseline in insomnia at 5 weeks

• Multidimensional Fatigue Inventory

  A 14-item questionnaire on fatigue

  Change from baseline in fatigue at 5 weeks

• Quick Inventory of Depressive Symptomatology

  A 16-item questionnaire on depression

  Change from baseline in depression at 5 weeks

Secondary Outcomes (2)

• Alcohol and drug use screening test (CRAFFT)

  Baseline

• Morningness Eveningness Questionnaire -modified

  Baseline

Other Outcomes (1)

• Sleep diaries

  Change from baseline in sleep at 5 weeks

Study Arms (2)

Focus groups

NO INTERVENTION

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.

Treatment

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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

Also known as: CBTI

Treatment

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 13, 2014
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)