Back to resultsDevelopment of an Insomnia Treatment for Depressed Adolescents
Primary Purpose
Insomnia, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Adolescent, Depression, Insomnia
Eligibility 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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Focus groups
Treatment
Arm Description
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.
A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.
Outcomes
Primary Outcome Measures
Insomnia Severity Index
A 5-item insomnia severity questionnaire
Multidimensional Fatigue Inventory
A 14-item questionnaire on fatigue
Quick Inventory of Depressive Symptomatology
A 16-item questionnaire on depression
Secondary Outcome Measures
Alcohol and drug use screening test (CRAFFT)
A six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.
Morningness Eveningness Questionnaire -modified
A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02163564
Brief Title
Development of an Insomnia Treatment for Depressed Adolescents
Official Title
Development of an Insomnia Treatment for Depressed Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression
Keywords
Adolescent, Depression, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus groups
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBTI
Intervention Description
A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
A 5-item insomnia severity questionnaire
Time Frame
Change from baseline in insomnia at 5 weeks
Title
Multidimensional Fatigue Inventory
Description
A 14-item questionnaire on fatigue
Time Frame
Change from baseline in fatigue at 5 weeks
Title
Quick Inventory of Depressive Symptomatology
Description
A 16-item questionnaire on depression
Time Frame
Change from baseline in depression at 5 weeks
Secondary Outcome Measure Information:
Title
Alcohol and drug use screening test (CRAFFT)
Description
A six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.
Time Frame
Baseline
Title
Morningness Eveningness Questionnaire -modified
Description
A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Sleep diaries
Description
A subjective assessment of daily patterns of sleep
Time Frame
Change from baseline in sleep at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of an Insomnia Treatment for Depressed Adolescents
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