Development of an Insomnia Treatment for Depressed Adolescents

Study Overview
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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.

Official Title
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Development of an Insomnia Treatment for Depressed Adolescents

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Focus groups<br>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<br>A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches<br>* Other names: CBTI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Depression, Insomnia