Skip to content

Development of an Insomnia Treatment for Depressed Adolescents

Development of an Insomnia Treatment for Depressed Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02163564
Enrollment
28
Registered
2014-06-13
Start date
2012-04-30
Completion date
2015-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Insomnia

Keywords

Adolescent, Depression, Insomnia

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity IndexChange from baseline in insomnia at 5 weeksA 5-item insomnia severity questionnaire
Multidimensional Fatigue InventoryChange from baseline in fatigue at 5 weeksA 14-item questionnaire on fatigue
Quick Inventory of Depressive SymptomatologyChange from baseline in depression at 5 weeksA 16-item questionnaire on depression

Secondary

MeasureTime frameDescription
Alcohol and drug use screening test (CRAFFT)BaselineA six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.
Morningness Eveningness Questionnaire -modifiedBaselineA 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.

Other

MeasureTime frameDescription
Sleep diariesChange from baseline in sleep at 5 weeksA subjective assessment of daily patterns of sleep

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026