Development of an Insomnia Treatment for Depressed Adolescents

Depression Clinical Trial

Official title:

Development of an Insomnia Treatment for Depressed Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163564
• Other study ID #: 501
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: January 28, 2016
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Insomnia

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep diaries	A subjective assessment of daily patterns of sleep	Change from baseline in sleep at 5 weeks	No
Primary	Insomnia Severity Index	A 5-item insomnia severity questionnaire	Change from baseline in insomnia at 5 weeks	No
Primary	Multidimensional Fatigue Inventory	A 14-item questionnaire on fatigue	Change from baseline in fatigue at 5 weeks	No
Primary	Quick Inventory of Depressive Symptomatology	A 16-item questionnaire on depression	Change from baseline in depression at 5 weeks	Yes
Secondary	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	Yes
Secondary	Morningness Eveningness Questionnaire -modified	A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.	Baseline	No