NCT00949689

Young Adult and Teen Sleep Study

Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

This study will develop and test a youth cognitive behavioral insomnia intervention to be employed as an adjunct to depression-focused cognitive behavioral treatments. The primary goal of the study is to improve the treatment and prevention of youth depression beyond that achieved with depression-focused pharmacotherapy and psychotherapies. The investigators' ultimate aim in developing this intervention is to enable a series of future outcome trials focused on improving unipolar depression outcomes in youth with comorbid insomnia, by addressing sleep dysfunction. The study will be recruiting from Kaiser Health Plan members in the Portland,Oregon metropolitan area and participants from the Bay Area region of California.

Detailed description

This controlled clinical trial (RCT) will be conducted at the Portland and UC Berkeley sites, directed respectively by Drs. Clarke and Harvey. We are conducting this small RCT at both sites is to establish the feasibility of conducting a fully-powered RCT at multiple sites to be funded by a later, separate R01 application.. Our goal is to enroll 20-30 cases at each of the two sites, for a total of up to 60 youth (30 per study condition). We propose to enroll this modest sample over a 12 month recruitment period. We expect facilitated referrals from several sources, different at each site. In Portland recruitment will be from the 16 HMO pediatric clinics in the Portland metropolitan area. In Berkeley recruitment will come in part from another region of the same HMO, with referrals facilitated by the Kaiser Permanente Department of Research in Oakland, a sister organization to Dr. Clarke's Center for Health Research (CHR) in Kaiser's Northwest region. Referrals will also come from the UBC Psychology Clinic and Dr. Harvey's Sleep and Psychological Disorders Laboratory. Identified parents and teens will be sent study recruitment letters followed by phone calls to screened for initial eligibility. If the teen appears to be eligible the teen and parent will be scheduled to come to a baseline assessment interview. The baseline assessment is expected to take between 2-3 hours and in appreciation of their time the teen will receive a gift card for $20 and the parent will receive a gift card for $10. If the teen is eligible they will be randomized to either the control arm: sessions in time management and sleep hygiene as well as sessions of cognitive behavioral therapy for depression, or the experimental arm: a combination of CBT therapy sessions for insomnia and depression. Sessions will last from 10-12 weeks. Follow up assessments will be conducted at 12 and 26 weeks for both parent and teen with the same participant incentives as the Baseline. The teen will be asked to wear the ActiGraph watch and keep sleep diary several times throughout their enrollment.

Conditions

• Depression
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for insomnia and depression	Experimental arm: Participants will receive sessions of cognitive behavioral treatment for insomnia followed by sessions of cognitive behavior treatment for depression for a total of about 10-12 therapy sessions Control arm: Participants will receive brief sleep hygiene and time management techniques and cognitive behavior treatment for depression for a total of about 10-12 therapy sessions.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-04-01
• Completion: 2011-08-01
• First posted: 2009-07-30
• Last updated: 2012-11-15

Locations

2 sites across 1 country: United States