Official Title: “Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: June 2011

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Cognitive Behavioral Therapy for insomnia and depression
  • cognitive behavioral therapy for insomnia follow by cognitive behavioral therapy for depression
• Active Comparator: contol
  • participants will receive sleep hygiene, time management techniques and cognitive therapy for depression

Primary Measures

• Depression remission
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• Improved sleep
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

• Age between 12 and 20, living with a parent or guardian.
• English language fluency.
• Meets DSM-IV criteria for either major depression and/or dysthymia Meets Research
• Diagnostic Criteria (RDC) for insomnia.
• Portland Oregon site participants must be Kaiser Health plan members.

Exclusion Criteria:

• An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease (e.g., multiple sclerosis) directly related to the onset and course of the sleep disturbance.
• Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep.
• Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder.
• Sleep treatment that might confound the interpretation of sleep outcomes.
• Any non-insomnia, non-depressive disorder if the other comorbid condition is clearly the most severe and most impairing of all current diagnoses, and if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study.
• Otherwise, we will allow all other comorbid psychiatric conditions (e.g., anxiety, PTSD).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 20 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kaiser Permanente

Overall Clinical Trial Officials and Contacts

Gregory N Clarke, PhD Principal Investigator Kaiser Permanente  

Overall Contact: Stephanie K Hertert, MEd CCRC 503-335-2411 stephanie.hertert@kpchr.org

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00949689

Study ID Number: 1 R34 MH082034-01A1

ClinicalTrials.gov Identifier: NCT00949689

Health Authority: United States: Institutional Review Board