Young Adult and Teen Sleep Study
Condition: Depression; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Cognitive Behavioral Therapy for insomnia and depression
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescence; insomnia; depression; sleep problems; cognitive therapy