Young Adult and Teen Sleep Study (YATSS)

This study has been completed.
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00949689
First received: July 29, 2009
Last updated: November 14, 2012
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Depression
Insomnia
Behavioral: Cognitive Behavioral Therapy for insomnia and depression
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Depression remission [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved sleep [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy for insomnia and depression
cognitive behavioral therapy for insomnia followed by cognitive behavioral therapy for depression
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.
Active Comparator: contol
participants will receive sleep hygiene, time management techniques and cognitive therapy for depression
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949689

Locations
United States, California
University of California at Berkeley
Berkeley, California, United States, 94720-1650
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
University of California, Berkeley
Investigators
Principal Investigator: Gregory N Clarke, PhD Kaiser Permanente
Study Director: Allison G Harvey, PhD University of California at Berkeley
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00949689     History of Changes
Obsolete Identifiers: NCT00961584
Other Study ID Numbers: 1 R34 MH082034-01A1
Study First Received: July 29, 2009
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
adolescence
insomnia
depression
sleep problems
cognitive therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014