Young Adult and Teen Sleep Study
YATSS
Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression
1 other identifier
interventional
41
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 15, 2012
October 1, 2011
1.6 years
July 29, 2009
November 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression remission
2 years
Secondary Outcomes (1)
Improved sleep
2 years
Study Arms (2)
Cognitive Behavioral Therapy for insomnia and depression
EXPERIMENTALcognitive behavioral therapy for insomnia followed by cognitive behavioral therapy for depression
contol
ACTIVE COMPARATORparticipants will receive sleep hygiene, time management techniques and cognitive therapy for depression
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- University of California, Berkeleycollaborator
Study Sites (2)
University of California at Berkeley
Berkeley, California, 94720-1650, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
Related Publications (1)
Clarke G, McGlinchey EL, Hein K, Gullion CM, Dickerson JF, Leo MC, Harvey AG. Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial. Behav Res Ther. 2015 Jun;69:111-8. doi: 10.1016/j.brat.2015.04.009. Epub 2015 Apr 14.
PMID: 25917009DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory N Clarke, PhD
Kaiser Permanente
- STUDY DIRECTOR
Allison G Harvey, PhD
University of California at Berkeley
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
September 1, 2009
Primary Completion
April 1, 2011
Study Completion
August 1, 2011
Last Updated
November 15, 2012
Record last verified: 2011-10