Status:
COMPLETED
Young Adult and Teen Sleep Study
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
University of California, Berkeley
Conditions:
Depression
Insomnia
Eligibility:
All Genders
12-20 years
Phase:
PHASE2
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...
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 esta...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00949689
Start Date
September 1 2009
End Date
August 1 2011
Last Update
November 15 2012
Active Locations (2)
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1
University of California at Berkeley
Berkeley, California, United States, 94720-1650
2
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227