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Young Adult and Teen Sleep Study (YATSS)

Primary Purpose

Depression, Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for insomnia and depression
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring adolescence, insomnia, depression, sleep problems, cognitive therapy

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California at Berkeley
  • Kaiser Permanente Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy for insomnia and depression

contol

Arm Description

cognitive behavioral therapy for insomnia followed by cognitive behavioral therapy for depression

participants will receive sleep hygiene, time management techniques and cognitive therapy for depression

Outcomes

Primary Outcome Measures

Depression remission

Secondary Outcome Measures

Improved sleep

Full Information

First Posted
July 29, 2009
Last Updated
November 14, 2012
Sponsor
Kaiser Permanente
Collaborators
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT00949689
Brief Title
Young Adult and Teen Sleep Study
Acronym
YATSS
Official Title
Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of California, Berkeley

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia
Keywords
adolescence, insomnia, depression, sleep problems, cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for insomnia and depression
Arm Type
Experimental
Arm Description
cognitive behavioral therapy for insomnia followed by cognitive behavioral therapy for depression
Arm Title
contol
Arm Type
Active Comparator
Arm Description
participants will receive sleep hygiene, time management techniques and cognitive therapy for depression
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for insomnia and depression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression remission
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Improved sleep
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory N Clarke, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison G Harvey, PhD
Organizational Affiliation
University of California at Berkeley
Official's Role
Study Director
Facility Information:
Facility Name
University of California at Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25917009
Citation
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.
Results Reference
derived

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Young Adult and Teen Sleep Study

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