Young Adult and Teen Sleep Study (YATSS)

November 14, 2012 updated by: Kaiser Permanente

Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720-1650
        • University of California at Berkeley
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression remission
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved sleep
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

University of California, Berkeley

Investigators

  • Principal Investigator: Gregory N Clarke, PhD, Kaiser Permanente
  • Study Director: Allison G Harvey, PhD, University of California at Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH082034-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Cognitive Behavioral Therapy for insomnia and depression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe