CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression (SleepWell)

December 13, 2018 updated by: Kaiser Permanente

CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes

This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

160 youth with depression and comorbid insomnia who have just initiated a course of SSRI antidepressants will be randomized to insomnia-focused cognitive behavior therapy (CBT-I) or an attention control condition of sleep hygiene (SH) education. All participants will have in-person treatment sessions and will complete sleep diaries and wear an actigraph to record activity levels. Participants will be followed for 12 months.

Primary depression outcomes are score on the Clinical Global Impressions Improvement (CGI-I) and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy total sleep time and score on the Insomnia Severity Index (ISI). Secondary outcomes include additional sleep and depression outcomes. The study will also include economic analyses.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

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
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research/Northwest

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 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 12 to 19
  • Major depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
  • Recent dispense of SSRI antidepressant
  • Subjective complaint of insomnia ≥ one month
  • Score of ≥ 9 on Insomnia Severity Index

Exclusion Criteria:

  • Active, progressive physical illness or neurological degenerative disease
  • Sleep apnea, restless legs, or limb movements during sleep
  • Diagnosis of delayed sleep phase syndrome (DSPS)
  • Mental retardation, autism spectrum disorder (ASD), or other significant pervasive developmental disability (PDD)
  • Sleep treatments including over-the-counter (OTC) sleep medication or CBT for insomnia
  • Medications known to alter sleep
  • Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for Insomnia (CBT-I)
Cognitive behavior therapy to improve sleep and depression.
Behavioral: CBT for Insomnia (CBT-I)
Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
Placebo Comparator: Sleep Hygiene (SH)
Attention control placebo comprising sleep hygiene therapy
Behavioral: Sleep Hygiene (SH)
Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in depression and current severity of depression
Time Frame: 52 weeks from baseline
Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S).
52 weeks from baseline
Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)
Time Frame: 52 weeks from baseline
PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).
52 weeks from baseline
Increase in total sleep time across the study period
Time Frame: 52 weeks from baseline
Total sleep time is calculated from a sleep diary, which participants complete for 2 weeks following each assessment and during active sleep treatment, and from ActiGraph devices, which measure total sleep time and physical activity 24 hours per day during active sleep treatment and for 2 weeks following each assessment.
52 weeks from baseline
Severity of insomnia based on ISI
Time Frame: 52 weeks from baseline
Insomnia severity is measured by the Insomnia Severity Index (ISI)
52 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of depression based on CDRS-R and PHQ-9
Time Frame: 52 weeks from baseline
Severity of depression is measured by the Children's Depression Rating Scale-Revised (CDRS-R) and the Patient Health Questionnaire-Depression (PHQ-9)
52 weeks from baseline

Collaborators and Investigators

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

Sponsor

Kaiser Permanente

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Gregory N. Clarke, PhD, Kaiser Permanente

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 (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH104647 (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.

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