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CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

NCT02290496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2018-12-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Gregory N. Clarke, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290496 on ClinicalTrials.gov