CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CBT for Insomnia (CBT-I)

Cognitive behavior therapy to improve sleep and depression.

Group Type EXPERIMENTAL

CBT for Insomnia (CBT-I)

Intervention Type BEHAVIORAL

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.

Sleep Hygiene (SH)

Attention control placebo comprising sleep hygiene therapy

Group Type PLACEBO_COMPARATOR

Sleep Hygiene (SH)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No