CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
NCT ID: NCT02290496
Last Updated: 2018-12-17
Study Results
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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COMPLETED
NA
165 participants
INTERVENTIONAL
2015-03-31
2018-07-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CBT for Insomnia (CBT-I)
Cognitive behavior therapy to improve sleep and depression.
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.
Sleep Hygiene (SH)
Attention control placebo comprising sleep hygiene therapy
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
19 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Gregory N. Clarke, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Center for Health Research/Northwest
Portland, Oregon, United States
Countries
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References
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