Depression Clinical Trial
Official title:
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.
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.
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