CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

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.

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