CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

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