CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Insomnia, Depression

In brief

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.

Key facts

Study ID

NCT02290496

Run by

Kaiser Permanente

People needed

165

Starts

2015-03-01

Expected to finish

2018-07-01

Last updated by the study team

2018-12-17

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Center for Health Research/Northwest — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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