CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression (SleepWell)

Kaiser Permanente

Status: Completed

Conditions: Insomnia; Depression

Treatments: Behavioral: CBT for Insomnia (CBT-I); Behavioral: Sleep Hygiene (SH)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02290496

R01MH104647 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 165 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups, including a placebo group

CBT for Insomnia (CBT-I)

Experimental group

Description:

Cognitive behavior therapy to improve sleep and depression.

Treatment:

Behavioral: CBT for Insomnia (CBT-I)

Sleep Hygiene (SH)

Placebo Comparator group

Description:

Attention control placebo comprising sleep hygiene therapy

Treatment:

Behavioral: Sleep Hygiene (SH)