CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Behavioral: CBT for Insomnia (CBT-I)
* Behavioral: Sleep Hygiene (SH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for Insomnia (CBT-I)<br>Cognitive behavior therapy to improve sleep and depression. | Behavioral: CBT for Insomnia (CBT-I)<br>* Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.<br>|
| Placebo Comparator: Sleep Hygiene (SH)<br>Attention control placebo comprising sleep hygiene therapy | Behavioral: Sleep Hygiene (SH)<br>* Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in depression and current severity of depression | Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S). | 52 weeks from baseline | 
| Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD) | PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE). | 52 weeks from baseline | 
| Increase in total sleep time across the study period | Total sleep time is calculated from a sleep diary, which participants complete for 2 weeks following each assessment and during active sleep treatment, and from ActiGraph devices, which measure total sleep time and physical activity 24 hours per day during active sleep treatment and for 2 weeks following each assessment. | 52 weeks from baseline | 
| Severity of insomnia based on ISI | Insomnia severity is measured by the Insomnia Severity Index (ISI) | 52 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depression based on CDRS-R and PHQ-9 | Severity of depression is measured by the Children's Depression Rating Scale-Revised (CDRS-R) and the Patient Health Questionnaire-Depression (PHQ-9) | 52 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Depression, Teen, SSRI, Youth, CBT