CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

Not Applicable

Completed

• Conditions: Depression; Insomnia
• Interventions: Behavioral: Sleep Hygiene (SH); Behavioral: CBT for Insomnia (CBT-I)

• Registration Number: NCT02290496
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Study Start: 2015-03
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene (SH)	Sleep Hygiene (SH)	Attention control placebo comprising sleep hygiene therapy
CBT for Insomnia (CBT-I)	CBT for Insomnia (CBT-I)	Cognitive behavior therapy to improve sleep and depression.

Primary Outcome Measures

Name	Time	Method
Improvement in depression and current severity of depression	52 weeks from baseline	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).
Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)	52 weeks from baseline	PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).
Increase in total sleep time across the study period	52 weeks from baseline	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.
Severity of insomnia based on ISI	52 weeks from baseline	Insomnia severity is measured by the Insomnia Severity Index (ISI)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaiser Permanente Center for Health Research/Northwest; 🇺🇸 Portland, Oregon, United States