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

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT02290496

Collaborator

National Institute of Mental Health (NIMH) (NIH)

165

Enrollment

Location

Arms

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Depression	Behavioral: CBT for Insomnia (CBT-I) Behavioral: Sleep Hygiene (SH)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT for Insomnia (CBT-I) Cognitive behavior therapy to improve sleep and depression.	Behavioral: CBT for Insomnia (CBT-I) 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.
Placebo Comparator: Sleep Hygiene (SH) Attention control placebo comprising sleep hygiene therapy	Behavioral: Sleep Hygiene (SH) 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.

Arm

Intervention/Treatment

Experimental: CBT for Insomnia (CBT-I)

Cognitive behavior therapy to improve sleep and depression.

Behavioral: CBT for Insomnia (CBT-I)

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.

Placebo Comparator: Sleep Hygiene (SH)

Attention control placebo comprising sleep hygiene therapy

Behavioral: Sleep Hygiene (SH)

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.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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