CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression (SleepWell)
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|ClinicalTrials.gov Identifier: NCT02290496|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Depression||Behavioral: CBT for Insomnia (CBT-I) Behavioral: Sleep Hygiene (SH)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
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.
- Improvement in depression and current severity of depression [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 52 weeks from baseline ]Insomnia severity is measured by the Insomnia Severity Index (ISI)
- Severity of depression based on CDRS-R and PHQ-9 [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290496
|United States, Oregon|
|Kaiser Permanente Center for Health Research/Northwest|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Gregory N. Clarke, PhD||Kaiser Permanente|