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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290496
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Insomnia Depression Behavioral: CBT for Insomnia (CBT-I) Behavioral: Sleep Hygiene (SH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. Severity of insomnia based on ISI [ Time Frame: 52 weeks from baseline ]
    Insomnia severity is measured by the Insomnia Severity Index (ISI)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Oregon
Kaiser Permanente Center for Health Research/Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Gregory N. Clarke, PhD Kaiser Permanente
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02290496    
Other Study ID Numbers: R01MH104647 ( U.S. NIH Grant/Contract )
R01MH104647 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Keywords provided by Kaiser Permanente:
Insomnia
Depression
Teen
SSRI
CBT
Youth
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases