Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 28, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date December 17, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • 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 Mini Mitter actigraphs, 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
Official Title  ICMJE CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Depression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: CBT for Insomnia (CBT-I)
    Cognitive behavior therapy to improve sleep and depression.
    Intervention: Behavioral: CBT for Insomnia (CBT-I)
  • Placebo Comparator: Sleep Hygiene (SH)
    Attention control placebo comprising sleep hygiene therapy
    Intervention: Behavioral: Sleep Hygiene (SH)
Publications * Clarke G, Sheppler CR, Firemark AJ, Rawlings AM, Dickerson JF, Leo MC. Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial. Contemp Clin Trials. 2020 Apr;91:105967. doi: 10.1016/j.cct.2020.105967. Epub 2020 Feb 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2017)
165
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
160
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290496
Other Study ID Numbers  ICMJE R01MH104647( U.S. NIH Grant/Contract )
R01MH104647 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Gregory N. Clarke, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP