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Completed

NCT Number: NCT02290496

CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research/Northwest

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT for Insomnia (CBT-I)

Behavioral

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.

Sleep Hygiene (SH)

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: SleepWell

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2014
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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