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Completed

NCT Number: NCT03365024

Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk (R-Vets Sleep)

Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Mental Health Functioning Nervous System Diseases Physical Health Functioning Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 and 89
  • Eligible to receive care through VA ECHCS
  • Reliable access to the Internet
  • English speaking
  • Able to provide informed consent
  • Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria

Exclusion criteria

  • Currently enrolled in/participating in other intervention research studies
  • Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
  • Currently receiving formal psychological treatment for insomnia (not including sleep medications)
  • Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
  • History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
  • Untreated seizures or seizure disorder
  • Physical illness that is active, unstable, degenerative, and/or progressive
  • Currently pregnant or plan to become pregnant in the next 6 months
  • Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
  • Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
  • Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (> 1 time) in past 3 months
  • Current alcohol use diagnosis, as determined by SCID 5 module, in the past 3 months

Treatment and study plan

Computerized Cognitive Behavioral Therapy for Insomnia

Behavioral

A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.

Other names: cCBT-I

Sleep Education

Behavioral

A web-based program will deliver components of sleep education via an Internet platform

Primary outcomes

  1. Change in Insomnia Symptom Severity; Time 1 to Time 2

    Time frame: Baseline and 9 weeks

    The primary analysis will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the Insomnia Severity Index (ISI) from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  2. Change in Mental Health; Time 1 to Time 2

    Time frame: Baseline and 9 weeks

    The primary analysis will be the intent-to-treat comparison between groups of the change in Mental Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  3. Change in Physical Health ; Time 1 to Time 2

    Time frame: Baseline and 9 weeks

    The primary analysis will be the intent-to-treat comparison between groups of the change in Physical Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  4. Change in Insomnia Symptom Severity; Time 1 to Time 3

    Time frame: Baseline and 6 Months

    A similar analysis will be performed for the above noted insomnia symptom severity outcome on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

  5. Change in Mental Health; Time 1 to Time 3

    Time frame: Baseline and 6 Months

    A similar analysis will be performed for the above noted Mental Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

  6. Change in Physical Health; Time 1 to Time 3

    Time frame: Baseline and 6 Months

    A similar analysis will be performed for the above noted Physical Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk

Acronym: R-Vets Sleep

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2017
Registry last updated
Jul 28, 2021

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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