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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Mental Health Functioning; Physical Health Functioning
• Intervention / Treatment: Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Education

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Currently enrolled in/participating in other intervention research studies
2. Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
3. Currently receiving formal psychological treatment for insomnia (not including sleep medications)
4. Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
5. History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
6. Untreated seizures or seizure disorder
7. Physical illness that is active, unstable, degenerative, and/or progressive
8. Currently pregnant or plan to become pregnant in the next 6 months
9. Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
10. Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
11. 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
12. Current alcohol use diagnosis, as determined by SCID 5 module, in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Computerized Intervention 1; A web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.	Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia; A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.; Other Names: cCBT-I
ACTIVE_COMPARATOR: Computerized Intervention 2; A web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.	Behavioral: Sleep Education; A web-based program will deliver components of sleep education via an Internet platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Symptom Severity; Time 1 to Time 2	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.	Baseline and 9 weeks
Change in Mental Health; Time 1 to Time 2	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.	Baseline and 9 weeks
Change in Physical Health ; Time 1 to Time 2	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.	Baseline and 9 weeks
Change in Insomnia Symptom Severity; Time 1 to Time 3	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.	Baseline and 6 Months
Change in Mental Health; Time 1 to Time 3	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.	Baseline and 6 Months
Change in Physical Health; Time 1 to Time 3	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.	Baseline and 6 Months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2018
• Primary Completion (ACTUAL): July 16, 2019
• Study Completion (ACTUAL): July 16, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Insomnia; CBT-I
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Self-Injurious Behavior; Sleep Initiation and Maintenance Disorders; Suicide
• Other Study ID Numbers: 17-1056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No