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

Not Applicable

Completed

• Conditions: Insomnia; Mental Health Functioning; Physical Health Functioning
• Interventions: Behavioral: Sleep Education; Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT03365024
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-07
• Study Start: 2018-04-28
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Intervention 2	Sleep Education	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.
Computerized Intervention 1	Computerized Cognitive Behavioral Therapy for Insomnia	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.

Primary Outcome Measures

Name	Time	Method
Change in Physical Health; Time 1 to Time 3	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.
Change in Mental Health; Time 1 to Time 2	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.
Change in Mental Health; Time 1 to Time 3	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.
Change in Insomnia Symptom Severity; Time 1 to Time 3	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.
Change in Insomnia Symptom Severity; Time 1 to Time 2	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.
Change in Physical Health ; Time 1 to Time 2	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.

Trial Locations

Locations (1)

Rocky Mountain Regional VA; 🇺🇸 Aurora, Colorado, United States