Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk (Vets Sleep)

Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. 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) and Department of Defense (DoD). 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): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 55
2. History of deployment in the Global War on Terror
3. Eligible to receive care through VA ECHCS
4. Reliable access to the Internet
5. English speaking
6. Able to provide informed consent
7. 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 Assignment
• 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
Experimental: 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 as Measured by the Insomnia Severity Index	The primary analyses will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the 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 precision of the estimate, and any potential confounders discovered in the randomization check.	Baseline and 9 Weeks
Maintenance of Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index at 6-months and 1-Year Post-Intervention	A similar analysis will be performed for the above noted insomnia severity outcome on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.	Baseline, 6-Months and 1-Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36	A similar analysis will be performed with physical health and mental health functioning as the outcomes, based on self-reported responses to the Veteran's SF-36 measure.	Baseline and 9 Weeks
Maintenance of Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36 at 6-months and 1-Year Post-Intervention	A similar analysis will be performed for the above noted outcomes on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.	Baseline, 6-Months and 1-Year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Denver Research Institute; Military Suicide Research Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2018
• Primary Completion (Actual): June 16, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

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: 17-0920

Drug and device information, study documents

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