Back to resultsEfficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk (Vets Sleep)
Primary Purpose
Insomnia, Physical Health Functioning, Mental Health Functioning
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Behavioral Therapy for Insomnia
Sleep Education
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring CBT-I, Insomnia
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 55
- History of deployment in the Global War on Terror
- 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
Sites / Locations
- Rocky Mountain Regional VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Computerized Intervention 1
Computerized Intervention 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03366870
First Posted
November 28, 2017
Last Updated
June 29, 2020
Sponsor
University of Colorado, Denver
Collaborators
Military Suicide Research Consortium, Denver Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03366870
Brief Title
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
Acronym
Vets Sleep
Official Title
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2018 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Military Suicide Research Consortium, Denver Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Physical Health Functioning, Mental Health Functioning
Keywords
CBT-I, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Intervention 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Computerized Intervention 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
cCBT-I
Intervention Description
A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education
Intervention Description
A web-based program will deliver components of sleep education via an Internet platform.
Primary Outcome Measure Information:
Title
Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index
Description
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.
Time Frame
Baseline and 9 Weeks
Title
Maintenance of Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index at 6-months and 1-Year Post-Intervention
Description
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.
Time Frame
Baseline, 6-Months and 1-Year
Secondary Outcome Measure Information:
Title
Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36
Description
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.
Time Frame
Baseline and 9 Weeks
Title
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
Description
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.
Time Frame
Baseline, 6-Months and 1-Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 55
History of deployment in the Global War on Terror
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarra Nazem, PhD
Organizational Affiliation
VHAECH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
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