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

Primary Purpose

Insomnia, Mental Health Functioning, Physical Health Functioning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Behavioral Therapy for Insomnia
Sleep Education
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring CBT-I, Insomnia

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rocky Mountain Regional VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

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; 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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2017
Last Updated
July 26, 2021
Sponsor
University of Colorado, Denver
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT03365024
Brief Title
Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk (R-Vets Sleep)
Acronym
R-Vets Sleep
Official Title
Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Mental Health Functioning, Physical 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
93 (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
Active Comparator
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; Time 1 to Time 2
Description
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.
Time Frame
Baseline and 9 weeks
Title
Change in Mental Health; Time 1 to Time 2
Description
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.
Time Frame
Baseline and 9 weeks
Title
Change in Physical Health ; Time 1 to Time 2
Description
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.
Time Frame
Baseline and 9 weeks
Title
Change in Insomnia Symptom Severity; Time 1 to Time 3
Description
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.
Time Frame
Baseline and 6 Months
Title
Change in Mental Health; Time 1 to Time 3
Description
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.
Time Frame
Baseline and 6 Months
Title
Change in Physical Health; Time 1 to Time 3
Description
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.
Time Frame
Baseline and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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