Back to resultsExpanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
Primary Purpose
Anxiety Disorders, Substance Use Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VA Coordinated Anxiety Learning and Management- Substance Use Version
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- current anxiety disorder diagnosis
- current SUD
Exclusion Criteria:
- current substance withdrawal such that medically supervised detoxification is necessary (determined by evaluation of substance use history and report of current symptoms),
- acute suicidality
- current delusions/hallucinations.
Sites / Locations
- Michael E DeBakey VAMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VA CALM-S
Usual Care
Arm Description
Active psychotherapy using VA CALM-S, a weekly (9-12 sessions) cognitive behavioral therapy addressing co-occurring anxiety and substance use disorders, using disorder specific and transdiagnostic tools.
Participants in usual care will engage with VA healthcare using standard procedures of their facility.
Outcomes
Primary Outcome Measures
Generalized Anxiety Disorder-7
Self report measure of anxiety symptoms (score range 0-21), higher scores indicate greater anxiety (i.e., poorer outcome).
Secondary Outcome Measures
Substance use frequency
Number of substance use days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05372185
Brief Title
Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
Official Title
Expanding Reach of Evidence-based Psychotherapy for Rural Veterans With Co-occurring Anxiety and Substance Use Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
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
The current study seeks to better understand how to improve access to evidence-based psychotherapy (EBP) for rural Veterans with co-occurring anxiety and substance use disorders (SUD) using a web-based cognitive behavioral therapy tool (VA Coordinated Anxiety Learning and Management, Substance Use Version; VA CALM-S).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VA CALM-S
Arm Type
Experimental
Arm Description
Active psychotherapy using VA CALM-S, a weekly (9-12 sessions) cognitive behavioral therapy addressing co-occurring anxiety and substance use disorders, using disorder specific and transdiagnostic tools.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants in usual care will engage with VA healthcare using standard procedures of their facility.
Intervention Type
Behavioral
Intervention Name(s)
VA Coordinated Anxiety Learning and Management- Substance Use Version
Intervention Description
VA Coordinated Anxiety Learning and Management- Substance Use Version (VA CALM-S) is a cognitive behavior therapy (CBT) program that employs computer assistance to empower providers to deliver CBT with high fidelity. The computer program guides both providers and patients in a course of CBT, and in this study the content will focus on using transdiagnostic treatment elements to address co-occurring anxiety and substance use disorders.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Veterans will engage in VA care using the standard procedures of their facility.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7
Description
Self report measure of anxiety symptoms (score range 0-21), higher scores indicate greater anxiety (i.e., poorer outcome).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Substance use frequency
Description
Number of substance use days
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
current anxiety disorder diagnosis
current SUD
Exclusion Criteria:
current substance withdrawal such that medically supervised detoxification is necessary (determined by evaluation of substance use history and report of current symptoms),
acute suicidality
current delusions/hallucinations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Ecker, PHD
Phone
713-440-4486
Email
anthony.ecker@va.gov
Facility Information:
Facility Name
Michael E DeBakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Ecker, PhD
Phone
713-440-4486
Email
anthony.ecker@va.gov
First Name & Middle Initial & Last Name & Degree
Anthony Ecker, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
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