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Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.

Sponsor
Baylor College of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05372185
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
18.2
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VA Coordinated Anxiety Learning and Management- Substance Use Version
  • Behavioral: Usual care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Expanding Reach of Evidence-based Psychotherapy for Rural Veterans With Co-occurring Anxiety and Substance Use Disorders.
Actual Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: VA CALM-S

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.

Behavioral: VA Coordinated Anxiety Learning and Management- Substance Use Version
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.
Active Comparator: Usual Care

Participants in usual care will engage with VA healthcare using standard procedures of their facility.

Behavioral: Usual care
Veterans will engage in VA care using the standard procedures of their facility.

Outcome Measures

Primary Outcome Measures

  1. Generalized Anxiety Disorder-7 [12 weeks]

    Self report measure of anxiety symptoms (score range 0-21), higher scores indicate greater anxiety (i.e., poorer outcome).

Secondary Outcome Measures

  1. Substance use frequency [12 weeks]

    Number of substance use days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michael E DeBakey VAMC Houston Texas United States 77030

Sponsors and Collaborators

  • Baylor College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anthony H Ecker, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT05372185
Other Study ID Numbers:
  • H-48017
First Posted:
May 12, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Anxiety Disorders

Study Results

No Results Posted as of May 18, 2022