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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05372185
Other study ID # H-48017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date March 30, 2024

Study information

Verified date May 2024
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 30, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Michael E DeBakey VAMC Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Generalized Anxiety Disorder-7 Self report measure of anxiety symptoms (score range 0-21), higher scores indicate greater anxiety (i.e., poorer outcome). 12 weeks
Secondary Substance use frequency Number of substance use days 12 weeks
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