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

NCT05372185 | Completed

• 1 other identifier: H-48017
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorders; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Substance use frequency

  12 weeks

Study Arms (2)

VA CALM-S

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

VA Coordinated Anxiety Learning and Management- Substance Use Version BEHAVIORAL

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.

VA CALM-S

Usual care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current anxiety disorder diagnosis
• current SUD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E DeBakey VAMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: April 25, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 30, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)