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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05372185
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Anthony H Ecker, Baylor College of Medicine

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
Anxiety Disorders Substance Use Disorders Behavioral: VA Coordinated Anxiety Learning and Management- Substance Use Version Behavioral: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 25, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Generalized Anxiety Disorder-7 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Number of substance use days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372185


Contacts
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Contact: Anthony Ecker, PHD 713-440-4486 anthony.ecker@va.gov

Locations
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United States, Texas
Michael E DeBakey VAMC Recruiting
Houston, Texas, United States, 77030
Contact: Anthony Ecker, PhD    713-440-4486    anthony.ecker@va.gov   
Principal Investigator: Anthony Ecker, PhD         
Sponsors and Collaborators
Baylor College of Medicine
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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    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Anxiety Disorders
Pathologic Processes
Mental Disorders
Chemically-Induced Disorders