- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05372185
Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
December 11, 2023 updated by: Anthony H Ecker, Baylor College of Medicine
Expanding Reach of Evidence-based Psychotherapy for Rural Veterans With Co-occurring Anxiety and Substance Use Disorders.
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anthony Ecker, PhD
- Phone Number: 713-440-4486
- Email: anthony.ecker@va.gov
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Michael E DeBakey VAMC
-
Contact:
- Anthony Ecker, PhD
- Phone Number: 713-440-4486
- Email: anthony.ecker@va.gov
-
Principal Investigator:
- Anthony Ecker, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Veterans will engage in VA care using the standard procedures of their facility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance use frequency
Time Frame: 12 weeks
|
Number of substance use days
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2022
Primary Completion (Estimated)
February 29, 2024
Study Completion (Estimated)
March 30, 2024
Study Registration Dates
First Submitted
May 9, 2022
First Submitted That Met QC Criteria
May 9, 2022
First Posted (Actual)
May 12, 2022
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-48017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Disorders
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on VA Coordinated Anxiety Learning and Management- Substance Use Version
-
University of California, Los AngelesUniversity of California, San FranciscoWithdrawnDepression | Depression, Postpartum | Anxiety | Pregnancy Related | CBTUnited States
-
Stanford UniversityTerminatedSocial AnxietyUnited States
-
VA Office of Research and DevelopmentActive, not recruitingCocaine Use DisorderUnited States
-
Johns Hopkins UniversityNorth American Spine SocietyCompletedLumbar Spinal Stenosis | Lumbar Spine Degeneration | Lumbar Spinal InstabilityUnited States
-
Uppsala UniversityThe Kamprad Family Foundation for Entrepreneurship, Research & CharityRecruitingOpioid Use Disorder | Alcohol Use Disorder | Opioid Use | Pain, ChronicSweden
-
Central Hospital, Nancy, FranceRecruitingCardiovascular Diseases | Risk Factors | Nutrition | Cohort Studies | GenotypeFrance