Anxiety DisordersNCT05372185
Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
A study testing VA Coordinated Anxiety Learning and Management- Substance Use Version in people with Anxiety Disorders and Substance Use Disorders, run by Baylor College of Medicine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Substance Use Disorders
- What is being tested?
- VA Coordinated Anxiety Learning and Management- Substance Use Version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current anxiety disorder diagnosis
- current SUD
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Anxiety Disorders, Substance Use Disorders
- Being tested
- VA Coordinated Anxiety Learning and Management- Substance Use Version, Usual care
- Medical subject headings
- Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA Coordinated Anxiety Learning and Management- Substance Use VersionBehavioural
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 careBehavioural
Veterans will engage in VA care using the standard procedures of their facility.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7
Self report measure of anxiety symptoms (score range 0-21), higher scores indicate greater anxiety (i.e., poorer outcome).
Measured: 12 weeks
Secondary outcomes (1)
Substance use frequency
Number of substance use days
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start25 Apr 2022
- Primary completion28 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony H Ecker, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372185
- Sponsor's protocol ID
- H-48017
- Status last verified
- May 2024
- First submitted
- 9 May 2022
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Reach of Evidence-based Psychotherapy for Rural Veterans With Co-occurring Anxiety and Substance Use Disorders.
- ClinicalTrials.gov ID
- NCT05372185
- Acronym / sponsor ID
- H-48017
- Conditions
- Anxiety Disorders, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA CALM-S | Experimental | Behavioral: VA Coordinated Anxiety Learning and Management- Substance Use VersionActive 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. |
| Usual Care | Active comparator | Behavioral: Usual careParticipants in usual care will engage with VA healthcare using standard procedures of their facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current anxiety disorder diagnosis
- current SUD
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA Coordinated Anxiety Learning and Management- Substance Use VersionVA 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. | Behavioural | VA CALM-S |
| Usual careVeterans will engage in VA care using the standard procedures of their facility. | Behavioural | Usual Care |
Primary outcome
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).
1 secondary outcome
Substance use frequency
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA Coordinated Anxiety Learning and Management- Substance Use Version in people with Anxiety Disorders and Substance Use Disorders, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.