Anxiety DisorderNCT04871100
Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use
A study testing Unified Protocol- Alcohol in people with Anxiety Disorder and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Posttraumatic Stress Disorder, Hazardous Drinking
- What is being tested?
- Unified Protocol- Alcohol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Sep 2026
- 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
- meeting diagnostic criteria for current anxiety disorder
- endorsing hazardous alcohol use
Who cannot join
- -need for acute medically-supervised detoxification with exclusionary criteria of
- high-risk suicidality
- psychotic symptoms, or
- cognitive impairment that could interfere with engagement in weekly psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
About this study
Official title: Addressing Mental Health Comorbidities: Integrated CBT to Improve Functioning in Veterans With Co-Occurring Anxiety and Substance Use
Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.
Read the detailed description
Co-occurring hazardous drinking, anxiety disorders, and PTSD are problematic combinations of mental health concerns experienced by deployed Veterans. Veterans who have been deployed are at particular risk for experiencing problems in functioning and reintegration related to mental health disorders and hazardous drinking. Co-occurring anxiety and hazardous drinking heavily impact psychosocial functioning and quality of life. Although cognitive behavior therapy (CBT) can promote psychological recovery through improvements in functioning and quality of life, most CBT protocols do not address co-occurring disorders, leading to inefficient and disjointed treatment. The current research seeks to adapt and test the Unified Protocol (UP) for deployed Veterans with hazardous drinking. The use of combined CBT for both anxiety disorders and hazardous drinking has the potential to more efficiently and effectively improve functioning, reduce symptoms, and promote psychosocial recovery.
- Being tested
- Unified Protocol- Alcohol, Usual care
- Keywords
- Veterans, Anxiety, Stress Disorders, Post-Traumatic, Alcohol Drinking, Psychosocial functioning
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol- AlcoholBehavioural
Transdiagnostic cognitive behavior therapy (CBT) for emotional disorders modified to include CBT for alcohol use.
Usual careBehavioural
Referrals to VA care for SUD and anxiety
| Study group | Role | What they receive |
|---|---|---|
| UP-A | Experimental | Cognitive behavior therapy (CBT) using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules. Receives: Behavioral: Unified Protocol- Alcohol |
| Enhanced Usual Care | Active comparator | Referrals to VA care for SUD and anxiety Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Adjustment Scale- Self Report
Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).
Measured: 2-weeks
Beck Anxiety Inventory
Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).
Measured: past 30 days
Addiction Severity Index
Assessment of substance use and related problems. Higher scores in each domain indicate problems related to substance use in that domain (range for each domain 0-1).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Mar 2023
- Primary completion29 May 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- Participants will be randomized to receive the intervention or a control intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anthony Ecker, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871100
- Sponsor's protocol ID
- D3520-W
- Other IDs
- 1IK2RX003520-01A2
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health Comorbidities: Integrated CBT to Improve Functioning in Veterans With Co-Occurring Anxiety and Substance Use
- ClinicalTrials.gov ID
- NCT04871100
- Acronym / sponsor ID
- D3520-W
- Keywords
- Veterans, Anxiety, Stress Disorders, Post-Traumatic, Alcohol Drinking, Psychosocial functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 4 May 2021 (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.
Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.
Detailed description
Co-occurring hazardous drinking, anxiety disorders, and PTSD are problematic combinations of mental health concerns experienced by deployed Veterans. Veterans who have been deployed are at particular risk for experiencing problems in functioning and reintegration related to mental health disorders and hazardous drinking. Co-occurring anxiety and hazardous drinking heavily impact psychosocial functioning and quality of life. Although cognitive behavior therapy (CBT) can promote psychological recovery through improvements in functioning and quality of life, most CBT protocols do not address co-occurring disorders, leading to inefficient and disjointed treatment. The current research seeks to adapt and test the Unified Protocol (UP) for deployed Veterans with hazardous drinking. The use of combined CBT for both anxiety disorders and hazardous drinking has the potential to more efficiently and effectively improve functioning, reduce symptoms, and promote psychosocial recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive the intervention or a control intervention.
| Arm | Type | Receives |
|---|---|---|
| UP-A | Experimental | Behavioral: Unified Protocol- AlcoholCognitive behavior therapy (CBT) using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules. |
| Enhanced Usual Care | Active comparator | Behavioral: Usual careReferrals to VA care for SUD and anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- meeting diagnostic criteria for current anxiety disorder
- endorsing hazardous alcohol use
Key exclusion criteria (4 listed)
- -need for acute medically-supervised detoxification with exclusionary criteria of
- high-risk suicidality
- psychotic symptoms, or
- cognitive impairment that could interfere with engagement in weekly psychotherapy
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 |
|---|---|---|
| Unified Protocol- AlcoholTransdiagnostic cognitive behavior therapy (CBT) for emotional disorders modified to include CBT for alcohol use. | Behavioural | UP-A |
| Usual careReferrals to VA care for SUD and anxiety | Behavioural | Enhanced Usual Care |
Primary outcome
Social Adjustment Scale- Self Report
Time frame: 2-weeks
Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).
Beck Anxiety Inventory
Time frame: past 30 days
Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).
Addiction Severity Index
Time frame: 30 days
Assessment of substance use and related problems. Higher scores in each domain indicate problems related to substance use in that domain (range for each domain 0-1).
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 2 Oct 2026.
- 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.
Anthony Ecker, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol- Alcohol in people with Anxiety Disorder and Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 4 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 2 Oct 2026. 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?
Social Adjustment Scale- Self Report (time frame: 2-weeks). The study lists 3 primary outcomes in all. 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 2 Oct 2026.