AnxietyNCT04829240
Brief Anxiety Skills Training Intervention for Veterans in Primary Care
A study testing Veterans Anxiety Skills Training Intervention in people with Anxiety, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Anxiety symptoms are common among primary care patients, but anxiety is undertreated. Brief behavioral (non-medication) anxiety treatments are needed. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms and impairment in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Veterans Anxiety Skills Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Patient Inclusion Criteria:
- Veteran,
- Age >=18 years,
- Seen in the Syracuse or Western New York VAMC or CBOC primary care clinic in the past 12 months,
- Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (>= 8 on GAD7)
Provider Inclusion Criteria:
- Current behavioral health provider working in Primary Care-Mental Health Integration (PCMHI) at the VA Syracuse or VA Western New York healthcare system, including full-time, part-time, and trainee status
Patient Exclusion Criteria:
- Inability to communicate in English (as assessed by study staff);
- Hearing impairment that precludes completion of telephone eligibility screening (as assessed by study staff);
- Cognitive impairment that precludes informed consent, defined as any of the following:
- not able to comprehend the study description or eligibility screening as assessed by study staff,
- diagnosis of dementia or severe cognitive impairment per self-report, primary care provider, or Problem List, or
- screen positive for cognitive impairment (>= 3 errors on screener);
- Diagnosis of Obsessive-Compulsive Disorder (OCD) or serious mental illness (SMI, i.e., psychotic disorders, bipolar disorder) in Problem List;
- Encounter diagnosis of Posttraumatic Stress Disorder (PTSD) within the past 2 years or screen positive for PTSD (>= 4 for men or >= 5 for women on the Primary Care PTSD Screen for DSM-5;
- Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of the following within the past 30 days:
- attending >= 1 non-intake specialty mental health session,
- attending >= 2 PCMHI sessions, or
- being hospitalized for mental health treatment;
- Current (past 2 weeks) severe depressive symptoms (>= 20 on PHQ9);
- At imminent risk of suicide, defined as being in need of intensive treatment (e.g., hospitalization) to ensure safety, based on study staff's suicide risk assessment (verified by the PI);
- Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days
Provider Exclusion Criteria:
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
Official title: Improving Anxiety Treatment Engagement and Effectiveness in Primary Care-Mental Health Integration: Multi-site Hybrid I RCT of a Brief Veteran-Centered Anxiety Intervention
Anxiety symptoms are common among primary care patients, but anxiety is undertreated. Brief behavioral (non-medication) anxiety treatments are needed. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms and impairment in Veterans compared to usual care. The brief anxiety treatment, Veterans Anxiety Skills Training (VAST), was designed to be evidence-based (emphasis on cognitive-behavioral skills), transdiagnostic (applicable to a wide range of anxiety symptoms), feasible for integrated primary care (no more than 6 brief [30-minute] sessions), and Veteran-centered (tailored to Veterans and personalized to individual patients). A total of 170 adult Veteran primary care patients from the Syracuse and Western New York VA healthcare systems who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The investigators will compare anxiety symptom severity and functional impairment between the two groups at baseline and at post-assessment (at 16 weeks) and follow-up assessment (at 28 weeks). The investigators will also examine predictors of treatment response among those receiving VAST and whether providers deliver VAST as intended.
Read the detailed description
Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of behavioral treatment are low. Primary Care-Mental Health Integration (PCMHI), in which mental health clinicians embedded in primary care provide brief treatment, affords an opportunity to address this treatment gap. However, behavioral interventions that are compatible with the brief PCMHI treatment format and able to accommodate a wide range of anxiety presentations are needed. Accordingly, Veterans Anxiety Skills Training (VAST) was designed to be evidence-based, transdiagnostic, feasible for PCMHI, and Veteran-centered. VAST consists of empirically-supported cognitive-behavioral therapy techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI.
Objectives: The specific aims of this study are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post), and also examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants receiving VAST, explore patient-level predictors of (a) early (8 weeks) and (b) overall (16 weeks) treatment response; and (3) Conduct a mixed-methods process evaluation of VAST implementation to examine rates of, barriers to, and facilitators of achieving and sustaining high-fidelity intervention delivery.
Methods: In this multi-site, hybrid type I effectiveness-implementation randomized clinical trial, 170 adult Veterans with elevated anxiety symptoms will be recruited from primary care at the Syracuse and Western New York VA Medical Centers (VAMCs) and Community-Based Outpatient Clinics (CBOCs). PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and Veteran participants will be randomized to condition. VAST (up to six 30-minute sessions) consists of a standard initial and final session as well as up to 4 cognitive-behavioral skills modules. The primary outcome (Overall Anxiety Severity and Impairment Scale [OASIS]) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 16 weeks (post) and 28 weeks (follow-up). Symptom severity and impairment will also be assessed at 4, 8, and 12 weeks as part of Aim 2. The fidelity of VAST delivery by PCMHI providers will be measured and tracked, and VAST providers will complete semi-structured interviews at the beginning and end of the study.
Analytic plan: Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to post (16 weeks) for participants receiving VAST compared to PCMHI usual care. The primary analysis will be conducted using the intention-to-treat approach. Multi-level modeling will also be used to examine group differences in the secondary outcomes at post (16 weeks) and the primary outcomes at follow-up (28 weeks). Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response (defined as a decrease of 4 or more points on the OASIS). A mixed-methods process evaluation will examine the proportion of PCMHI providers who achieve and sustain high-fidelity VAST delivery as well as barriers to and facilitators of high-fidelity delivery.
- Conditions
- Anxiety
- Being tested
- Veterans Anxiety Skills Training Intervention, PCMHI Usual Care
- Keywords
- anxiety, primary health care, Veterans
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veterans Anxiety Skills Training InterventionBehavioural
Also called Modular Anxiety Skills Training for Veterans
Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
PCMHI Usual CareBehavioural
Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans Receives: Behavioral: Veterans Anxiety Skills Training Intervention |
| Control condition | Active comparator | Usual care anxiety treatment Receives: Behavioral: PCMHI Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Anxiety Severity and Impairment Scale Change
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating more severity and impairment.
Measured: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Secondary outcomes (2)
Depression Anxiety Stress Scale-21 Change, Anxiety Subscale
The secondary outcome of anxiety symptom severity will be measured with the 7-item anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). Participants indicate how much each items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Subscale total scores range from 0 to 42 (raw score range of 0 to 21 is multiplied by 2), with higher scores indicating worse symptom severity. This measure has good psychometric properties in both clinical and non-clinical samples.
Measured: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Depression Anxiety Stress Scale-21 Change, Depression Subscale
The secondary outcome of depression symptom severity will be measured with the 7-item depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). Participants indicate how much each item applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Subscale total scores range from 0 to 42 (raw score range of 0 to 21 is multiplied by 2), with higher scores indicating worse symptom severity. This measure has good psychometric properties in both clinical and non-clinical samples.
Measured: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start17 Aug 2021
- Primary completion31 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies 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
- Randomized clinical trial with randomization to the intervention condition or control condition
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robyn L Shepardson, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829240
- Sponsor's protocol ID
- IIR 20-146
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2021
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Anxiety Treatment Engagement and Effectiveness in Primary Care-Mental Health Integration: Multi-site Hybrid I RCT of a Brief Veteran-Centered Anxiety Intervention
- ClinicalTrials.gov ID
- NCT04829240
- Acronym / sponsor ID
- IIR 20-146
- Conditions
- Anxiety
- Keywords
- anxiety, primary health care, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety symptoms are common among primary care patients, but anxiety is undertreated. Brief behavioral (non-medication) anxiety treatments are needed. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms and impairment in Veterans compared to usual care. The brief anxiety treatment, Veterans Anxiety Skills Training (VAST), was designed to be evidence-based (emphasis on cognitive-behavioral skills), transdiagnostic (applicable to a wide range of anxiety symptoms), feasible for integrated primary care (no more than 6 brief [30-minute] sessions), and Veteran-centered (tailored to Veterans and personalized to individual patients). A total of 170 adult Veteran primary care patients from the Syracuse and Western New York VA healthcare systems who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The investigators will compare anxiety symptom severity and functional impairment between the two groups at baseline and at post-assessment (at 16 weeks) and follow-up assessment (at 28 weeks). The investigators will also examine predictors of treatment response among those receiving VAST and whether providers deliver VAST as intended.
Detailed description
Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of behavioral treatment are low. Primary Care-Mental Health Integration (PCMHI), in which mental health clinicians embedded in primary care provide brief treatment, affords an opportunity to address this treatment gap. However, behavioral interventions that are compatible with the brief PCMHI treatment format and able to accommodate a wide range of anxiety presentations are needed. Accordingly, Veterans Anxiety Skills Training (VAST) was designed to be evidence-based, transdiagnostic, feasible for PCMHI, and Veteran-centered. VAST consists of empirically-supported cognitive-behavioral therapy techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI.
Objectives: The specific aims of this study are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post), and also examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants receiving VAST, explore patient-level predictors of (a) early (8 weeks) and (b) overall (16 weeks) treatment response; and (3) Conduct a mixed-methods process evaluation of VAST implementation to examine rates of, barriers to, and facilitators of achieving and sustaining high-fidelity intervention delivery.
Methods: In this multi-site, hybrid type I effectiveness-implementation randomized clinical trial, 170 adult Veterans with elevated anxiety symptoms will be recruited from primary care at the Syracuse and Western New York VA Medical Centers (VAMCs) and Community-Based Outpatient Clinics (CBOCs). PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and Veteran participants will be randomized to condition. VAST (up to six 30-minute sessions) consists of a standard initial and final session as well as up to 4 cognitive-behavioral skills modules. The primary outcome (Overall Anxiety Severity and Impairment Scale [OASIS]) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 16 weeks (post) and 28 weeks (follow-up). Symptom severity and impairment will also be assessed at 4, 8, and 12 weeks as part of Aim 2. The fidelity of VAST delivery by PCMHI providers will be measured and tracked, and VAST providers will complete semi-structured interviews at the beginning and end of the study.
Analytic plan: Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to post (16 weeks) for participants receiving VAST compared to PCMHI usual care. The primary analysis will be conducted using the intention-to-treat approach. Multi-level modeling will also be used to examine group differences in the secondary outcomes at post (16 weeks) and the primary outcomes at follow-up (28 weeks). Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response (defined as a decrease of 4 or more points on the OASIS). A mixed-methods process evaluation will examine the proportion of PCMHI providers who achieve and sustain high-fidelity VAST delivery as well as barriers to and facilitators of high-fidelity delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with randomization to the intervention condition or control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Veterans Anxiety Skills Training InterventionModular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans |
| Control condition | Active comparator | Behavioral: PCMHI Usual CareUsual care anxiety treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Veterans Anxiety Skills Training InterventionAlso: Modular Anxiety Skills Training for VeteransModular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms | Behavioural | Intervention condition |
| PCMHI Usual CareAppointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care | Behavioural | Control condition |
Primary outcome
Overall Anxiety Severity and Impairment Scale Change
Time frame: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating more severity and impairment.
2 secondary outcomes
Depression Anxiety Stress Scale-21 Change, Anxiety Subscale
Time frame: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Depression Anxiety Stress Scale-21 Change, Depression Subscale
Time frame: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Robyn L Shepardson, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veterans Anxiety Skills Training Intervention in people with Anxiety, run by VA Office of Research and Development at 2 sites 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?
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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Anxiety Severity and Impairment Scale Change (time frame: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 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 7 Aug 2026.