Brief Anxiety Skills Training Intervention for Veterans in Primary Care

NCT04829240 | Completed DMC

• 1 other identifier: IIR 20-146
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Anxiety

Keywords

anxiety; primary health care; Veterans

Outcome Measures

Primary Outcomes (1)

• 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. For Aim 1, we will examine change from Baseline to Post-assessment (16 weeks) and from Post-assessment (16 weeks) to Follow-up assessment (28 weeks). For Aim 2, we will examine treatment response occurring from Baseline to (a) 8 weeks (4 \& 8 weeks) and (b) Post-assessment (12 \& 16 weeks).

  Baseline, 4 weeks, 8 weeks, 12 weeks, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

Secondary Outcomes (1)

• Depression Anxiety Stress Scale-21 change

  Baseline, 4 weeks, 8 weeks, 12 weeks, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

Other Outcomes (3)

• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form change

  Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

• Sheehan Disability Scale change

  Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

• Columbia-Suicide Severity Rating Scale change

  Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

Study Arms (2)

Intervention condition

EXPERIMENTAL

Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans

Behavioral: Veterans Anxiety Skills Training Intervention

Control condition

ACTIVE COMPARATOR

Usual care anxiety treatment

Behavioral: PCMHI Usual Care

Interventions

Veterans Anxiety Skills Training Intervention BEHAVIORAL

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

Also known as: Modular Anxiety Skills Training for Veterans

Intervention condition

PCMHI Usual Care BEHAVIORAL

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

Control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Robyn L. Shepardson, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by research assistants who are masked to participant condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial with randomization to the intervention condition or control condition

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: August 17, 2021
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)