Anxiety
Conditions
Keywords
anxiety, primary health care, Veterans
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.
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.
Interventions
BEHAVIORALVeterans Anxiety Skills Training Intervention
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
BEHAVIORALPCMHI Usual Care
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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments will be conducted by research assistants who are masked to participant condition
Intervention model description
Randomized clinical trial with randomization to the intervention condition or control condition
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scale-21 Change, Anxiety Subscale | Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks) | 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. |
| Depression Anxiety Stress Scale-21 Change, Depression Subscale | Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobyn L Shepardson, PhD
Syracuse VA Medical Center, Syracuse, NY
Participant flow
Recruitment details
Patient participants were recruited from primary care clinics at the VA Syracuse Healthcare System or VA Western New York Healthcare System at Buffalo from August 2021 through November 2024. Prospective patient participants were identified through case finding from electronic medical records and direct referrals from primary care or behavioral health providers or other studies. Provider participants were recruited via email invitations and Primary Care Mental Health Integration staff meetings.
Pre-assignment details
A telephone screening identified patients eligible based on study eligibility criteria. 8 patient participants who enrolled were not randomized: after consenting, 3 withdrew without completing the baseline, 4 completed part of the baseline but were lost to contact, 1 was determined to be ineligible after baseline. (Providers were also enrolled in this hybrid trial to deliver treatment to the patient participants in both conditions, but did not contribute to Outcome Measures or Adverse Events.)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Patients | 52.66 years STANDARD_DEVIATION 16.5 |
| Age, Continuous Providers | 36.4 years STANDARD_DEVIATION 7.8 |
| Anxiety symptom severity | 10.82 units on a scale STANDARD_DEVIATION 4.1 |
| Anxiety symptom severity level High (GAD-7 score >=15) | 17 Participants |
| Anxiety symptom severity level Low (GAD-7 score <15) | 68 Participants |
| Depression symptom severity | 9.52 units on a scale STANDARD_DEVIATION 4.5 |
| Depression symptom severity level High (PHQ-9 score >=15) | 11 Participants |
| Depression symptom severity level Low (PHQ-9 score <15) | 71 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Providers Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Providers Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Providers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Patients Asian | 2 Participants |
| Race (NIH/OMB) Patients Black or African American | 10 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) Patients White | 68 Participants |
| Race (NIH/OMB) Providers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Providers Asian | 1 Participants |
| Race (NIH/OMB) Providers Black or African American | 1 Participants |
| Race (NIH/OMB) Providers More than one race | 0 Participants |
| Race (NIH/OMB) Providers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Providers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Providers White | 34 Participants |
| Region of Enrollment United States Patients | 167 Participants |
| Region of Enrollment United States Providers | 36 Participants |
| Sex: Female, Male Patients Female | 50 Participants |
| Sex: Female, Male Patients Male | 51 Participants |
| Sex: Female, Male Providers Female | 24 Participants |
| Sex: Female, Male Providers Male | 6 Participants |
| Site Patients VA Syracuse Healthcare System | 47 Participants |
| Site Patients VA Western New York Healthcare System at Buffalo | 35 Participants |
| Site Providers VA Syracuse Healthcare System | 20 Participants |
| Site Providers VA Western New York Healthcare System at Buffalo | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 1 / 83 |
| other Total, other adverse events | 18 / 86 | 14 / 83 |
| serious Total, serious adverse events | 7 / 86 | 6 / 83 |
Outcome results
None listed