Trial Outcomes & Findings for A Pragmatic Trial of Brief CBT for Anxiety in VA Primary Care (NCT NCT04523779)

Veterans enrolled in Houston, New Orleans, and San Antonio VA Medical Centers were recruited if they: 1) were diagnosed with anxiety disorders and 2) had significant anxiety symptoms (GAD-7 score≥10). Exclusion criteria: 1) cognitive impairment, 2) bipolar or psychotic disorders, 3) substance use disorders, and 4) current psychotherapy for anxiety. Recruitment involved opt-out letters, phone calls, and direct provider referral. Interested Veterans underwent 2 screenings for anxiety.

Eligibility determination occurred after informed consent. Of the 347 Veterans who signed consent forms, many were deemed ineligible at baseline due to various reasons: 1) being unreachable or declining assessment, 2) not meeting the required GAD-7 scores, 3) having an excluded mental health diagnosis, 4) receiving mental health treatment, or 5) relocating outside the catchment area. Ultimately, 225 eligible participants were randomized to treatment (60%) or Enhanced Usual Care (EUC) (40%).

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The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. It is psychometrically strong and valid for use in the primary care setting. A GAD-7 score of 10 or higher will be required for study inclusion. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.

The OASIS will be a secondary measure of anxiety. Unlike the GAD-7, which will be administered by both research staff and PCMHI providers, the OASIS will only be administered by research staff, thereby avoiding response bias that may occur in the clinical setting. The OASIS is a widely used five-item measure of anxiety for primary care settings assessing anxiety frequency, anxiety severity, avoidance behaviors, social interference, and interference at work, school, or home. Each item of the OASIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. A higher score indicates a poorer outcome.

The SF-12-PCS is a condensed, self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning.

The SF12-MCS is a 12-question, patient reported survey evaluating emotional well-being. Mental Health Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators assessed quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning.