An interventional study of Brief Cognitive Behavioral Therapy in Anxiety, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
This 4-year study will examine the value of a type of a brief cognitive behavioral therapy treatment for Veterans with anxiety and worry. This treatment will be delivered either in-person, or by video telehealth to the Veteran's home. The treatment will be delivered by providers at three Veterans Administration Medical Centers (Houston, New Orleans, and San Antonio). The study will compare the helpfulness of this treatment to the usual care Veterans receive for anxiety and worry. A supplement to this study will also evaluate daily discrimination experiences of Veterans based on the participant's race, ethnicity, religion, physical appearance, or other characteristics.
This multisite trial (Houston, New Orleans and San Antonio) will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief cognitive behavioral therapy(bCBT) intervention for anxiety delivered either in-person or via VA Video Connect-Home (VVC-H), according to patient preference. Brief CBT will be delivered by existing Primary Care Mental Health Integration (PCMHI) providers at three large VAMCs (Houston, New Orleans, and San Antonio). Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. Enhanced Usual Care (EUC) for anxiety at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. The primary hypothesis is that anxiety outcomes, as measured by the General Anxiety Disorder 7-item scale (GAD-7) will be superior at 4-, 8-, and 12-month follow up for patients who are assigned to receive bCBT vs. EUC.
In addition, participants will be asked to complete the Diversity Supplement measures and qualitative interview to evaluate whether sociocultural factors are associated with the severity and type of anxiety symptoms among Veterans of different race/ethnicity groups.
Exclusion Criteria:
The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Behavioral: Brief Cognitive Behavioral Therapy
EUC participants will receive anxiety education materials, a note in their medical record indicating the presence of elevated anxiety symptoms, and 4 brief monthly check-in calls with project staff. The primary outcome, anxiety symptoms, will be evaluated at 4-, 8- and 12-month follow-ups. Due to ethical concerns of withholding needed treatment, EUC participants will NOT be restricted from receiving mental health services including psychotherapy during the study period. The investigators fully expect that EUC participants may receive anxiety treatments (e.g., antianxiety and antidepressant medications or psychotherapy).
The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Also known as: bCBT
General Anxiety Disorder-7 (GAD-7)
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.
Time frame: Baseline, 4-, 8-, and 12-month
Overall Anxiety Severity and Impairment Scale (OASIS)
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.
Time frame: Baseline, 4-, 8-, and 12-month
Short Form-12 Physical Component Summary (SF-12-PCS)
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.
Time frame: Baseline, 4-, 8-, and 12-month
Short Form-12 Mental Component Summary (SF12-MCS)
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.
Time frame: Baseline, 4-, 8-, 12-month
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.
| Milestone | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Started | 134 | 91 |
| Completed | 134 | 91 |
| Not completed | 0 | 0 |
| Milestone | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Started | 134 | 91 |
| Completed | 114 | 83 |
| Not completed | 20 | 8 |
| Milestone | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Started | 114 | 83 |
| Completed | 111 | 79 |
| Not completed | 3 | 4 |
| Milestone | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Started | 111 | 79 |
| Completed | 106 | 79 |
| Not completed | 5 | 0 |
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.
| score on a scale | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Baseline | 15.4 ± 3.2 | 14.7 ± 3.4 |
| 4 Month | 11.6 ± 5.3 | 12.0 ± 5.1 |
| 8 Month | 10.9 ± 5.2 | 11.9 ± 5.5 |
| 12 Month | 11.0 ± 5.5 | 10.9 ± 6.0 |
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.
| score on a scale | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Baseline | 11.6 ± 3.7 | 11.0 ± 3.4 |
| 4 Month | 9.6 ± 4.6 | 9.7 ± 4.2 |
| 8 Month | 10.2 ± 4.4 | 10.0 ± 4.6 |
| 12 Month | 10.0 ± 4.4 | 9.0 ± 4.7 |
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.
| score on a scale | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Baseline | 39.9 ± 12.3 | 42.2 ± 11.1 |
| 4 Month | 38.5 ± 10.3 | 39.8 ± 11.8 |
| 8 Month | 36.6 ± 11.0 | 39.0 ± 10.8 |
| 12 Month | 37.8 ± 10.8 | 40.0 ± 11.2 |
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.
| score on a scale | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) |
|---|---|---|
| Baseline | 35.6 ± 9.9 | 35.6 ± 11.3 |
| 4 Month | 38.9 ± 9.9 | 37.4 ± 12.0 |
| 8 Month | 38.4 ± 10.9 | 36.0 ± 11.8 |
| 12 Month | 37.6 ± 11.6 | 37.4 ± 12.0 |
Collected over Adverse events were monitored for a 12-month period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | 0/134 (0%) | 0/134 (0%) | 0/134 (0%) |
| Enhanced Usual Care (EUC) | 0/91 (0%) | 0/91 (0%) | 0/91 (0%) |
Following an initial screening, participants who consented were randomized only after a second confirmation of anxiety symptoms. A comprehensive baseline assessment and a chart review for psychotherapy treatment were conducted before making the final determination of study eligibility. Additional participants were consented to reach the final required sample size of 225.
| Age, Customized(Years) | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) | Total |
|---|---|---|---|
| Age at baseline | 53.2 ± 13.7 | 53.2 ± 14.5 | 53.2 ± 14.0 |
| Sex/Gender, Customized(Participants) | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) | Total |
|---|---|---|---|
| Male | 78 | 51 | 129 |
| Female | 56 | 39 | 95 |
| Prefer Not To Answer | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) | Total |
|---|---|---|---|
| White | 45 | 35 | 80 |
| African American | 61 | 37 | 98 |
| Hispanic / Latino | 16 | 10 | 26 |
| Other | 12 | 9 | 21 |
| Current Relationship Status(Participants) | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) | Total |
|---|---|---|---|
| Single / Not in a Relationship | 49 | 23 | 72 |
| Married / In Civil Union / Living Together | 75 | 62 | 137 |
| Not Married / Not in Civil Union / Living Apart | 10 | 6 | 16 |
| Education(Participants) | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Enhanced Usual Care (EUC) | Total |
|---|---|---|---|
| <High School / HS / Vocational School | 16 | 13 | 29 |
| Some College | 30 | 29 | 59 |
| Associate Degree | 23 | 13 | 36 |
| Bachelor's Degree | 30 | 20 | 50 |
| Graduate Degree | 35 | 16 | 51 |
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VA Office of Research and Development