N/A
N=225
A Pragmatic Trial of Brief CBT for Anxiety in VA Primary Care
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04523779 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: General Anxiety Disorder-7 (GAD-7) — 15.4; 14.7; 11.6; 12.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Cognitive Behavioral Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY General Anxiety Disorder-7 (GAD-7) |
15.4; 14.7; 11.6; 12.0; 10.9; 11.9 | — |
| SECONDARY Overall Anxiety Severity and Impairment Scale (OASIS) |
11.6; 11.0; 9.6; 9.7; 10.2; 10.0 | — |
| SECONDARY Short Form-12 Physical Component Summary (SF-12-PCS) |
39.9; 42.2; 38.5; 39.8; 36.6; 39.0 | — |
| SECONDARY Short Form-12 Mental Component Summary (SF12-MCS) |
35.6; 35.6; 38.9; 37.4; 38.4; 36.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Must be a United States military Veteran
- Veteran participants will be current recipients of services at the Houston, New Orleans, or San Antonio VA Medical Centers.
- Patients who have received Primary Care Mental Health Integration services, or are eligible for PCMHI services (They are not receiving specialty mental health services)
- Veterans with clinically significant symptoms of anxiety will be included after screening on two occasions to ensure consistency of anxiety symptoms (GAD-7 score of 10 or greater; telephone screen and baseline appointment).
Exclusion Criteria
- Cognitive impairment
- Presence of bipolar, psychotic or substance-abuse disorders.
- Veterans currently receiving psychotherapy for anxiety at the time of enrollment will be excluded so as not to duplicate services (Current treatment will be defined as patients that have received a psychotherapy appointment within the last 3 months).
Data sourced from ClinicalTrials.gov (NCT04523779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.