Anxiety Clinical Trial - A Pragmatic Trial of Brief CBT for Anxiety in VA

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This 4-year, 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04523779
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 3, 2022
Completion date	May 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Pragmatic Trial of Brief CBT for Anxiety in VA Primary Care

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms