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

NCT04523779 | Completed Results DMC

• 3 other identifiers: IIR 18-233HX-002796CIRB 20-22
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Anxiety

Keywords

anxiety disorder; panic disorder; phobia, social; worry; stress

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4-, 8-, and 12-month

Secondary Outcomes (3)

• Overall Anxiety Severity and Impairment Scale (OASIS)

  Baseline, 4-, 8-, and 12-month

• Short Form-12 Physical Component Summary (SF-12-PCS)

  Baseline, 4-, 8-, and 12-month

• Short Form-12 Mental Component Summary (SF12-MCS)

  Baseline, 4-, 8-, 12-month

Study Arms (2)

Brief Cognitive Behavioral Therapy

EXPERIMENTAL

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

Enhanced Usual Care

NO INTERVENTION

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).

Interventions

Brief Cognitive Behavioral Therapy BEHAVIORAL

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

Brief Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• Cully JA, Fischer EP, Gonzalez R, Williams JS, Sansgiry S, Zeno D, Mittal D, Kuo I. Provider perceptions and use of mental health services in the Veterans Health Administration during the COVID-19 pandemic. Psychol Serv. 2024 Feb;21(1):110-119. doi: 10.1037/ser0000772. Epub 2023 Jun 1.

  PMID: 37261762 BACKGROUND

• Ecker AH, Cully JA, Cucciare MA, Hundt NE. Patient and Provider Perspectives on Treating Substance Use Disorder and Co-Occurring Anxiety and Posttraumatic Stress Disorders in the Veterans Affairs Healthcare System. Journal of Veterans Studies. 2023 Jun 1; 9(1):171-180.

  BACKGROUND

• Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7.

  PMID: 37674395 BACKGROUND

• Hertz AG, Dawson DB, Rassu FS, Ecker AH, Helm A, Hundt NE, Fletcher TL. Delivery of Exposure and Response Prevention Among Veterans with Obsessive-Compulsive Disorder. J Behav Health Serv Res. 2023 Oct;50(4):514-523. doi: 10.1007/s11414-023-09838-3. Epub 2023 Apr 6.

  PMID: 37024645 BACKGROUND

• Boykin DM, Wray LO, Funderburk JS, Holliday S, Kunik ME, Kauth MR, Fletcher TL, Mignogna J, Roberson RB 3rd, Cully JA. Leveraging the ExpandNet framework and operational partnerships to scale-up brief Cognitive Behavioral Therapy in VA primary care clinics. J Clin Transl Sci. 2022 Jul 20;6(1):e95. doi: 10.1017/cts.2022.430. eCollection 2022.

  PMID: 36003211 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Limitations and Caveats

This study was conducted during the COVID-19 pandemic, which may limit the interpretation and generalizability of findings.

Results Point of Contact

• Title: Terri L. Fletcher, PhD
• Organization: Michael E. DeBakey VA Medical Center, Houston, TX

Terri.Fletcher@VA.gov

713-440-4490

Study Officials

• Terri L. Fletcher, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome data will be collected by independent evaluators (IEs) who will be blinded to randomization. All IEs will be based in Houston, with direct oversight by Dr. Cully. IEs will undergo training and calibration on all study measures and be regularly reassessed for quality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cognitive behavioral therapy (CBT) is an evidence-based practice (EBP) for all types of anxiety disorders including generalized anxiety disorder (GAD), panic disorder, and social anxiety disorder. 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: January 3, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)