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

• ClinicalTrials.gov Identifier: NCT04523779
• Recruitment Status: Not yet recruiting
• First Posted: August 24, 2020
• Last Update Posted: February 4, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety	Behavioral: Brief Cognitive Behavioral Therapy	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: A Pragmatic Trial of Brief CBT for Anxiety in VA Primary Care
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: April 1, 2023
• Estimated Study Completion Date: April 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Brief Cognitive Behavioral Therapy; 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; 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.; Other Name: bCBT
No Intervention: Enhanced Usual Care; 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).

Outcome Measures

Primary Outcome Measures :

1. GAD-7 Change [ Time Frame: Baseline, 4-, 8-, and 12-month ]
   The GAD-7 is a seven-item self-report instrument for screening, diagnosis and severity assessment of anxiety disorder. 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. Treatment response will be defined as a 50% reduction in baseline GAD-7 scores. 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.

Secondary Outcome Measures :

1. OASIS Change [ Time Frame: Baseline, 4-, 8-, and 12-month ]
   The Overall Anxiety Severity and Impairment Scale (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.
2. SF-12 Change [ Time Frame: Baseline, 4-, 8-, and 12-month ]
   The SF-12 is a self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical and 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 will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF-12V18), 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Veteran participants will be current recipients of services at the Houston, New Orleans, or San Antonio VAMCs.
• 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).

Contacts and Locations

Contacts

Contact: Melia J Wichmann, CCRC BA; (713) 440-4622; melia.wichmann@va.gov

Contact: Terri L Fletcher, PhD; (713) 440-4400; Terri.Fletcher@va.gov

Locations

United States, Texas

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States, 77030

Contact: Melia J Wichmann, CCRC BA 713-440-4622 melia.wichmann@va.gov

Principal Investigator: Terri L. Fletcher, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Terri L. Fletcher, PhD; Michael E. DeBakey VA Medical Center, Houston, TX

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04523779
• Other Study ID Numbers: IIR 18-233
• First Posted: August 24, 2020
• Last Update Posted: February 4, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders