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CompletedNCT03820973Updated Apr 22, 2022

Brief Cognitive Behavioral Therapy for Anxiety

An interventional study of Brief CBT for Anxiety in Anxiety, sponsored by Michael E. DeBakey VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-04-22.

Sponsored by Michael E. DeBakey VA Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The proposed clinical intervention is a modular skills-based intervention for flexible delivery of care, measurement-based care practices, and integration of exposure strategies critical for anxiety symptom reduction. Notably, the treatment targets anxiety symptoms rather than diagnoses to improve use in PCMHI and CBOC settings. The pilot study will develop and conduct preliminary testing of bCBT for anxiety using Veterans Affairs (VA) Video Connect to Home (VVC-H) to deliver care.

Read the detailed description

Anxiety disorders are identified in over 30% of primary care patients and are associated with substantial functional impairment, poor health-related quality of life, and suicide; however, rates of treatment are low. In contrast to advances in improving treatment of depression and posttraumatic stress disorder in VA, far less attention has been given to anxiety disorders. In the absence of VA clinical practice guidelines for anxiety disorders, evidence-based treatment practices are unstandardized in VA primary care and Community Based Outpatient Clinics (CBOCs). Cognitive behavioral therapy (CBT) is an evidence-based intervention for the anxiety disorders but was developed for use in specialty mental health settings and often targets individual anxiety disorders (e.g.generalized anxiety, panic, and social phobia) with diagnosis-specific treatment packages. These interventions are not practical for primary care and CBOC settings where treatment must be brief and focused on reduction of anxiety symptoms rather than targeted anxiety diagnoses. Further complicating the delivery of CBT for anxiety disorders is that repeated exposure to feared cues is considered a critical component of CBT for anxiety but is rarely used in these settings. Providers within VA currently have no standardized options for delivering brief evidence-based psychotherapy for Veterans with anxiety. Although Primary Care Mental Health Integration (PCMHI) and CBOCs increase access to mental health services, VA recognizes the need to deliver mental health services using video to home technology to increase access, decrease barriers (i.e., geographic distance, transportation, travel time, stigma, child care) and provide more Veteran-centric care. VA is pioneering implementation of VA Video Connect to Home (VVC-H) technology in specialty mental health clinics, but VVC-H continues to be rarely used and little is known about the implementation potential of VVC-H to improve psychotherapy access and outcomes in primary care and CBOC settings. In summary, VA needs a flexible evidence-based approach for anxiety that fits within primary care and CBOC settings and offers innovative delivery strategies to increase access to care. Although treatment in PCMHI and CBOC settings must be time-limited, it must also be highly effective. The investigators have developed robust brief CBT (bCBT) interventions and provider support programs for depression and is now seeking to address anxiety using a similar approach. The proposed clinical intervention will use state-of-the-art practices including delivery of services via VVC-H. This open trial seeks to recruit 12 Veterans who have significant anxiety symptoms according to the GAD-7 (standard assessment tool for VA clinical settings). Veterans will be recruited from the Michael E. DeBakey VAMC primary care clinic and affiliated Community Based Outpatient Clinics (CBOCs).

02

Conditions studied

  • Anxiety

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Keywords

  • brief Cognitive Behavioral Therapy
  • VA Video Connect to home
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 18 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Veteran participants: The sample will include Veterans who:

  1. receive care at the Houston VA and surrounding area CBOCs,
  2. have documentation in the medical chart of an anxiety disorder or anxiety-related problems, and
  3. report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7).

Exclusion criteria

Exclusion Criteria:

Veteran participants will be excluded for factors that would render bCBT inappropriate, including:

  1. cognitive impairment;
  2. presence of bipolar, psychotic or substance use disorders, and
  3. Veteran is currently receiving psychotherapy for anxiety. If receiving medications that target anxiety Veterans WILL NOT be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Brief CBT for Anxiety

    Participants will receive Brief Cognitive Behavioral Therapy for Anxiety (bCBT). Sessions with clinicians will be provided via VA Video Connect to Home (VVC-H). Participants will have the option to select from a list of skills to tailor to his/her preferences. Participants will be able to receive up to 9 total sessions and generally last 30 to 40 minutes. For the purpose of this study, treatment duration will be limited to 3 months to ensure standardization of study outcome measures.

    Behavioral: Brief CBT for Anxiety

Interventions

  • BehavioralBrief CBT for Anxiety

    All participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts.

06

What researchers measure

Primary outcomes

  1. Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time

    scale used to measure anxiety, scores range from 0 to 21, where higher scores equal higher levels of anxiety.

    Time frame: Baseline, and 3-Months

07

Study locations

1 site
  • Michael E. DeBakey VAMC
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03820973
Lead sponsor
Michael E. DeBakey VA Medical Center
Responsible party
Jeffrey Cully (Clinicial Research Psychologist, Michael E. DeBakey VA Medical Center) — Principal investigator
First posted
Jan 29, 2019
Start date
Feb 1, 2019
Primary completion
Jul 1, 2021
Completion
Sep 1, 2021
Last update
Apr 22, 2022

Study contacts

Jeffrey Cully, PhD
principal investigator · Michael E. DeBakey VAMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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