Brief Cognitive Behavioral Therapy for Anxiety

NCT03820973 | Completed

• 1 other identifier: H-44258
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

brief Cognitive Behavioral Therapy; VA Video Connect to home

Outcome Measures

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.

  Baseline, and 3-Months

Study Arms (1)

Brief CBT for Anxiety

EXPERIMENTAL

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

Brief CBT for Anxiety BEHAVIORAL

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.

Brief CBT for Anxiety

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran participants: The sample will include Veterans who:
• receive care at the Houston VA and surrounding area CBOCs,
• have documentation in the medical chart of an anxiety disorder or anxiety-related problems, and
• report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7).

You may not qualify if:

• Veteran participants will be excluded for factors that would render bCBT inappropriate, including:
• cognitive impairment;
• presence of bipolar, psychotic or substance use disorders, and
• Veteran is currently receiving psychotherapy for anxiety. If receiving medications that target anxiety Veterans WILL NOT be excluded.

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead

Study Sites (1)

Michael E. DeBakey VAMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jeffrey Cully, PhD

  Michael E. DeBakey VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinicial Research Psychologist

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)