BEAST: A Pilot Trial

NCT05416203 | Completed Results

• 2 other identifiers: D3880-PI02RX003880
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study trial will test the acceptability, feasibility, and usability of a brief enhanced anxiety sensitivity treatment to reduce anxiety sensitivity and functional impairment in Veterans.

Conditions

Anxiety Sensitivity; Functional Impairment

Keywords

Anxiety

Outcome Measures

Primary Outcomes (3)

• Mean Change in Anxiety Sensitivity

  Anxiety sensitivity will be measured via the Anxiety Sensitivity Index-3, an 18-item self-report measure assessing fear of negative consequences of anxiety-related symptoms. Scores range from 0 to 72 with higher scores indicating worse anxiety sensitivity.

  From baseline to post-intervention (two-weeks after virtual treatment session)

• Program Satisfaction

  Program satisfaction will be measured using an adapted 11-item version of the Program Satisfaction Questionnaire that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Average scores range from 1 to 5 with higher scores indicating greater satisfaction.

  Post-intervention (two weeks after virtual treatment session)

• Mean Change in Functional Impairment

  Functional impairment will be measured using the 12-item version of the World Health Organization Disability Assessment 2.0. This scale assesses functional impairment across six domains: 1) understanding and communication, 2) self-care, 3) mobility, 4) interpersonal relationships, 5) work and household roles, and 6) community and civic roles. Scores range from 0 to 48 with higher scores indicating worse functional impairment.

  From baseline to post-intervention (two-weeks after virtual treatment session)

Secondary Outcomes (5)

• Mean Changes in Anxiety

  From baseline to follow-up (measured six weeks after intervention session)

• Mean Changes in Worry Related to the COVID-19 Pandemic

  From baseline to follow-up (measured six weeks after intervention session)

• Mean Changes in Avoidance Due to the COVID-19 Pandemic

  From baseline to follow-up (measured six weeks after intervention session)

• Mean Changes in Functional Impairment Due to the COVID-19 Pandemic

  From baseline to follow-up (measured six weeks after intervention session)

• Mean Change in Depression

  From baseline to follow-up (measured six weeks after intervention session)

Study Arms (1)

BEAST Condition

EXPERIMENTAL

A one-session intervention that can be delivered effectively by a clinician via telehealth and supplemented with a mobile app to provide opportunities to practice the skills learned in the face-to-face session.

Behavioral: Brief Enhanced Anxiety Sensitivity Treatment

Interventions

Brief Enhanced Anxiety Sensitivity Treatment BEHAVIORAL

BEAST is a CBT-based intervention that includes psychoeducation, identifying and challenging maladaptive thoughts, and interoceptive exposure. The intervention is delivered through a single virtual face-to-face session supplemented with a mobile app for two weeks after the face to face session.

Also known as: BEAST

BEAST Condition

Eligibility Criteria

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

You may qualify if:

• Are English-speaking
• Score equal to or greater than 9 on the SSASI indicating elevated anxiety sensitivity
• Score equal to or greater than 5 on the WHODAS 2.0

You may not qualify if:

• Veterans with cognitive impairment as measured scoring equal to or greater than 11 on the Blessed
• Orientation-Memory-Concentration Test
• Veterans without access to a smartphone
• Veterans with significant medical or psychiatric conditions that may limit participation, including:
• severe documented schizophrenia
• an ongoing active psychotic or manic state
• an imminent suicide crisis will be excluded from our study and provided the appropriate referral

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Nicholas Allan
• Organization: Department of Veteran Affairs

nicholas.allan@va.gov

8502740567

Study Officials

• Nicholas P Allan, PhD

  VA Finger Lakes Healthcare System, Canandaigua, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will occur as this is a one-arm trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: August 30, 2024
• Last Updated: July 1, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)