BEAST: A Pilot Trial

NCT ID: NCT05416203

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-08-30

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.

Detailed Description

This study tests a treatment with two components: first, there is a single session face-to-face virtual intervention delivered by the counselor or therapist via VA Video Connect software. Second, a mobile app (mPRO) is used for EMA and to deliver EMI components.

Veterans will be enrolled following informed consent. The research staff will read the measures to the Veteran who will verbally provide their answers.

Veterans will next complete the baseline assessment. At the baseline assessment, Veterans meet with the Project Coordinator by phone or virtually to complete a consenting process, guidance on the video software being used, and set-up and guidance on use of the mobile app.

Following the baseline assessment, participants will be scheduled to receive the face-to-face virtual intervention followed by two weeks of EMA/EMI via mPRO.

At the end of the two weeks, Veterans will complete a post-intervention assessment appointment. The post-intervention assessment includes an exit interview for participants to provide additional feedback regarding acceptability of the intervention.

Follow-up assessment appointments will be completed at the 1-month and 3-month follow-ups.

Conditions

Anxiety Sensitivity; Functional Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BEAST Condition

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.

Group Type: EXPERIMENTAL

Brief Enhanced Anxiety Sensitivity Treatment

Intervention Type: 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.

Interventions

Brief Enhanced Anxiety Sensitivity Treatment

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BEAST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas P Allan, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Finger Lakes Healthcare System, Canandaigua, NY

Locations

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

I02RX003880

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D3880-P

Identifier Type: -

Identifier Source: org_study_id

NCT05490199

Identifier Type: -

Identifier Source: nct_alias