BEAST: A Pilot Trial

VA Office of Research and Development

Status: Completed

Conditions: Anxiety Sensitivity; Functional Impairment

Treatments: Behavioral: Brief Enhanced Anxiety Sensitivity Treatment

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05416203

D3880-P

I02RX003880 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

BEAST Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Enhanced Anxiety Sensitivity Treatment