Image

BEAST: A Pilot Trial

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details

Anxiety Sensitivity, Functional Impairment

NCT05416203

VA Office of Research and Development

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.