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Completed

NCT Number: NCT05416203

BEAST: A Pilot Trial

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.

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Key information

Conditions

Anxiety Sensitivity Anxiety Disorders Functional Impairment Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BEAST

Primary outcomes

  1. Mean Change in Anxiety Sensitivity

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

    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.

  2. Program Satisfaction

    Time frame: Post-intervention (two weeks after virtual treatment session)

    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.

  3. Mean Change in Functional Impairment

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

    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.

Secondary outcomes

  1. Mean Changes in Anxiety

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

    Changes in anxiety will be measured using the 8-item PROMIS anxiety short form. Scores range from 8 to 40 with higher scores indicating worse outcome.

  2. Mean Changes in Worry Related to the COVID-19 Pandemic

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

    Worry related to the pandemic will be measured using the Coronavirus Impact Battery - Worry Scale. This scale is an 11-item scale measuring distress and worry due to the COVID-19 pandemic. Scores range from 0 to 44 with higher scores indicating worse outcome.

  3. Mean Changes in Avoidance Due to the COVID-19 Pandemic

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

    Avoidance due to the pandemic will be measured using the Coronavirus Impact Battery - Behavior Scales, a 12-item scale assessing avoidance behaviors in relation to the COVID-19 pandemic. Scores range from 0 to 48 with higher scores indicating worse outcome.

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

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

    Functional Impairment Due to COVID ScaleA 7-item measure adapted from the WHODAS 2.0 to capture difficulties in functioning due to the COVID-19 pandemic. Scores range from 0 to 28 with higher scores indicating worse outcomes.

  5. Mean Change in Depression

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

    Changes in depression will be measured using the 4-item depression scale from the PROMIS Profile-29. The scores range from 4-20 with higher scores indicating worse outcomes.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study

Acronym: BEAST

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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