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BEAST: A Pilot Trial (BEAST)

Primary Purpose

Anxiety Sensitivity, Functional Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Enhanced Anxiety Sensitivity Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Sensitivity focused on measuring Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Finger Lakes Healthcare System, Canandaigua, NYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BEAST Condition

Arm 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.

Outcomes

Primary Outcome Measures

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.
Program satisfaction
Program satisfaction will be measured using the Program Satisfaction Questionnaire, a 14-item measure that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Scores range from 14 to 70 with higher scores indicating greater satisfaction.
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.

Secondary Outcome Measures

Mean changes in anxiety
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.
Mean changes in worry related to the COVID-19 pandemic
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.
Mean changes in avoidance due to the COVID-19 pandemic
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.
Mean changes in functional impairment due to the COVID-19 pandemic
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.
Mean change in depression
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.

Full Information

First Posted
June 8, 2022
Last Updated
August 10, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05416203
Brief Title
BEAST: A Pilot Trial
Acronym
BEAST
Official Title
Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity, Functional Impairment
Keywords
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
Masking
None (Open Label)
Masking Description
No masking will occur as this is a one-arm trial.
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BEAST Condition
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Enhanced Anxiety Sensitivity Treatment
Other Intervention Name(s)
BEAST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in anxiety sensitivity
Description
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.
Time Frame
From baseline to post-intervention (two-weeks after virtual treatment session)
Title
Program satisfaction
Description
Program satisfaction will be measured using the Program Satisfaction Questionnaire, a 14-item measure that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Scores range from 14 to 70 with higher scores indicating greater satisfaction.
Time Frame
Post-intervention (two weeks after virtual treatment session)
Title
Mean change in Functional impairment
Description
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.
Time Frame
From baseline to post-intervention (two-weeks after virtual treatment session)
Secondary Outcome Measure Information:
Title
Mean changes in anxiety
Description
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.
Time Frame
From baseline to follow-up (measured six weeks after intervention session)
Title
Mean changes in worry related to the COVID-19 pandemic
Description
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.
Time Frame
From baseline to follow-up (measured six weeks after intervention session)
Title
Mean changes in avoidance due to the COVID-19 pandemic
Description
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.
Time Frame
From baseline to follow-up (measured six weeks after intervention session)
Title
Mean changes in functional impairment due to the COVID-19 pandemic
Description
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.
Time Frame
From baseline to follow-up (measured six weeks after intervention session)
Title
Mean change in depression
Description
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.
Time Frame
From baseline to follow-up (measured six weeks after intervention session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas P Allan, PhD
Phone
(850) 274-0567
Email
nicholas.allan@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Park M Bogan, BA
Phone
(808) 379-5683
Email
park.bogan@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas P Allan, PhD
Organizational Affiliation
VA Finger Lakes Healthcare System, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Finger Lakes Healthcare System, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424-1159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather M Hall
Phone
315-425-4400
Ext
52878
Email
Heather.Hall3@va.gov
First Name & Middle Initial & Last Name & Degree
Nicholas P Allan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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BEAST: A Pilot Trial

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