BEAST: A Pilot Trial

Functional Impairment Clinical Trial

— BEAST  

Official title:

Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416203
• Other study ID #: D3880-P
• Secondary ID: I02RX003880
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Nicholas P Allan, PhD
• Phone: (850) 274-0567
• Email: nicholas.allan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT05490199

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Sensitivity
• Functional Impairment
• Hypersensitivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Finger Lakes Healthcare System, Canandaigua, NY	Canandaigua	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to post-intervention (two-weeks after virtual treatment session)
Primary	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.	Post-intervention (two weeks after virtual treatment session)
Primary	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.	From baseline to post-intervention (two-weeks after virtual treatment session)
Secondary	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.	From baseline to follow-up (measured six weeks after intervention session)
Secondary	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.	From baseline to follow-up (measured six weeks after intervention session)
Secondary	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.	From baseline to follow-up (measured six weeks after intervention session)
Secondary	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.	From baseline to follow-up (measured six weeks after intervention session)
Secondary	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.	From baseline to follow-up (measured six weeks after intervention session)