BEAST: A Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study

Conditions
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Anxiety Sensitivity, Functional Impairment

Intervention / Treatment
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* Behavioral: Brief Enhanced Anxiety Sensitivity Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEAST Condition<br>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. | Behavioral: Brief Enhanced Anxiety Sensitivity Treatment<br>* 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.<br>* Other names: BEAST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety