BEAST: A Pilot Trial
- Conditions
- Anxiety SensitivityFunctional Impairment
- Interventions
- Behavioral: Brief Enhanced Anxiety Sensitivity Treatment
- Registration Number
- NCT05416203
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BEAST Condition Brief Enhanced Anxiety Sensitivity Treatment 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.
- Primary Outcome Measures
Name Time Method Mean change in anxiety sensitivity 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.
Mean change in Functional impairment 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.
Program satisfaction Post-intervention (two weeks after virtual treatment session) 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.
- Secondary Outcome Measures
Name Time Method Mean changes in anxiety 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.
Mean changes in worry related to the COVID-19 pandemic 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.
Mean changes in avoidance due to the COVID-19 pandemic 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.
Mean changes in functional impairment due to the COVID-19 pandemic 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.
Mean change in depression 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.
Trial Locations
- Locations (1)
VA Finger Lakes Healthcare System, Canandaigua, NY
🇺🇸Canandaigua, New York, United States