Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT05416203
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2022-06-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BEAST: A Pilot Trial
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAST
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I02RX003880 | OTHER_GRANT | VA RR&D | View |