Clinical trial NCT05416203: BEAST: A Pilot Trial
Official title: Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Sensitivity
Functional Impairment
Keywords: Anxiety
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change in Anxiety Sensitivity
timeFrame: From baseline to post-intervention (two-weeks after virtual treatment session)
measure: Program Satisfaction
timeFrame: Post-intervention (two weeks after virtual treatment session)
measure: Mean Change in Functional Impairment
timeFrame: From baseline to post-intervention (two-weeks after virtual treatment session)
Secondary outcomes:
measure: Mean Changes in Anxiety
timeFrame: From baseline to follow-up (measured six weeks after intervention session)
measure: Mean Changes in Worry Related to the COVID-19 Pandemic
timeFrame: From baseline to follow-up (measured six weeks after intervention session)
measure: Mean Changes in Avoidance Due to the COVID-19 Pandemic
timeFrame: From baseline to follow-up (measured six weeks after intervention session)
measure: Mean Changes in Functional Impairment Due to the COVID-19 Pandemic
timeFrame: From baseline to follow-up (measured six weeks after intervention session)
measure: Mean Change in Depression
timeFrame: From baseline to follow-up (measured six weeks after intervention session)
Other outcomes:
Locations:
city: Canandaigua
country: United States
facility: VA Finger Lakes Healthcare System, Canandaigua, NY
state: New York
Study officials:
affiliation: VA Finger Lakes Healthcare System, Canandaigua, NY
name: Nicholas P Allan, PhD
role: PRINCIPAL_INVESTIGATOR
References: