Anxiety SensitivityBEASTNCT05416203
BEAST: A Pilot Trial
A study testing Brief Enhanced Anxiety Sensitivity Treatment in people with Anxiety Sensitivity and Functional Impairment, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Sensitivity, Functional Impairment
- What is being tested?
- Brief Enhanced Anxiety Sensitivity Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Finger Lakes Healthcare System, Canandaigua, NY
Canandaigua, New York, 14424-1159
About this study
Official title: Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
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.
Read the 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.
- Conditions
- Anxiety Sensitivity, Functional Impairment
- Being tested
- Brief Enhanced Anxiety Sensitivity Treatment
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Enhanced Anxiety Sensitivity TreatmentBehavioural
Also called BEAST
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.
| Study group | Role | What they receive |
|---|---|---|
| BEAST Condition | Experimental | 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. Receives: Behavioral: Brief Enhanced Anxiety Sensitivity Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to post-intervention (two-weeks after virtual treatment session)
Program Satisfaction
Program satisfaction will be measured using an adapted 11-item version of the Program Satisfaction Questionnaire that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Average scores range from 1 to 5 with higher scores indicating greater satisfaction.
Measured: 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.
Measured: From baseline to post-intervention (two-weeks after virtual treatment session)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to follow-up (measured six weeks after intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Sep 2022
- Primary completion31 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nicholas P Allan, PhD, Principal investigator, VA Finger Lakes Healthcare System, Canandaigua, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416203
- Sponsor's protocol ID
- D3880-P
- Other IDs
- I02RX003880
- Acronym
- BEAST
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2022
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT05416203
- Acronym / sponsor ID
- BEAST / D3880-P
- Conditions
- Anxiety Sensitivity, Functional Impairment
- Keywords
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
| Arm | Type | Receives |
|---|---|---|
| BEAST Condition | Experimental | Behavioral: Brief Enhanced Anxiety Sensitivity TreatmentA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Enhanced Anxiety Sensitivity TreatmentAlso: BEASTBEAST 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. | Behavioural | BEAST Condition |
Primary outcome
Mean Change in Anxiety Sensitivity
Time frame: 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.
Program Satisfaction
Time frame: Post-intervention (two weeks after virtual treatment session)
Program satisfaction will be measured using an adapted 11-item version of the Program Satisfaction Questionnaire that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Average scores range from 1 to 5 with higher scores indicating greater satisfaction.
Mean Change in Functional Impairment
Time frame: 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.
5 secondary outcomes
Mean Changes in Anxiety
Time frame: From baseline to follow-up (measured six weeks after intervention session)
Mean Changes in Worry Related to the COVID-19 Pandemic
Time frame: From baseline to follow-up (measured six weeks after intervention session)
Mean Changes in Avoidance Due to the COVID-19 Pandemic
Time frame: From baseline to follow-up (measured six weeks after intervention session)
Mean Changes in Functional Impairment Due to the COVID-19 Pandemic
Time frame: From baseline to follow-up (measured six weeks after intervention session)
Mean Change in Depression
Time frame: From baseline to follow-up (measured six weeks after intervention session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas P Allan, PhD principal investigator
VA Finger Lakes Healthcare System, Canandaigua, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Enhanced Anxiety Sensitivity Treatment in people with Anxiety Sensitivity and Functional Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Anxiety Sensitivity (time frame: From baseline to post-intervention (two-weeks after virtual treatment session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.