Trial Outcomes & Findings for BEAST: A Pilot Trial (NCT NCT05416203)

Last Updated: 2025-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

From baseline to post-intervention (two-weeks after virtual treatment session)

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	BEAST Condition 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. Brief Enhanced Anxiety Sensitivity Treatment: 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.
Overall Study STARTED	15
Overall Study Completed Intervention	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BEAST: A Pilot Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BEAST Condition n=15 Participants 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. Brief Enhanced Anxiety Sensitivity Treatment: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55.87 years STANDARD_DEVIATION 5.91 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
Marital Status Single/Never Married	4 Participants n=5 Participants
Marital Status Divorced/Separated	4 Participants n=5 Participants
Marital Status Married or Living with Partner	7 Participants n=5 Participants
Education High School Diploma	3 Participants n=5 Participants
Education Associates/Technical	3 Participants n=5 Participants
Education Four-Year College	3 Participants n=5 Participants
Education Master's Degree	5 Participants n=5 Participants
Education Professional Degree	1 Participants n=5 Participants
Served During Gulf War Served during Gulf War	6 Participants n=5 Participants
Served During Gulf War Did not Serve during Gulf War	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to post-intervention (two-weeks after virtual treatment session)

Outcome measures

Outcome measures
Measure	BEAST Condition n=13 Participants 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. Brief Enhanced Anxiety Sensitivity Treatment: 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.
Mean Change in Anxiety Sensitivity	-11.15 score on a scale Standard Deviation 13.89

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BEAST Condition n=13 Participants 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. Brief Enhanced Anxiety Sensitivity Treatment: 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.
Program Satisfaction	3.95 score on a scale Standard Deviation .77

PRIMARY outcome

Timeframe: 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.