Brief Enhanced Anxiety Sensitivity Treatment

Functional Impairment Clinical Trial

Official title:

Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05490199
• Other study ID #: 1670560
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: May 28, 2024

Study information

• Verified date: April 2022
• Source: Canandaigua VA Medical Center
• Contact: Nicholas Allan, PhD
• Phone: 585-394-2000
• Email: nicholas.allan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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; the investigators have found this improves data reliability and completeness immensely compared to mailing packets/sending survey links.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Participants will include men and women Veterans who:

• Are English-speaking

• Are 18 years of age or older

• Score = 9 on the SSASI indicating elevated anxiety sensitivity

• Score = 5 on the WHODAS 2.0

Exclusion Criteria: Veterans will be excluded on the basis of:

• Veterans with cognitive impairment as measured scoring = 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, or an imminent suicide crisis will be excluded from our study and provided the appropriate referral.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Sensitivity
• Functional Impairment
• Hypersensitivity

Intervention

Behavioral:
• Brief Enhanced Anxiety Sensitivity Treatment (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.

Locations

Country	Name	City	State
United States	VA Fingerlakes Healthcare System	Canandaigua	New York

Sponsors (2)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blessed Orientation Memory Concentration Test (BOMC)	Used to screen for cognitive impairment (i.e., = 11). Participants are asked basic memory tasks and any errors are noted.	Screening
Other	Short Scale Anxiety Sensitivity Index (SSASI) - assessing change throughout the study	The SSASI is a 5-item self-report measure assessing fear of negative consequences of anxiety-related symptoms. Score range from 1 to 5; 1 representing very little concern, 5 representing quite a bit of concern	Daily, from baseline to post-intervention for a total of two weeks, then for one week following one month follow-up and three month follow-up
Other	Intolerance of Uncertainty-12 (IUS-12) - assessing change throughout the study	A 12-item measure assessing uncertainty, ambiguous situations, and the future. The 12 items are rated on a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Other	Depression Symptom Index Suicidality Scale (DSI-SS) - assessing change throughout the study	A 4-item measure assessing suicidality within the previous two weeks. Scoring ranges from 0 to 4, 0 representing no thoughts of suicide, 4 representing severe thoughts of suicide.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Primary	Anxiety Sensitivity Index-3 (ASI-3) - assessing change throughout the study	The ASI-3 is an 18-item self-report measure assessing fear of negative consequences of anxiety-related symptoms. Scoring ranges from 0 (very little) to 5 (very much). Higher scores represent higher anxiety.	Baseline, immediatly post-intervention, one month post-intervention, three month post-intervention
Primary	Program Satisfaction Questionnaire (PSQ)	A 14-item measure that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Scoring ranges from 1 to 5, with lower scores representing disagreement, and high scores representing agreement.	immediately post-intervention
Primary	WHO Disability Assessment 2.0 (WHODAS 2.0) - assessing change throughout the study	The 12-item version of the WHODAS 2.0 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. Scoring ranges from 1 to 5; 1 representing no problems with activity and 5 representing extreme problems with activity.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Secondary	PROMIS Profile-29 - assessing change throughout the study	Used to assess the following domains: anxiety, depression, physical function, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Scoring can range from 1 to 5; lower scores represent no difficulty or experience, while higher scores high difficulty or. Participants will also rate their pain intensity from 0 (no pain) to 10 (worst pain imaginable).	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Secondary	Coronavirus Impact Battery - Worry Scales - assessing change throughout the study	An 11-item scale measuring distress and worry due to the COVID-19 pandemic. Scoring ranges from 0 to 4; 0 representing no worry at all, 4 representing very high levels of worry.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Secondary	Coronavirus Impact Battery - Behavior Scales - assessing change throughout the study	A 12-item scale assessing avoidance behaviors in relation to the COVID-19 pandemic. Scoring ranges from 0 to 4; 0 representing engaging in no behavior, 4 representing actively taking part in behaviors.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Secondary	Functional Impairment Due to COVID (FIDC) - assessing change throughout the study	A 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 4; 0 representing no difficulty in functioning, 4 representing very high difficulty in functioning.	Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
Secondary	Anxiety, Depression, Distress Inventory-27 (ADDI-27) - assessing change throughout the study	This questionnaire measures anxious arousal on a scale of 1 to 5; 1 representing no feelings and 5 representing extreme feelings.	Daily, from baseline to post-intervention for a total of two weeks, then for one week following one month follow-up and three month follow-up
Secondary	Brief Penn State Worry Questionnaire - PSWQ - assessing change throughout the study	This questionnaire measures anxious apprehension on a scale of 1 to 5; 1 representing not being typical of the participants, 5 representing being very typical of the participant.	Daily, from baseline to post-intervention for a total of two weeks, then for one week following one month follow-up and three month follow-up