Brief Enhanced Anxiety Sensitivity Treatment

Overview

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.

Full Title of Study: “Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 28, 2024

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; 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: BEAST Intervention
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Anxiety Sensitivity Index-3 (ASI-3) – assessing change throughout the study
    • Time Frame: Baseline, immediatly post-intervention, one month post-intervention, three month post-intervention
    • 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.
  • Program Satisfaction Questionnaire (PSQ)
    • Time Frame: immediately post-intervention
    • 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.
  • WHO Disability Assessment 2.0 (WHODAS 2.0) – assessing change throughout the study
    • Time Frame: Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
    • 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.

Secondary Measures

  • PROMIS Profile-29 – assessing change throughout the study
    • Time Frame: Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
    • 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).
  • Coronavirus Impact Battery – Worry Scales – assessing change throughout the study
    • Time Frame: Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
    • 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.
  • Coronavirus Impact Battery – Behavior Scales – assessing change throughout the study
    • Time Frame: Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
    • 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.
  • Functional Impairment Due to COVID (FIDC) – assessing change throughout the study
    • Time Frame: Baseline, immediately post-intervention, one month post-intervention, three month post-intervention
    • 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.
  • Anxiety, Depression, Distress Inventory-27 (ADDI-27) – assessing change throughout the study
    • Time Frame: 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
    • This questionnaire measures anxious arousal on a scale of 1 to 5; 1 representing no feelings and 5 representing extreme feelings.
  • Brief Penn State Worry Questionnaire – PSWQ – assessing change throughout the study
    • Time Frame: 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
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Canandaigua VA Medical Center
  • Collaborator
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicholas Allan, PhD, Principal Investigator, VA Fingerlakes Healthcare System
  • Overall Contact(s)
    • Nicholas Allan, PhD, 585-394-2000, nicholas.allan@va.gov

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