Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Change in Anxiety Sensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will occur as this is a one-arm trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Change in Anxiety Sensitivity
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Mean Changes in Anxiety(From baseline to follow-up (measured six weeks after intervention session))
- Mean Changes in Worry Related to the COVID-19 Pandemic(From baseline to follow-up (measured six weeks after intervention session))
- Mean Changes in Avoidance Due to the COVID-19 Pandemic(From baseline to follow-up (measured six weeks after intervention session))
- Mean Changes in Functional Impairment Due to the COVID-19 Pandemic(From baseline to follow-up (measured six weeks after intervention session))
- Mean Change in Depression(From baseline to follow-up (measured six weeks after intervention session))