跳至主要内容
临床试验/NCT05433662
NCT05433662已完成不适用

Pandemic Acceptance and Commitment Therapy (Pan-ACT): Feasibility and Acceptability of Telehealth Delivery With Older Veterans

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Acceptability of Study Protocol - Retention

研究概览

简要总结

Older adults have been disproportionately impacted and distressed by the novel coronavirus (COVID-19) pandemic. Social distancing and stay-at-home orders have increased older adults' risk of social isolation and loneliness that will has led to a pandemic-induced fear of being in close proximity to other people. These fears and avoidant behaviors will have lasting effects if not treated with effective, safe, and convenient psychological interventions. This study will evaluate the acceptability and feasibility of delivering a small group intervention, called Acceptance and Commitment Therapy (ACT), through a telehealth modality to Veterans ages 60 and older who are experiencing pandemic-related emotional and physical distress. ACT helps decrease emotional suffering, improve well-being and promote positive behavior change by increasing one's psychological flexibility through the practice of mindfulness, acceptance, and values-based behaviors. The knowledge gained from this study will be used to better tailor the invention to meet the needs of older Veterans in an era of post-pandemic recovery.

详细描述

Significance: Accounting for over 80% of COVID-19 related deaths in the United States, adults ages 60 and older have been disproportionately impacted by this pandemic more than any other age group. As a result, they may bear a heavy psychological burden in the months and years to come. Older adults have been labeled "vulnerable" to COVID-19 and strongly encouraged to adhere to "social distancing." This prevention measure is meant to mitigate the spread of the virus but has increased older adults' risk of social isolation and loneliness, which are two known correlates of increased morbidity and mortality in late life. Pandemic-related restrictions have decreased older adults' life-space mobility and negatively affected their physical and nutritional well-being, impairing their quality of life and potentially increasing their vulnerability to poorer outcomes if exposed to COVID-19. Research has documented a plethora of pandemic-related stressors that are common among older adults (e.g., fear of infection, loss of loved ones, financial repercussions) and the culminating psychological impact. Telehealth-adapted evidence-based psychological interventions are needed to address the psychosocial and physical toll of the pandemic among older Veterans. Acceptance and Commitment Therapy (ACT) decreases emotional suffering, improves well-being, promotes and supports healthy behavior changes, and treats a wide range of diagnoses by increasing psychological flexibility through mindfulness, acceptance, and values-based behaviors. Higher psychological flexibility has been associated with pandemic-related coping and well-being. Randomized studies of ACT with older adults are few but promising, and most research studies with this population have used a group format. While research on telehealth delivery of ACT for older adults is limited, preliminary results indicate it is feasible and as effective as ACT delivered in person.

Specific Aim: The proposed study will pilot a 10-session telehealth Pandemic ACT group intervention (i.e., Pan-ACT group) with Veterans ages 60 and older who are experiencing pandemic-related emotional and physical distress.

Methods and Procedures: Twenty-five older Veterans will be enrolled in this single-arm feasibility pilot trial. The intervention will be delivered weekly in 90-minute sessions of groups of four to five Veterans. Feasibility and acceptability of study procedures will be measured by referred-to-enrolled rate, telehealth access and capability, electronic data collection of outcome measures, and qualitative feedback on data collection procedures and measures. Feasibility and acceptability of the intervention will be measured by attendance; attrition; homework completion; participant ratings of the intervention's feasibility, acceptability, and fit; qualitative feedback; and treatment fidelity. Preliminary responsiveness of outcomes measures will be explored. Participants will complete measures of pandemic-related emotional and physical distress, psychological flexibility, depression, anxiety, social connectedness, perceived health, functional impairment, and meaningful engagement at baseline, posttreatment, and one-month follow-up. A brief midpoint assessment at week 5 of the group will consist of measures of social connectedness and functional impairment. Qualitative data will be gathered on perceived efficacy to implement intervention skills and specific emotional or behavioral changes participants have noticed in themselves as a result of the intervention.

Conclusion: The telehealth Pan-ACT Group is a mental and behavioral health rehabilitation intervention that focuses on helping older Veterans develop or recover coping skills that were lost or are no longer effective during the ongoing COVID-19 pandemic. The proposed study address a major research and clinical gap by gathering new knowledge for an urgent need, which will inform the development of a full-scale randomized controlled trial to evaluate the intervention's effectiveness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •receives care at Tuscaloosa VA Medical Center
  • •score of 9 or greater on the COVID-19 Mental Health Impacts Scale
  • •English speaking
  • •provides written informed consent
  • •age 60 or older

排除标准

  • •diagnosis of dementia
  • •score of 31 or less on the Modified Telephone Interview for Cognitive Status
  • •actively suicidal or homicidal
  • •actively psychotic
  • •unstable medical condition
  • •active substance use disorder
  • •currently participating in another cognitive behavioral therapy (CBT) intervention

研究组 & 干预措施

Pandemic Acceptance and Commitment Therapy (Pan-ACT)

Open label assignment to Pan-ACT group telehealth intervention.

干预措施: Pandemic Acceptance and Commitment Therapy (Pan-ACT) (Behavioral)

结局指标

主要结局

Acceptability of Study Protocol - Retention

时间窗: 14 weeks

Retention is defined as number of participants who completed the post-treatment endpoint assessment (numerator) divided by the number of participants who signed informed consent (enrolled; denominator).

Feasibility of Study Protocol - Telehealth Capability

时间窗: 14 weeks

Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.

Acceptability of Intervention - Group Attendance

时间窗: 14 weeks

Percent of participants who started the Pan-ACT intervention (denominator) and attended 70% or more of intervention sessions (numerator)

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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