Intervention Based on Acceptance and Commitment Therapy Enhanced With Virtual Reality for Older Adults With Anxiety Symptoms: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Intervention adherence
研究概览
简要总结
The goal of this pilot RCT is to develop, implement and evaluate an Intervention Program based on Acceptance and Commitment Therapy using virtual reality as one of the components, in a sample of individuals aged 65 or older with anxiety symptoms enrolled in Portuguese day centers, with the aim of evaluating the feasibility, acceptability and preliminary evidence of efficacy of the intervention program and exploring the attitudes, behaviors and perceived barriers on the part of the participants towards the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 65 or older;
- •Participants with mild, moderate, or severe anxiety symptoms;
- •Participants who attend day centers.
排除标准
- •Participants with a medical diagnosis of neurocognitive disorder or with significant cognitive deficits (measured with Mini-Mental State Examination);
- •Participants with illiteracy or with linguistic difficulties that hinder communication and the comprehension of instructions;
- •Participants with reduced visual acuity.
结局指标
主要结局
Intervention adherence
时间窗: Throughout the intervention period (6 weeks)
Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme
Acceptability and feasibility of the intervention assessed by TFA
时间窗: Post-intervention (at week 7)
Acceptability and feasibility assessed with the theoretical framework of acceptability questionnaire (TFA). Items are rated on a 5-point Likert scale ranging from 1 to 5. Scores range from 7 to 35, and a higher score corresponds to greater acceptability and feasibility.
Acceptability and perceived barriers (semi-structured interviews)
时间窗: Post-intervention (at week 7)
Individual semi-structured interviews conducted after intervention completion to explore participants' experiences, satisfaction, perceived benefits, barriers to engagement, and suggestions for improvement
次要结局
- Anxiety symptoms(Baseline, post-intervention (week 7) and follow-up (3 months))
- Psychological flexibility(Baseline, post-intervention (week 7) and follow-up (3 months))
- Self-compassion(Baseline, post-intervention (week 7) and follow-up (3 months))
研究者
Marta Barata
PhD Student
Grupo Lusófona