Assessing the Feasibility, Acceptability and Effectiveness of an Transdiagnostic Acceptance and Commitment Therapy-based Ecological Momentary Intervention in College Students: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall mental health
研究概览
简要总结
This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.
详细描述
Mental health issues are prevalent among college students, yet traditional interventions often face barriers related to accessibility and engagement. This study explores the feasibility, acceptability, and preliminary effectiveness of a transdiagnostic ACT-based EMI designed to deliver in-the-moment psychological support via digital platforms. A mixed-methods pilot RCT will be conducted, with participants randomly assigned to either the ACT-based EMI group or a mood monitoring group. Quantitative measures will assess changes in psychological flexibility, stress, anxiety, depression, and well-being, while qualitative interviews will provide insights into user experience, engagement, and perceived benefits or barriers. Findings from this study will inform the optimization of ACT-based digital interventions for college students and contribute to the growing field of personalized, technology-assisted mental health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in our study are healthy college students
- •have smartphone, and have access to the internet
排除标准
- •currently participating in another research
- •have significant cognitive impairment that prevents participation in the research
结局指标
主要结局
Overall mental health
时间窗: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Overall mental health will be measured using the 12-item General Health Questionnaire (GHQ-12). Each item is rated on a 4-point Likert scale, with total scores ranging from 0 to 36. Higher scores indicate greater mental health difficulty.
Psychological distress
时间窗: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Psychological distress will be measured using the 21-item Depression Anxiety Stress Scale. They ask about depressive symptoms, anxiety symptoms, and general stress symptoms. Each item is rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more psychological distress
Mental well-being
时间窗: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
The 14-item Mental Health Continuum-Short Form (MHC-SF) will be used to measure mental well-being during the past month. This scale has 3 dimensions: emotional well-being (EWB), psychological well-being (PWB), and social well-being (SWB). Each item is rated on a 6-point scale from 0 (never) to 5 (every day), with a higher score indicating greater well-being.
Psychological flexibility and inflexibility
时间窗: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
The multidimensional psychological flexibility inventory short form (MPFI-24) is a 24-item scale assessing psychological flexibility. The scale consists of a flexibility subscale and an inflexibility subscale, divided into 12 dimensions, with 2 entries for each dimension, a total of 24 entries, and scored at levels 1 (never true) to 6 (always true).
Acceptability
时间窗: post-intervention (one week after baseline)
The 8-item Client Satisfaction Questionnaire (CSQ-8) is employed to measure client satisfaction. Each item is rated on a 4-point Likert scale. Higher scores reflect better client satisfaction.
次要结局
- State anxiety and depression(During the 7-day intervention period, measurements are conducted twice per day.)
- State subjective happiness(During the 7-day intervention period, measurements are conducted twice per day.)
- State stress(During the 7-day intervention period, measurements are conducted twice per day.)
- State psychological inflexibility(During the 7-day intervention period, measurements are conducted twice per day.)
- State suicide ideation(During the 7-day intervention period, measurements are conducted twice per day.)
- State well-being(During the 7-day intervention period, measurements are conducted twice per day.)
- State affect(During the 7-day intervention period, measurements are conducted twice per day.)
- State psychological flexibility(During the 7-day intervention period, measurements are conducted twice per day.)
- Suicide ideation(Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention))