Ecological Momentary Intervention for Reducing Psychological Distress in Young Adults With Multiple Adverse Childhood Experiences: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Enrollment Rate Among Eligible Participants
研究概览
简要总结
This single-arm feasibility study aims to evaluate the feasibility and acceptability of an ecological momentary intervention (EMI) designed to reduce psychological distress among young adults with high levels of adverse childhood experiences (ACEs). The intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. Approximately 20 young adults aged 18-29 years who have experienced at least two types of ACEs and report elevated psychological distress will be enrolled. All participants will receive a 2-week smartphone-based EMI delivered in daily life. Feasibility, acceptability, and safety will be evaluated using recruitment, retention, intervention use, participant satisfaction, perceived burden, and adverse events. Changes in psychological distress and related psychological outcomes from baseline to post-intervention will also be explored as exploratory outcomes.
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
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-29 years.
- •History of relatively high exposure to adverse childhood experiences (ACEs), defined as having experienced at least two types of ACEs.
- •Presence of psychological distress, defined as a score of 5 or higher on the 6-item Kessler Psychological Distress Scale (K6).
- •Able to read and understand Chinese fluently.
- •Owns a smartphone with reliable internet access and is able to perform basic smartphone operations.
- •Willing to participate in the study and provide informed consent.
排除标准
- •Current or previous diagnosis of a mental disorder by a psychiatrist.
- •High suicide risk as assessed using the self-report screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
研究组 & 干预措施
EMI intervention
EMI intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. The intervention includes brief ecological momentary assessments and tailored exercises addressing negative and positive emotional experiences.
干预措施: EMI (Behavioral)
结局指标
主要结局
Enrollment Rate Among Eligible Participants
时间窗: Through completion of recruitment, up to 3 weeks
The proportion of eligible individuals who enroll in the study will be calculated as the number of enrolled participants divided by the total number of eligible participants, multiplied by 100.
Proportion of Eligible Participants
时间窗: Through completion of recruitment, up to 3 weeks
The proportion of screened individuals who meet the study eligibility criteria will be calculated as the number of eligible participants divided by the total number of individuals screened, multiplied by 100.
Intervention Engagement
时间窗: Throughout the 2-week intervention
Intervention engagement will be assessed using automatically recorded program-use data, including participants' completion of ecological momentary assessments and intervention exercises during the intervention period. The proportion of delivered intervention opportunities that are completed will be summarized.
Study Retention Rate
时间窗: Immediately post-treatment
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.
Intervention acceptability
时间窗: Immediately post-treatment
Intervention acceptability will be assessed using an adapted version of the Chinese Acceptability of Intervention Measure (cAIM). In addition to the original cAIM items, the adapted measure includes items assessing participants' willingness to recommend the intervention to friends and their willingness to continue using the intervention, informed by Wang et al. (2024). All items are rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived acceptability of the intervention.
次要结局
- Psychological Distress(Baseline and immediately post-treatment)
- Catastrophizing(Baseline and immediately post-treatment)
- Self-Esteem(Baseline and immediately post-treatment)
- Emotional clarity(Baseline and immediately post-treatment)
- Depressive Symptoms(Baseline and immediately post-treatment)
- Self-Harm Severity(Baseline and immediately post-treatment)
- Anxiety Symptoms(Baseline and immediately post-treatment)
- Eating Disorder Symptoms(Baseline and immediately post-treatment)
- Insomnia Severity(Baseline and immediately post-treatment)
- Somatic Symptom Severity(Baseline and immediately post-treatment)
- Suicidal Ideation(Baseline and immediately post-treatment)
- Urgency(Baseline and immediately post-treatment)
- Functional Impairment(Baseline and immediately post-treatment)
- Life Satisfaction(Baseline and immediately post-treatment)
- Self-Compassion(Baseline and immediately post-treatment)
研究者
Yinyin Zang, PhD
Principle Investigator
Peking University