EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
2026년 9월 15일 업데이트: Yinyin Zang, PhD, Peking University
Ecological Momentary Intervention for Reducing Psychological Distress in Young Adults With Multiple Adverse Childhood Experiences: A Feasibility Study
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.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yinyin Zang
- 전화번호: 010-62756953
- 이메일: Yinyin.Zang@pku.edu.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
The ecological momentary intervention (EMI) is a 2-week smartphone-based intervention delivered in participants' daily lives. At the beginning of the intervention, participants will watch an approximately 10-minute psychoeducational video introducing the psychological principles underlying the intervention and the purposes of the exercises. They will then receive instructions on how to use the EMI program. During the intervention period, participants will receive brief ecological momentary assessments (EMAs) assessing their current emotional state. Based on their reported emotional valence, the program will provide tailored intervention content. When participants report negative or neutral emotional states (emotional valence ≤ 0), they will receive a negative-emotion module. This module includes brief breathing and grounding exercises, identification and labeling of current emotions, identification of potentially catastrophic or negative self-referential thoughts, cognitive reapprais |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Enrollment Rate Among Eligible Participants
기간: 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.
|
Through completion of recruitment, up to 3 weeks
|
|
Proportion of Eligible Participants
기간: 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.
|
Through completion of recruitment, up to 3 weeks
|
|
Intervention Engagement
기간: 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.
|
Throughout the 2-week intervention
|
|
Study Retention Rate
기간: Immediately post-treatment
|
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.
|
Immediately post-treatment
|
|
Intervention acceptability
기간: 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.
|
Immediately post-treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Psychological Distress
기간: Baseline and immediately post-treatment
|
Psychological distress will be assessed using the 6-item Kessler Psychological Distress Scale (K6).
Each item is rated on a 5-point frequency scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 24, with higher scores indicating greater psychological distress.
|
Baseline and immediately post-treatment
|
|
Catastrophizing
기간: Baseline and immediately post-treatment
|
Catastrophizing will be assessed using the catastrophizing subscale of the 18-item Cognitive Emotion Regulation Questionnaire (CERQ-18).
The CERQ-18 consists of nine 2-item subscales.
Each item is rated on a 5-point scale from 1 to 5. The two catastrophizing items are summed to produce a subscale score ranging from 2 to 10, with higher scores indicating more frequent use of catastrophizing as a cognitive emotion regulation strategy.
|
Baseline and immediately post-treatment
|
|
Self-Esteem
기간: Baseline and immediately post-treatment
|
Global self-esteem will be assessed using the 10-item Rosenberg Self-Esteem Scale (RSES).
Each item is rated on a 4-point scale from 1 to 4, with negatively worded items reverse-scored.
Item scores are summed to produce a total score ranging from 10 to 40, with higher scores indicating higher levels of global self-esteem.
|
Baseline and immediately post-treatment
|
|
Emotional clarity
기간: Baseline and immediately post-treatment
|
Emotional clarity will be assessed using the Lack of Emotional Clarity subscale of the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF).
The subscale consists of two items, each rated on a 5-point scale from 1 to 5. Item scores are summed to yield a total score ranging from 2 to 10, with higher scores indicating greater difficulties in emotional clarity.
|
Baseline and immediately post-treatment
|
|
Depressive Symptoms
기간: Baseline and immediately post-treatment
|
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day).
Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
|
Baseline and immediately post-treatment
|
|
Anxiety Symptoms
기간: Baseline and immediately post-treatment
|
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7).
Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day).
Item scores are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
|
Baseline and immediately post-treatment
|
|
Eating Disorder Symptoms
기간: Baseline and immediately post-treatment
|
Eating disorder symptoms will be assessed using the 12-item Eating Disorder Examination Questionnaire-Short Form (EDE-QS).
Each item is scored from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 36, with higher scores indicating greater severity of eating disorder symptoms.
|
Baseline and immediately post-treatment
|
|
Insomnia Severity
기간: Baseline and immediately post-treatment
|
Insomnia symptoms will be assessed using the 7-item Insomnia Severity Index (ISI).
Each item is rated on a 5-point scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.
|
Baseline and immediately post-treatment
|
|
Somatic Symptom Severity
기간: Baseline and immediately post-treatment
|
Somatic symptoms will be assessed using the 15-item Patient Health Questionnaire (PHQ-15).
Each item is rated on a 3-point scale from 0 (not bothered at all) to 2 (bothered a lot).
Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater somatic symptom severity.
|
Baseline and immediately post-treatment
|
|
Suicidal Ideation
기간: Baseline and immediately post-treatment
|
Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation (BSS).
The BSS contains 21 items; the first 19 items assess the severity of current suicidal ideation and are scored from 0 to 2. These 19 items are summed to produce a total score ranging from 0 to 38, with higher scores indicating greater severity of suicidal ideation.
The remaining two items assess previous suicide attempts and are not included in the total severity score.
|
Baseline and immediately post-treatment
|
|
Self-Harm Severity
기간: Baseline and immediately post-treatment
|
Self-harm will be assessed using a study-developed self-report questionnaire assessing the severity of self-harm behaviors.
|
Baseline and immediately post-treatment
|
|
Urgency
기간: Baseline and immediately post-treatment
|
Negative and positive urgency will be assessed using the Negative Urgency and Positive Urgency subscale of the Short UPPS-P Impulsive Behavior Scale (SUPPS-P), respectively.
Each subscale contains 4 items rated on a 4-point scale from 1 to 4. After appropriate reverse scoring, the four items are summed to produce a score ranging from 4 to 16, with higher scores indicating a greater tendency to act impulsively when experiencing intense emotions.
|
Baseline and immediately post-treatment
|
|
Functional Impairment
기간: Baseline and immediately post-treatment
|
Functional impairment will be assessed using the Sheehan Disability Scale (SDS).
The scale contains 3 items assessing impairment in work or school, social life, and family life or home responsibilities.
Each item is rated from 0 to 10.
The three items are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater functional impairment.
|
Baseline and immediately post-treatment
|
|
Life Satisfaction
기간: Baseline and immediately post-treatment
|
Life satisfaction will be assessed using the 5-item Satisfaction With Life Scale (SWLS).
Each item is rated on a 7-point scale from 1 to 7. Item scores are summed to produce a total score ranging from 5 to 35, with higher scores indicating greater satisfaction with life.
|
Baseline and immediately post-treatment
|
|
Self-Compassion
기간: Baseline and immediately post-treatment
|
Self-compassion will be assessed using the 12-item Self-Compassion Scale-Short Form (SCS-SF).
Each item is rated on a 5-point scale from 1 (almost never) to 5 (almost always).
Negatively worded items are reverse-scored, and an overall mean score ranging from 1 to 5 is calculated, with higher scores indicating greater self-compassion.
|
Baseline and immediately post-treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 7일
기본 완료 (추정된)
2026년 10월 11일
연구 완료 (추정된)
2026년 10월 11일
연구 등록 날짜
최초 제출
2026년 9월 4일
QC 기준을 충족하는 최초 제출
2026년 9월 15일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EMI for high ACEs
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .