EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study

NCT07823114 | Not Yet Recruiting

• 1 other identifier: EMI for high ACEs
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Psychological Distress; Adverse Childhood Experience

Outcome Measures

Primary Outcomes (5)

• Enrollment Rate Among Eligible Participants

  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

  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

  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

  Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.

  Immediately post-treatment

• Intervention acceptability

  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

Secondary Outcomes (15)

• 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

Study Arms (1)

EMI intervention

EXPERIMENTAL

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.

Behavioral: EMI

Interventions

EMI BEHAVIORAL

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

EMI intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University: lead

Central Study Contacts

Yinyin Zang

CONTACT

010-62756953; Yinyin.Zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 16, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share