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

NCT07885579 | Not Yet Recruiting

• 1 other identifier: RCT_EMI for high ACEs
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of an ecological momentary intervention (EMI) in reducing psychological distress among young adults with multiple adverse childhood experiences (ACEs). The intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. Approximately 100 young adults aged 18-29 years who have experienced at least two types of ACEs and report elevated psychological distress will be recruited. Participants will be randomly assigned in a 1:1 ratio to either the EMI intervention group or the waitlist control group. Those assigned to the intervention group will receive a 2-week smartphone-based EMI delivered in their daily lives. Intervention effectiveness will be evaluated by comparing changes in psychological distress and related psychological outcomes between the two groups.

Conditions

Psychological Distress; Adverse Childhood Experience

Outcome Measures

Primary Outcomes (4)

• Psychological Distress

  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, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Catastrophizing

  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, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Self-Esteem

  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, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Emotional clarity

  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, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

Secondary Outcomes (14)

• Depressive Symptoms

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Anxiety Symptoms

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Eating Disorder Symptoms

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Insomnia Severity

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Somatic Symptom Severity

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

Other Outcomes (8)

• Alcohol Use

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Externalizing Behaviors

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

• Psychotic-Like Experiences

  baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

Study Arms (2)

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

Waitlist control group

NO INTERVENTION

Participants assigned to the waitlist control group will not receive the ecological momentary intervention (EMI) during the intervention and follow-up periods. They will complete the same outcome assessments as participants in the EMI intervention group. In addition, participants will undergo brief weekly assessments to identify any significant deterioration in mental health and assess suicide risk. After completing the final follow-up assessment, participants in the waitlist control group will be offered access to the same 2-week smartphone-based EMI program.

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 19, 2026
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): January 16, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share