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NCT Number: NCT07823114

EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: 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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Enrollment Rate Among Eligible Participants

    Time frame: 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.

  2. Proportion of Eligible Participants

    Time frame: 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.

  3. Intervention Engagement

    Time frame: 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.

  4. Study Retention Rate

    Time frame: Immediately post-treatment

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

  5. Intervention acceptability

    Time frame: 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.

Secondary outcomes

  1. Psychological Distress

    Time frame: 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.

  2. Catastrophizing

    Time frame: 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.

  3. Self-Esteem

    Time frame: 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.

  4. Emotional clarity

    Time frame: 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.

  5. Depressive Symptoms

    Time frame: 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.

  6. Anxiety Symptoms

    Time frame: 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.

  7. Eating Disorder Symptoms

    Time frame: 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.

  8. Insomnia Severity

    Time frame: 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.

  9. Somatic Symptom Severity

    Time frame: 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.

  10. Suicidal Ideation

    Time frame: 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.

  11. Self-Harm Severity

    Time frame: Baseline and immediately post-treatment

    Self-harm will be assessed using a study-developed self-report questionnaire assessing the severity of self-harm behaviors.

  12. Urgency

    Time frame: 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.

  13. Functional Impairment

    Time frame: 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.

  14. Life Satisfaction

    Time frame: 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.

  15. Self-Compassion

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yinyin Zang

CONTACT

[email protected]

010-62756953

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Ecological Momentary Intervention for Reducing Psychological Distress in Young Adults With Multiple Adverse Childhood Experiences: A Feasibility Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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