Psychological DistressNCT07885579
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
A study testing EMI in people with Psychological Distress and Adverse Childhood Experience, run by Peking University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Psychological Distress, Adverse Childhood Experience
- What is being tested?
- EMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 16 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ecological Momentary Intervention to Reduce Psychological Distress in Young Adults With Multiple Adverse Childhood Experiences: A Randomized Controlled Trial
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.
- Being tested
- EMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMIBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Secondary outcomes (14)
Depressive Symptoms
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Anxiety Symptoms
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Eating Disorder Symptoms
Eating disorder symptoms will be assessed using the Chinere version of 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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Insomnia Severity
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Somatic Symptom Severity
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Suicidal Ideation
Suicidal ideation will be assessed using the first five screening items of the Beck Scale for Suicide Ideation (BSS). Each item assesses suicidal thoughts and attitudes over the preceding week, and is rated on a 3-point scale from 0 to 2. Item scores are summed to produce a total score ranging from 0 to 10, with higher scores indicating greater severity of suicidal ideation.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Self-Injurious Behavior
Self-injurious behavior will be assessed using four self-developed items. These items assess whether participants engaged in self-injury during the preceding week, the frequency of self-injurious acts, the number of days on which self-injury occurred, and the perceived likelihood of engaging in self-injury again. Higher values indicate more frequent self-injury or greater perceived likelihood of future self-injury.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Urges to Engage in Self-Injury
Urges to engage in self-injury will be assessed using the 5-item Alexian Brothers Urge to Self-Injure Scale (ABUSI). The scale assesses the frequency, intensity, duration, difficulty resisting, and overall severity of self-injury urges over the preceding week. Each item is rated on a 7-point scale from 0 to 6. Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater severity of self-injury urges.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Urgency
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Aggression
Aggression will be assessed using the 12-item Brief Aggression Questionnaire (BAQ). The scale measures four dimensions of aggression: physical aggression, verbal aggression, anger, and hostility. Each item is rated on a 7-point scale from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me). After reverse-scoring the relevant item, scores are summed to produce a total score ranging from 12 to 84, with higher scores indicating greater levels of aggression.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Functional Impairment
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Life Satisfaction
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.
Measured: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Study Retention Rate
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention and follow-up assessment.
Measured: post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
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.
Measured: post-treatment (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion16 Jan 2027 (estimated)
- Study completion16 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885579
- Sponsor's protocol ID
- RCT_EMI for high ACEs
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No