EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
15. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Yinyin Zang
- Telefonní číslo: 010-62756953
- E-mail: Yinyin.Zang@pku.edu.cn
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Enrollment Rate Among Eligible Participants
Časové okno: 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.
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Through completion of recruitment, up to 3 weeks
|
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Proportion of Eligible Participants
Časové okno: 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
|
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Intervention Engagement
Časové okno: 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
Časové okno: Immediately post-treatment
|
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.
|
Immediately post-treatment
|
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Intervention acceptability
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Psychological Distress
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
7. září 2026
Primární dokončení (Odhadovaný)
11. října 2026
Dokončení studie (Odhadovaný)
11. října 2026
Termíny zápisu do studia
První předloženo
4. září 2026
První předloženo, které splnilo kritéria kontroly kvality
15. září 2026
První zveřejněno (Aktuální)
16. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- EMI for high ACEs
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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