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

15 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: EMI

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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Enrollment Rate Among Eligible Participants
Ramy czasowe: 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.
Through completion of recruitment, up to 3 weeks
Proportion of Eligible Participants
Ramy czasowe: 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
Intervention Engagement
Ramy czasowe: 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
Ramy czasowe: Immediately post-treatment
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.
Immediately post-treatment
Intervention acceptability
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Psychological Distress
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

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Sponsor

Peking University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

7 września 2026

Zakończenie podstawowe (Szacowany)

11 października 2026

Ukończenie studiów (Szacowany)

11 października 2026

Daty rejestracji na studia

Pierwszy przesłany

4 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 września 2026

Pierwszy wysłany (Rzeczywisty)

16 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • EMI for high ACEs

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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