EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
15 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yinyin Zang
- Número de teléfono: 010-62756953
- Correo electrónico: Yinyin.Zang@pku.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Enrollment Rate Among Eligible Participants
Periodo de tiempo: 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
Periodo de tiempo: Through completion of recruitment, up to 3 weeks
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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.
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Through completion of recruitment, up to 3 weeks
|
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Intervention Engagement
Periodo de tiempo: Throughout the 2-week intervention
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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.
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Throughout the 2-week intervention
|
|
Study Retention Rate
Periodo de tiempo: Immediately post-treatment
|
Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment.
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Immediately post-treatment
|
|
Intervention acceptability
Periodo de tiempo: 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.
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Immediately post-treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Psychological Distress
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
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Self-Esteem
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Emotional clarity
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Depressive Symptoms
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Anxiety Symptoms
Periodo de tiempo: Baseline and immediately post-treatment
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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.
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Baseline and immediately post-treatment
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Eating Disorder Symptoms
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Insomnia Severity
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Somatic Symptom Severity
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
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Suicidal Ideation
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
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Self-Harm Severity
Periodo de tiempo: Baseline and immediately post-treatment
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Self-harm will be assessed using a study-developed self-report questionnaire assessing the severity of self-harm behaviors.
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Baseline and immediately post-treatment
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Urgency
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
|
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Functional Impairment
Periodo de tiempo: Baseline and immediately post-treatment
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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.
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Baseline and immediately post-treatment
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Life Satisfaction
Periodo de tiempo: Baseline and immediately post-treatment
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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.
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Baseline and immediately post-treatment
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Self-Compassion
Periodo de tiempo: 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.
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Baseline and immediately post-treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
7 de septiembre de 2026
Finalización primaria (Estimado)
11 de octubre de 2026
Finalización del estudio (Estimado)
11 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Publicado por primera vez (Actual)
16 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- EMI for high ACEs
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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