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

15 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Enrollment Rate Among Eligible Participants
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Psychological Distress
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

7 de setembro de 2026

Conclusão Primária (Estimado)

11 de outubro de 2026

Conclusão do estudo (Estimado)

11 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

4 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2026

Primeira postagem (Real)

16 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • EMI for high ACEs

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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