The Dynamic Mechanism of Mindfulness Intervention for Emotional Distress (MIED) Based on Ecological Moment Measurement
2 de setembro de 2026 atualizado por: Xinghua Liu, Peking University
The goal of this clinical trial is to examine how a mindfulness-based intervention (MIED) affects the moment-to-moment, lagged relationships between mechanism variables at the levels of feelings, thoughts, and behaviors and outcomes (anxiety and depression) in individuals experiencing anxiety and depressive distress, using high-frequency ecological momentary assessment. The main questions it aims to answer are:
At the within-person level, do these mechanism variables significantly predict next-moment anxiety and depressive symptoms at the within-day micro-scale?
How does the temporal dynamic between mechanism and outcomes over the course of MIED?
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
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
- Nome: MO CHEN
- Número de telefone: 86 +18950308693
- E-mail: amor_chen@foxmail.com
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
Sim
Descrição
Inclusion Criteria:
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
Exclusion Criteria:
- Subjects who could not access the Internet.
- Subjects with insufficient Chinese ability.
- Subjects who have participated in mindfulness-based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week.
- Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder.
- Subjects at risk of suicide.
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 |
|---|---|
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Experimental: MIED Self-help Intervention Group
Participants receive a 49-day self-help intervention delivered via a Mini Program.
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A 49-day digital self-help program delivered via a WeChat Mini Program (or mobile app).
Each day, participants receive a new set of materials: (a) a guided mindfulness meditation audio (10-30 minutes), (b) psychoeducational content in text or audio format covering mindfulness principles, emotion, and emotional distress, and (c) daily assignments (such as informal mindfulness practices, emotion journaling, and graded challenging tasks).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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changes of depression
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of anxiety
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of mindfulness
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day.
Each item is rated on a scale ranging from 1 (rarely) to 10 (often).
scores range from 4 to 40, with higher scores indicating higher levels of mindful responding
|
At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of distress tolerance
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
3 items were chosen to form the Daily Distress Tolerance Scale (DDTS).
The DDTS consists of four items.
Each item is rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree).
Scores range from 3 to 15, with higher scores indicating greater distress tolerance.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of engaging in life
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
4 items were chosen from Enaging in Life Scale which assesses the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life (Chen et al.,2026).
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of physical distress intolerance
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Momentary bodily discomfort tolerance will be assessed using a single self-developed item: "Right now, I am able to allow unpleasant bodily sensations to be present without trying to get rid of them immediately."
Participants will respond on a 7-point scale ranging from 0 ("not at all able") to 6 ("completely able").
Higher scores indicate greater momentary ability to tolerate and allow unpleasant bodily sensations without immediately attempting to avoid or eliminate them.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of experiential avoidance
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Based on a preliminary study, the items with the high factor loading （at least higher than 0.6） from each subscale of the Brief Experiential Avoidance Questionnaire ( Gámez et al, 2013) were chosen to form the Daily Experiential Avoidance Scale (DEAS).
The DEAS consists of four items.
Each item is rated on a scale ranging from 1 (strongly agree) to 6 (strongly disagree).
Scores range from 5 to 30, with higher scores indicating less experiential avoidance.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of rumination
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
State rumination will be assessed using a single-item visual analogue scale adapted from prior research.
Participants will rate the extent to which they are currently caught up in their emotions and problems and find it difficult to step back from them ("Right now, I am caught up in my emotions and problems and find it difficult to distance myself from them") on a slider ranging from 0 ("not at all") to 100 ("extremely").
Higher scores indicate greater momentary rumination.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of negative emotion
Prazo: At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Negative affect will be assessed using four items adapted from the Positive and Negative Affect Schedule (PANAS).
Participants will rate the intensity of their current feelings of anxiety, sadness, irritability, and tension ("Right now, I feel anxious/sad/irritable/tense") using a visual analogue slider ranging from 0 ("not at all") to 100 ("extremely").
Higher scores indicate greater momentary negative affect.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
5 de setembro de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
22 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
27 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E20260827
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
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