Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

The Dynamic Mechanism of Mindfulness Intervention for Emotional Distress (MIED) Based on Ecological Moment Measurement

2 września 2026 zaktualizowane przez: 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?

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

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

Tak

Opis

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.

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: MIED Self-help Intervention Group
Participants receive a 49-day self-help intervention delivered via a Mini Program.
Behawioralne: Mindfulness Intervention for emotional distress(MIED）
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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
changes of depression
Ramy czasowe: 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 Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
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
changes of anxiety
Ramy czasowe: 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.
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
changes of mindfulness
Ramy czasowe: 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
changes of distress tolerance
Ramy czasowe: 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.
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
changes of engaging in life
Ramy czasowe: 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).
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
changes of physical distress intolerance
Ramy czasowe: 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
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.
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
changes of experiential avoidance
Ramy czasowe: 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
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.
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
changes of rumination
Ramy czasowe: 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.
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
changes of negative emotion
Ramy czasowe: 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
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.
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

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)

5 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

22 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

27 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 września 2026

Pierwszy wysłany (Rzeczywisty)

9 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • E20260827

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 .

Subskrybuj