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Study on Mental Health Promoting Effects of Natural Psychotherapy for Adolescents (NP-A-MHP)

6 czerwca 2026 zaktualizowane przez: Xiang Yang Zhang, Beijing HuiLongGuan Hospital

The Effect of Universal Intervention Based on Natural Psychotherapy: Evidence From Chinese Adolescents

This randomized controlled trial aims to evaluate the efficacy of a universal intervention based on Natural Psychotherapy in reducing anxiety and depressive symptoms among primary and middle school students. To evaluate both the clinical outcomes and the potential underlying mechanisms of change, data will be collected at four distinct time points: baseline (pre-intervention), post-intervention, 3-month follow-up, and 6-month follow-up.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Objective 1: Evaluate the Efficacy of Natural Psychotherapy on Primary Outcomes (Anxiety Symptoms and Rumination) To evaluate the short-term and sustained efficacy of the Natural Psychotherapy program in reducing anxiety symptoms and maladaptive rumination among primary and middle school students compared to standard schooling.

Objective 2: Assess the Impact on Secondary Outcomes (Psychological Well-being, Emotional Regulation, Stress, Sleep, Self-Esteem, Depression, Life Satisfaction, and Social Support) To assess the effects of the Natural Psychotherapy program on secondary psychological outcomes, including mindfulness, perceived stress, resilience, insomnia severity, self-esteem, depressive symptoms, life satisfaction, eudaimonic well-being, and perceived social support, and to examine whether improvements in these domains mediate the primary outcomes.

Objective 3: Explore the Mechanisms of Change and Predictors of Treatment Response To explore the underlying psychological mechanisms through which Natural Psychotherapy produces its therapeutic effects on primary outcomes (anxiety and rumination) and to identify baseline predictors and moderators of treatment response.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

3000

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

Kopia zapasowa kontaktu do badania

  • Nazwa: Fangfang Shangguan, Ph.D.
  • Numer telefonu: ++8610-13501000369
  • E-mail: shanggff@cnu.edu.cn

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100037
        • Capital Normal University, Beijing
        • Kontakt:

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

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • Ages: 7 to 18 years.
  • Population: School-aged children and adolescents currently enrolled and attending primary or secondary school.
  • Capacity: Ability to comprehend the study procedures and provide assent (or consent, if applicable).

Exclusion Criteria:

  • School Attendance: Children not currently attending school or on long-term academic leave.
  • General Exclusion: Any condition that, in the opinion of the investigator or school physician, would interfere with the participant's ability to attend school or comply with study procedures.

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: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Universal Intervention based on Natural Psychotherapy

Natural psychotherapy is based on "Morita therapy" and is a psychotherapy that fully reflects the characteristics of Chinese culture, taking into account the Chinese cultural background and actual clinical characteristics.

Participants will receive a 4-week Multi-model Nature-based Meditation program delivered in regular classrooms. The program consists of weekly group sessions integrating nature-guided imagery exercises with principles of Nature Psychotherapy. Intervention Diary will be collected and will receive response from trained instructors. Sessions are facilitated by trained instructors.
Behawioralne: Multi-modal Nature-based Meditation
A 4-week universal group meditation practice delivered in classrooms. The intervention aims to reduce anxiety and depressive symptoms through nature-based mindfulness exercises.
Behawioralne: Intervention diary
Participants are required to maintain a daily log of their meditation practice and life events, with a particular focus on instances of emotional fluctuation and their corresponding behavioral responses.
Brak interwencji: Standard School Education Control
Participants assigned to this arm will continue with standard school education as usual (business-as-usual) without the meditation intervention

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Generalized Anxiety Disorder-7 Scale (GAD-7)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29

A 7-item self-report scale assessing the severity of anxiety symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating more severe anxiety. Clinical cut-off scores are: 0-4 (minimal/no clinical anxiety), 5-9 (mild), 10-14 (moderate),and≥ 15 (severe). This is a widely used, valid, and reliable tool for screening and monitoring anxiety in adolescents.

Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Ruminative Responses Scale (RRS)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29

Symptom Rumination: Assesses repetitive focus on the symptoms of distress (e.g., feelings of sadness, fatigue, and loneliness).

Brooding: Assesses a moody, reflective style characterized by passive comparison of one's current situation with unachieved standards.

Reflective Pondering: Assesses purposeful and reflective examination of one's mood and its causes to gain insight.

Scoring: Each item is rated on a 4-point Likert scale from 1 (almost never) to 4 (almost always). Total scores range from 22 to 88. Higher total scores indicate a greater tendency toward rumination.

Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 15-item self-report scale measuring dispositional mindfulness.Each item is rated on a 6-point Likert scale from 1 (almost always) to 6 (almost never). Scoring is computed as the mean of all 15 items, with scores ranging from 1 to 6.Higher scores indicate greater levels of dispositional mindfulness (Brown & Ryan, 2003).Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Perceived Stress - Perceived Stress Scale (PSS-10)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 10-item self-report questionnaire measuring perceived stress over the past month.Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). Four positively worded items are reverse-scored. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Interpretive guidelines: 0-13 (low), 14-26 (moderate), 27-40 (high stress) (Cohen et al.,1983). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Resilience - Connor - Davidson Resilience Scale (CD-RISC-10)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 10-item self-report scale measuring resilience. Each item is rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all the time). Total scores range from 0 to 40, with higher scores indicating greater resilience (Campbell-Sills & Stein, 2007). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Insomnia Severity - Insomnia Severity Index (ISI)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 7-item self-report questionnaire assessing insomnia severity over the past two weeks. Each item is rated on a 5-point Likert scale from 0 (no problem) to 4 (very severe problem). Total scores range from 0 to 28,with higher scores indicating more severe insomnia. Cutoffs: 0-7 (no clinically significant insomnia), 8-14 (subthreshold), 15-21 (moderate), 22-28 (severe) (Bastien et al.,2001). Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month
Week 1, Week 5, Week 9, Week 17, Week 29
Self-Esteem -Rosenberg Self-Esteem Scale (SES)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 10-item scale measuring global self-worth and self-acceptance. Each item is rated on a 4-point Likert scale from 1 (strongly agree) to 4 (strongly disagree). Total scores range from 10 to 40, with higher scores reflecting higher self-esteem. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
The Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
The PHQ-9 is a brief and efficient self-assessment tool mainly used for screening depressive disorders (Major Depressive Disorder, MDD) and evaluating the severity of depressive symptoms. It was developed by Kurt Kroenke et al. (2001) and is one of the gold standard tools for screening depression in clinical practice and epidemiological studies. The questionnaire consists of 9 items and uses 4-point Likert scale from 0 (almost never) to 3 (almost always). The total score ranges from 0 to 27, with higher scores indicating greater depression. In this study, only the middle school groups used this questionnaire, while the primary school group did not. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Life Satisfaction
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
The research team used a self-compiled social survey questionnaire based on the actual situation of Chinese primary and secondary school students. The questionnaire consists of 6 items and uses a 5-point Likert scale (1 = very scary, 2 = very dissatisfied, 3 = about the same between satisfied and dissatisfied, 4 = very satisfied, 5 = very happy). The total score ranges from 6 to 30 points, with a higher score indicating a greater satisfaction of the individual with their current life. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Perceived Social Support - Multidimensional Scale of Perceived Social Support (MSPSS)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 12-item self-report scale assessing perceived social support from family (4 items), friends (4 items), and significant others (4 items). Each item is rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). Total scores range from 12 to 84, with higher scores indicating greater perceived social support. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Eudaimonic Well-being - Flourishing Scale (FS-8)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 8-item scale measuring psychological functioning, meaning, and social well-being. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 8 to 56,with higher scores indicating greater flourishing. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Positive and Negative Rumination Scale (PANRS)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
The aim was to separately explore the positive and negative aspects of rumination. The scale consists of 23 items and is divided into five factors: enjoying happiness, suppressing happiness, negative attribution, positive coping, and self-denial. The PANRS uses a 4-point Likert scale from 1 (almost never) to 4 (almost always). A higher score indicates a more severe tendency towards rumination. In this study, only the factors of enjoying happiness and positive coping were used. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Executive Function -Self-report Executive Function Scale
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
Assesses key aspects of executive function such as cognitive flexibility, working memory, and inhibitory control in daily functioning. In this study, only the cognitive flexibility and working memory dimensions from the scale were used. Each item is rated on a 3-point Likert scale from 1 (never) to 3 (often). After reverse scoring, total scores range from 15-45, with higher scores indicating better executive functioning. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Internet Gaming Disorder Risk - Brief Internet Gaming Disorder Scale (IGDS9-SF)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
A 9-item self-report scale screening for symptoms of problematic gaming behavior based on DSM-5 criteria. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (very often). Total scores range from 9 to 45, with higher scores indicating greater risk of internet gaming disorder. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29
Non-Suicidal Self-Injury - Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ)
Ramy czasowe: Week 1, Week 5, Week 9, Week 17, Week 29
The ANSAQ is a questionnaire assessing frequency, methods, and functions of Non-Suicidal Self-Injury (NSSI) behaviors in adolescents. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (always). This study utilized 12 items from the behavioral questionnaire. Total scores range from 0 to 48, with higher scores indicating more diverse methods or higher frequency of non-suicidal self-injury over the past year. Includes follow-up questions on context and triggers. Time points of measurements: (1) Assessment at Week 1 (Pre-intervention, Baseline); (2) Week 5( immediately Post-intervention, after the 4-week intervention period); (3) Week 9 (1-month follow-up); (4) Week 17 (3-month follow-up); (5) Week 29: 6-month follow-up.
Week 1, Week 5, Week 9, Week 17, Week 29

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing HuiLongGuan Hospital

Współpracownicy

Tsinghua University
Capital Normal University

Śledczy

  • Główny śledczy: Xiang-Yang Zhang, Ph.D., Tsinghua University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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)

15 września 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

13 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CNU-202601001 (Inny identyfikator: Capital Normal University)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared. The data are subject to confidentiality agreements due to privacy restrictions.

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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