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

6. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

3000

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Fangfang Shangguan, Ph.D.
  • Telefonní číslo: ++8610-13501000369
  • E-mail: shanggff@cnu.edu.cn

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Behaviorální: 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.
Behaviorální: 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.
Žádný zásah: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Generalized Anxiety Disorder-7 Scale (GAD-7)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Positive and Negative Rumination Scale (PANRS)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing HuiLongGuan Hospital

Spolupracovníci

Tsinghua University
Capital Normal University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Xiang-Yang Zhang, Ph.D., Tsinghua University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. září 2026

Primární dokončení (Odhadovaný)

31. července 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

13. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

6. června 2026

První zveřejněno (Aktuální)

10. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CNU-202601001 (Jiný identifikátor: Capital Normal University)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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