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

6. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Fangfang Shangguan, Ph.D.
  • Telefonnummer: ++8610-13501000369
  • E-mail: shanggff@cnu.edu.cn

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: Standard School Education Control
Participants assigned to this arm will continue with standard school education as usual (business-as-usual) without the meditation intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Generalized Anxiety Disorder-7 Scale (GAD-7)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive and Negative Rumination Scale (PANRS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing HuiLongGuan Hospital

Samarbejdspartnere

Tsinghua University
Capital Normal University

Efterforskere

  • Ledende efterforsker: Xiang-Yang Zhang, Ph.D., Tsinghua University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

6. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CNU-202601001 (Anden identifikator: Capital Normal University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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