Study on Mental Health Promoting Effects of Natural Psychotherapy for Adolescents

NCT07639476 | Not Yet Recruiting DMC

• 1 other identifier: CNU-202601001
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders; Mental Health; Depressive Disorder

Keywords

Mindfulness; Depression; Emotional Regulation; Cognitive Flexibility; Primary School Students; Middle School Students; Feasibility; Natural Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Disorder-7 Scale (GAD-7)

  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)

  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

Secondary Outcomes (9)

• Mindfulness - Mindful Attention Awareness Scale (MAAS)

  Week 1, Week 5, Week 9, Week 17, Week 29

• Perceived Stress - Perceived Stress Scale (PSS-10)

  Week 1, Week 5, Week 9, Week 17, Week 29

• Resilience - Connor - Davidson Resilience Scale (CD-RISC-10)

  Week 1, Week 5, Week 9, Week 17, Week 29

• Insomnia Severity - Insomnia Severity Index (ISI)

  Week 1, Week 5, Week 9, Week 17, Week 29

• Self-Esteem -Rosenberg Self-Esteem Scale (SES)

  Week 1, Week 5, Week 9, Week 17, Week 29

Other Outcomes (4)

• Positive and Negative Rumination Scale (PANRS)

  Week 1, Week 5, Week 9, Week 17, Week 29

• Executive Function -Self-report Executive Function Scale

  Week 1, Week 5, Week 9, Week 17, Week 29

• Internet Gaming Disorder Risk - Brief Internet Gaming Disorder Scale (IGDS9-SF)

  Week 1, Week 5, Week 9, Week 17, Week 29

Study Arms (2)

Universal Intervention based on Natural Psychotherapy

ACTIVE COMPARATOR

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.

Behavioral: Multi-modal Nature-based Meditation; Behavioral: Intervention diary

Standard School Education Control

NO INTERVENTION

Participants assigned to this arm will continue with standard school education as usual (business-as-usual) without the meditation intervention

Interventions

Intervention diary BEHAVIORAL

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.

Universal Intervention based on Natural Psychotherapy

Multi-modal Nature-based Meditation BEHAVIORAL

A 4-week universal group meditation practice delivered in classrooms. The intervention aims to reduce anxiety and depressive symptoms through nature-based mindfulness exercises.

Universal Intervention based on Natural Psychotherapy

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• School Attendance: Children not currently attending school or on long-term academic leave.

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead
• Capital Normal University: collaborator
• Tsinghua University: collaborator

Study Sites (1)

Capital Normal University, Beijing

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (3)

• Koivisto, M. , & Grassini, S. . (2022). Mental imagery of nature induces positive psychological effects. Current Psychology, 1-16.

  BACKGROUND

• Chen YQ, Li XR, Zhang L, Zhu WB, Wu YQ, Guan XN, Xiu MH, Zhang XY. Therapeutic Response Is Associated With Antipsychotic-Induced Weight Gain in Drug-Naive First-Episode Patients With Schizophrenia: An 8-Week Prospective Study. J Clin Psychiatry. 2021 May 11;82(3):20m13469. doi: 10.4088/JCP.20m13469.

  PMID: 34004092 BACKGROUND

• Wang DM, Chen DC, Xiu MH, Wang L, Kosten TR, Zhang XY. A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naive first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphisms. Neuropsychopharmacology. 2024 Apr;49(5):893-902. doi: 10.1038/s41386-023-01760-8. Epub 2023 Oct 30.

  PMID: 37903861 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Psychological Well-Being; Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms; Self-Control; Social Behavior

Study Officials

• Xiang-Yang Zhang, Ph.D.

  Tsinghua University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang-Yang Zhang, Ph.D.

CONTACT

+86-10-62710644; zhangxy99@mail.tsinghua.edu.cn

Fangfang Shangguan, Ph.D.

CONTACT

++8610-13501000369; shanggff@cnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either the intervention group (receiving universal intervention program) or the control group (receiving business-as-usual education).

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)