NCT07436481

Brief Summary

General Formulation Are there any changes in the inflammatory pathway and psychotic conditions in patients given Forest Therapy compared to conventional psychotic disorder therapy? Specific Are there any differences in the levels of inflammatory factors such as CRP, IL-6, and BDNF in patients given Forest Therapy compared to conventional psychotic disorder therapy? Are there differences in the psychotic conditions of patients, as assessed by PANSS, MADRSS, DASS-21, YMRS, Zung Anxiety Self Questionnaire, PSQI, and WHO-QL BREF, in patients receiving Forest Therapy compared to conventional psychotic disorder therapy? 1.3 Research Objectives 1.3.1 General Objective To determine the changes that occur in the inflammatory pathway and psychotic condition in patients receiving Forest Therapy compared to conventional psychotic disorder therapy. 1.3.2 Specific Objective To determine changes in the inflammatory pathway, particularly CRP, IL-6, and BDNF, in patients receiving Forest Therapy compared to conventional psychotic disorder therapy. To determine changes in psychotic conditions using the PANSS, BDI, MADRS, DASS-21, YMRS, Zung Anxiety Self Questionnaire, PSQI, and WHO-QL-BREF questionnaires in patients receiving Forest Therapy compared to conventional psychotic disorder therapy. To investigate the relationship between changes in inflammatory pathways and changes in psychotic conditions in patients receiving Forest Therapy compared to conventional psychotic disorder therapy. The research group will be divided into two groups using randomisation. The treatment group will receive forest therapy in the Mangkang forest from June to September 2025, with one session every two weeks for a total of eight sessions, while the control group will receive treatment for psychotic disorders as usual. Both groups will undergo psychometric testing, which includes assessment of psychotic symptoms, mood, insomnia, anxiety, stress levels, and quality of life. Blood samples will also be collected for complete blood count and inflammatory factor testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 21, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

forest therapypsychotic disorderinflammation pathwaymindfulness

Outcome Measures

Primary Outcomes (4)

  • CRP level in mg/L

    hs-CRP level in miligram/Liter, interval

    8 weeks

  • BDNF levels in pg/ml

    BDNF levels in picogram/miiliter, interval

    8 weeks

  • IL-6 level in pg/ml

    IL-6 levels in picogram/miiliter, interval

    8 weeks

  • Psychotic Condition with Positive and Negative Syndrome Scale (PANSS)

    Psychotic Condition with Positive and Negative Syndrome Scale (PANSS) score, total score ranges from 30 to 210, with higher scores indicating greater symptom severity in schizophrenia patients.

    8 weeks

Study Arms (2)

Forest therapy group intervention

EXPERIMENTAL

The intervention group will receive standard psychotic therapy and participate in forest therapy activities consisting of mindful forest walking, sun bathing, forest hugging and meditation. These activities will be carried out over 8 sessions, with each session taking place once a week. This group will be randomly divided into 4 small groups, each consisting of 10 participants. Each small group will be led by a trained therapist. These activities will last for 2 hours per session.

Behavioral: Forest Therapy

Control group

NO INTERVENTION

The control group will only receive standard psychotic therapy.

Interventions

Forest TherapyBEHAVIORAL

The intervention group will receive standard psychotic therapy and participate in forest therapy activities consisting of mindful forest walking, sun bathing, forest hugging and meditation. These activities will be carried out over 8 sessions, with each session taking place once a week. The control group will be randomly divided into 4 small groups, each consisting of 10 participants. Each small group will be led by a trained therapist. These activities will last for 2 hours per session.

Also known as: Shinrin-yoku
Forest therapy group intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60 years old
  • Diagnosed with psychosis based on medical records at Dr. Kariadi General Hospital, Diponegoro National Hospital, Elisabeth Hospital Semarang and Banyumanik I Hospital Semarang
  • Minimum education level of junior high school (SMP)
  • Willing to participate in research

You may not qualify if:

  • Consuming alcohol and immunosuppressants 1 month before sampling. Patients diagnosed with autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kendal Forest- PMI Semarang

Semarang, Central Java, 50131, Indonesia

Location

Related Publications (1)

  • Bielinis E, Jaroszewska A, Lukowski A, Takayama N. The Effects of a Forest Therapy Programme on Mental Hospital Patients with Affective and Psychotic Disorders. Int J Environ Res Public Health. 2019 Dec 23;17(1):118. doi: 10.3390/ijerph17010118.

    PMID: 31877954BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Natalia Dewi Wardani NDW Wardani, Doctoral

    Medical Faculty Diponegoro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each patient was assigned an identification number, and the researcher who drew blood did not know whether the patient was in the treatment group or the control group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The treatment group will receive forest therapy in the Mangkang forest from June to September 2025, with a frequency of once every two weeks for 8 sessions, while the control group will undergo psychotic disorder therapy as usual. Both groups will undergo psychometric testing, including assessment of psychotic symptoms, mood, insomnia, anxiety, stress levels, and quality of life. Blood samples will also be collected for complete blood count and inflammatory factor testing.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Psychiatry Residency Program Medical Faculty Diponegoro University, Principal Investigator

Study Record Dates

First Submitted

February 21, 2026

First Posted

February 27, 2026

Study Start

June 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The data are not publicly available due to privacy or ethical restrictions. The dataset involves sensitive information about mental health, and sharing it publicly would compromise participant confidentiality as per the ethical approval obtained.

Available IPD Datasets

Informed Consent Form (pdf file)Access

Locations