- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436481
The Effectiveness of Forest Therapy on Psychotic Patients: Focusing on Changes in Inflammatory Pathways and The Psychotic Condition of Patients (FT)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central Java
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Semarang, Central Java, Indonesia, 50131
- Kendal Forest- PMI Semarang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Consuming alcohol and immunosuppressants 1 month before sampling. Patients diagnosed with autoimmune disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Forest therapy group intervention
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.
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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.
Other Names:
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No Intervention: Control group
The control group will only receive standard psychotic therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CRP level in mg/L
Time Frame: 8 weeks
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hs-CRP level in miligram/Liter, interval
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8 weeks
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BDNF levels in pg/ml
Time Frame: 8 weeks
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BDNF levels in picogram/miiliter, interval
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8 weeks
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IL-6 level in pg/ml
Time Frame: 8 weeks
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IL-6 levels in picogram/miiliter, interval
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8 weeks
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Psychotic Condition with Positive and Negative Syndrome Scale (PANSS)
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Natalia Dewi Wardani NDW Wardani, Doctoral, Medical Faculty Diponegoro University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 085/EC/KEPK/FK-UNDIP/IV/2025
- 48/UN7.F4/HK/IV/2025 (Other Grant/Funding Number: HIBAH FK UNDIP 2025)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Informed Consent Form
Information identifier: pdf fileInformation comments: klik the link to get informed consent file in English
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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