Psychotic DisorderFTNCT07436481
The Effectiveness of Forest Therapy on Psychotic Patients: Focusing on Changes in Inflammatory Pathways and The Psychotic Condition of Patients
A study testing Forest Therapy in people with Psychotic Disorder, run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Forest Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Consuming alcohol and immunosuppressants 1 month before sampling. Patients diagnosed with autoimmune disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Intervention (8 sessions of 8 mg) Forest therapy will be provided in the form of mindful walking, forest bathing, mindful eating, meditation, and tree hugging.
- Conditions
- Psychotic Disorder
- Being tested
- Forest Therapy
- Keywords
- forest therapy, psychotic disorder, inflammation pathway, mindfulness
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest TherapyBehavioural
Also called Shinrin-yoku
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Forest Therapy |
| Control group | No intervention | The control group will only receive standard psychotic therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP level in mg/L
hs-CRP level in miligram/Liter, interval
Measured: 8 weeks
BDNF levels in pg/ml
BDNF levels in picogram/miiliter, interval
Measured: 8 weeks
IL-6 level in pg/ml
IL-6 levels in picogram/miiliter, interval
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalia Dewi Wardani, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Indonesian Red Cross, Indonesian Red Cross
- Responsible party
- Sponsor-investigator, Natalia Dewi Wardani, MD, Universitas Diponegoro
- Investigators
- Natalia Dewi Wardani NDW Wardani, Doctoral, Principal investigator, Medical Faculty Diponegoro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436481
- Sponsor's protocol ID
- 085/EC/KEPK/FK-UNDIP/IV/2025
- Other IDs
- 48/UN7.F4/HK/IV/2025
- Acronym
- FT
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31877954
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Forest Therapy on Psychotic Patients: Focusing on Changes in Inflammatory Pathways and The Psychotic Condition of Patients
- ClinicalTrials.gov ID
- NCT07436481
- Acronym / sponsor ID
- FT / 085/EC/KEPK/FK-UNDIP/IV/2025
- Conditions
- Psychotic Disorder
- Keywords
- forest therapy, psychotic disorder, inflammation pathway, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Natalia Dewi Wardani, MDUniversity, hospital or other
- Collaborators
- The Indonesian Red Cross, Indonesian Red Cross
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intervention (8 sessions of 8 mg) Forest therapy will be provided in the form of mindful walking, forest bathing, mindful eating, meditation, and tree hugging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Forest therapy group intervention | Experimental | Behavioral: Forest TherapyThe 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. |
| Control group | No intervention | –The control group will only receive standard psychotic therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Consuming alcohol and immunosuppressants 1 month before sampling. Patients diagnosed with autoimmune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forest TherapyAlso: Shinrin-yokuThe 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. | Behavioural | Forest therapy group intervention |
Primary outcome
CRP level in mg/L
Time frame: 8 weeks
hs-CRP level in miligram/Liter, interval
BDNF levels in pg/ml
Time frame: 8 weeks
BDNF levels in picogram/miiliter, interval
IL-6 level in pg/ml
Time frame: 8 weeks
IL-6 levels in picogram/miiliter, interval
Psychotic Condition with Positive and Negative Syndrome Scale (PANSS)
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 31877954Bielinis 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Dewi Wardani NDW Wardani, Doctoral principal investigator
Medical Faculty Diponegoro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest Therapy in people with Psychotic Disorder, run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP level in mg/L (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07436481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.