Psychological StressNCT07796919
The Effect of Mindfulness in Inflammation Markers (MLR, NLR, PLR), Stress, Anxiety, and Depression Rate Among Survivors of Tidal Flooding in Sayung Demak
A study testing Mindfulness Body Scan in people with Psychological Stress and Depression - Major Depressive Disorder, run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
Trial summary
Tidal flood disasters in coastal areas cause chronic psychological stress due to economic, social, and residential disruption. Psychological stress is closely linked to systemic inflammatory responses-marked by elevated Monocyte-to-Lymphocyte Ratio (MLR), Neutrophil-to-Lymphocyte Ratio (NLR), and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety
- What is being tested?
- Mindfulness Body Scan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 60 years.
- Survivors of tidal flooding (bencana rob) residing in the Sayung coastal area for at least 6 months.
- Minimum educational attainment of Primary School (Sekolah Dasar / SD).
- Literate in Indonesian (able to read and write).
- Willing to participate in and complete the 8-day mindfulness intervention program.
- Physically independent and capable of completing self-administered questionnaires.
Who cannot join
- Active psychotic disorders or severe mental illness.
- Cognitive impairment that limits ability to complete assessments.
- History of diagnosed autoimmune disorders, active allergies, or chronic inflammatory diseases.
- Presence of acute infectious disease symptoms within the past 1 month.
- Currently undergoing formal psychotherapy or other structured psychological interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Tidal flood disasters in coastal areas cause chronic psychological stress due to economic, social, and residential disruption. Psychological stress is closely linked to systemic inflammatory responses-marked by elevated Monocyte-to-Lymphocyte Ratio (MLR), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR)-which are associated with depression and anxiety symptoms. Mindfulness interventions, particularly body scan techniques, have been shown to reduce psychological distress and modulate immune responses, but empirical evidence on coastal flood survivors in Indonesia remains limited.
This study aims to evaluate the effectiveness of a community-based mindfulness body scan intervention on inflammatory biomarkers (MLR, NLR, PLR) and psychological parameters (stress, depression, anxiety, trauma, sleep quality, and resilience) among tidal flood survivors in Sayung, Demak. Participants will undergo baseline blood work and psychometric assessments, receive an 8-day mindfulness body scan intervention, and complete post-intervention evaluations.
Read the detailed description
Background:
Coastal communities in Sayung District, Demak Regency, face recurrent tidal flooding (rob) that causes continuous environmental and economic pressure. From a psychoneuroimmunological perspective, chronic psychosocial stress triggers systemic low-grade inflammation. Biomarkers such as MLR, NLR, and PLR serve as accessible systemic inflammatory indices that correlate with mood disorders and stress severity. Mindfulness body scan training aims to improve interoceptive awareness, emotional regulation, and parasympathetic activity, thereby reducing stress reactivity and systemic inflammation.
Study Design and Objectives:
This is an interventional pre-post experimental study conducted at the Sayung 1 Public Health Center (Puskesmas Sayung 1), Demak. The study evaluates changes in systemic inflammatory markers and psychological parameters pre- and post-intervention.
Intervention:
Participants will participate in a structured mindfulness body scan program over an 8-day period. The body scan protocol guides participants to direct attention sequentially to various body regions without judgment to enhance somatic awareness and stress mitigation.
Assessments:
- Laboratory Testing: Complete blood counts to determine monocyte, neutrophil, platelet, and lymphocyte ratios (MLR, NLR, PLR) pre- and post-intervention.
- Psychometric Evaluations: Assessment of psychological symptoms using validated tools, including:
- Beck Depression Inventory (BDI) \& Patient Health Questionnaire-9 (PHQ-9)
- Depression, Anxiety, and Stress Scale-21 (DASS-21)
- Impact of Event Scale - Revised (IES-R) \& PTSD Checklist-5 (PCL-5)
- Pittsburgh Sleep Quality Index (PSQI)
- Connor-Davidson Resilience Scale (CD-RISC)
- Spiritual Wellbeing Scale (SWBS)
- Fatigue Assessment Scale (FAS)
- WHO Quality of Life (WHOQOL)
- Perceived Social Performance (PSP)
Data Analysis:
Pre- and post-intervention data will be analyzed using paired statistical tests and multivariate regression to determine changes in inflammatory markers and psychological scores, as well as the correlation between systemic inflammation changes and psychological recovery.
- Conditions
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety, Post-traumatic Stress Symptoms, Inflammation, Survivor
- Being tested
- Mindfulness Body Scan
- Keywords
- Mindfulness, MLR, NLR, PLR, Stress, Anxiety, Depression, Flood
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Inflammation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Body ScanBehavioural
A structured 8-day behavioral intervention consisting of guided mindfulness body scan practices. Participants are instructed to direct non-judgmental attention sequentially across different regions of the body to enhance somatic awareness, promote relaxation, and reduce psychological stress reactivity.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Body Scan Group | Experimental | Participants in this single arm receive an 8-day community-based mindfulness body scan training designed to evaluate its effects on systemic inflammatory markers (MLR, NLR, PLR) and psychological parameters. Receives: Behavioral: Mindfulness Body Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monocyte-to-Lymphocyte Ratio (MLR)
Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.
Measured: Baseline and Day 8 (post-intervention)
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Changes in NLR derived from routine complete blood count to evaluate systemic inflammation
Measured: Baseline and Day 8 (post-intervention)
Change in Platelet-to-Lymphocyte Ratio (PLR)
Changes in PLR derived from routine complete blood count to evaluate systemic inflammation.
Measured: Baseline and Day 8 (post-intervention)
Change in DASS-21 Score
Evaluation of changes in psychological distress using the Depression, Anxiety, and Stress Scale-21 (DASS-21). Total score ranges from 0 to 63, where higher scores indicate higher levels of psychological distress.
Measured: Baseline and Day 8 (post-intervention)
Change in Beck Depression Inventory (BDI) Score
Evaluation of changes in depressive symptoms using the BDI questionnaire. Total score ranges from 0 to 63, where higher scores indicate more severe depression.
Measured: Baseline and Day 8 (post-intervention)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Evaluation of depression severity using the PHQ-9 scale. Total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms.
Measured: Baseline and Day 8 (post-intervention)
Secondary outcomes (4)
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Evaluation of sleep quality using the PSQI questionnaire. Total score ranges from 0 to 21, where higher scores indicate poorer sleep quality.
Measured: Baseline and Day 8 (post-intervention)
Change in Connor-Davidson Resilience Scale (CD-RISC) Score
Evaluation of psychological resilience levels using the CD-RISC questionnaire. Total score ranges from 0 to 100, where higher scores indicate greater resilience.
Measured: Baseline and Day 8 (post-intervention)
Change in Impact of Event Scale-Revised (IES-R) Score
Evaluation of post-traumatic stress distress related to the tidal flood disaster using the IES-R. Total score ranges from 0 to 88, where higher scores indicate greater post-traumatic distress.
Measured: Baseline and Day 8 (post-intervention)
Change in WHOQOL-BREF Score
Evaluation of quality of life across physical, psychological, social, and environmental domains using the WHOQOL-BREF scale. Domain scores are transformed to a scale of 0 to 100, where higher scores indicate higher quality of life.
Measured: Baseline and Day 8 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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 Psychological StressStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalia Dewi Wardani, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natalia Dewi Wardani, MD, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796919
- Sponsor's protocol ID
- FK-UNDIP-MIND-02
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 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
Kabat-Zinn J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York: Dell Publishing; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness in Inflammation Markers (MLR, NLR, PLR), Stress, Anxiety, and Depression Rate Among Survivors of Tidal Flooding in Sayung Demak
- ClinicalTrials.gov ID
- NCT07796919
- Acronym / sponsor ID
- FK-UNDIP-MIND-02
- Conditions
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety, Post-traumatic Stress Symptoms, Inflammation, Survivor
- Keywords
- Mindfulness, MLR, NLR, PLR, Stress, Anxiety, Depression, Flood
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Natalia Dewi Wardani, MDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Sep 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.
Tidal flood disasters in coastal areas cause chronic psychological stress due to economic, social, and residential disruption. Psychological stress is closely linked to systemic inflammatory responses-marked by elevated Monocyte-to-Lymphocyte Ratio (MLR), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR)-which are associated with depression and anxiety symptoms. Mindfulness interventions, particularly body scan techniques, have been shown to reduce psychological distress and modulate immune responses, but empirical evidence on coastal flood survivors in Indonesia remains limited.
This study aims to evaluate the effectiveness of a community-based mindfulness body scan intervention on inflammatory biomarkers (MLR, NLR, PLR) and psychological parameters (stress, depression, anxiety, trauma, sleep quality, and resilience) among tidal flood survivors in Sayung, Demak. Participants will undergo baseline blood work and psychometric assessments, receive an 8-day mindfulness body scan intervention, and complete post-intervention evaluations.
Detailed description
Background:
Coastal communities in Sayung District, Demak Regency, face recurrent tidal flooding (rob) that causes continuous environmental and economic pressure. From a psychoneuroimmunological perspective, chronic psychosocial stress triggers systemic low-grade inflammation. Biomarkers such as MLR, NLR, and PLR serve as accessible systemic inflammatory indices that correlate with mood disorders and stress severity. Mindfulness body scan training aims to improve interoceptive awareness, emotional regulation, and parasympathetic activity, thereby reducing stress reactivity and systemic inflammation.
Study Design and Objectives:
This is an interventional pre-post experimental study conducted at the Sayung 1 Public Health Center (Puskesmas Sayung 1), Demak. The study evaluates changes in systemic inflammatory markers and psychological parameters pre- and post-intervention.
Intervention:
Participants will participate in a structured mindfulness body scan program over an 8-day period. The body scan protocol guides participants to direct attention sequentially to various body regions without judgment to enhance somatic awareness and stress mitigation.
Assessments:
- Laboratory Testing: Complete blood counts to determine monocyte, neutrophil, platelet, and lymphocyte ratios (MLR, NLR, PLR) pre- and post-intervention.
- Psychometric Evaluations: Assessment of psychological symptoms using validated tools, including:
- Beck Depression Inventory (BDI) \& Patient Health Questionnaire-9 (PHQ-9)
- Depression, Anxiety, and Stress Scale-21 (DASS-21)
- Impact of Event Scale - Revised (IES-R) \& PTSD Checklist-5 (PCL-5)
- Pittsburgh Sleep Quality Index (PSQI)
- Connor-Davidson Resilience Scale (CD-RISC)
- Spiritual Wellbeing Scale (SWBS)
- Fatigue Assessment Scale (FAS)
- WHO Quality of Life (WHOQOL)
- Perceived Social Performance (PSP)
Data Analysis:
Pre- and post-intervention data will be analyzed using paired statistical tests and multivariate regression to determine changes in inflammatory markers and psychological scores, as well as the correlation between systemic inflammation changes and psychological recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Body Scan Group | Experimental | Behavioral: Mindfulness Body ScanParticipants in this single arm receive an 8-day community-based mindfulness body scan training designed to evaluate its effects on systemic inflammatory markers (MLR, NLR, PLR) and psychological parameters. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 60 years.
- Survivors of tidal flooding (bencana rob) residing in the Sayung coastal area for at least 6 months.
- Minimum educational attainment of Primary School (Sekolah Dasar / SD).
- Literate in Indonesian (able to read and write).
- Willing to participate in and complete the 8-day mindfulness intervention program.
Key exclusion criteria (5 listed)
- Active psychotic disorders or severe mental illness.
- Cognitive impairment that limits ability to complete assessments.
- History of diagnosed autoimmune disorders, active allergies, or chronic inflammatory diseases.
- Presence of acute infectious disease symptoms within the past 1 month.
- Currently undergoing formal psychotherapy or other structured psychological interventions.
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 |
|---|---|---|
| Mindfulness Body ScanA structured 8-day behavioral intervention consisting of guided mindfulness body scan practices. Participants are instructed to direct non-judgmental attention sequentially across different regions of the body to enhance somatic awareness, promote relaxation, and reduce psychological stress reactivity. | Behavioural | Mindfulness Body Scan Group |
Primary outcome
Change in Monocyte-to-Lymphocyte Ratio (MLR)
Time frame: Baseline and Day 8 (post-intervention)
Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Baseline and Day 8 (post-intervention)
Changes in NLR derived from routine complete blood count to evaluate systemic inflammation
Change in Platelet-to-Lymphocyte Ratio (PLR)
Time frame: Baseline and Day 8 (post-intervention)
Changes in PLR derived from routine complete blood count to evaluate systemic inflammation.
Change in DASS-21 Score
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of changes in psychological distress using the Depression, Anxiety, and Stress Scale-21 (DASS-21). Total score ranges from 0 to 63, where higher scores indicate higher levels of psychological distress.
Change in Beck Depression Inventory (BDI) Score
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of changes in depressive symptoms using the BDI questionnaire. Total score ranges from 0 to 63, where higher scores indicate more severe depression.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of depression severity using the PHQ-9 scale. Total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms.
4 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and Day 8 (post-intervention)
Change in Connor-Davidson Resilience Scale (CD-RISC) Score
Time frame: Baseline and Day 8 (post-intervention)
Change in Impact of Event Scale-Revised (IES-R) Score
Time frame: Baseline and Day 8 (post-intervention)
Change in WHOQOL-BREF Score
Time frame: Baseline and Day 8 (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- BackgroundKabat-Zinn J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York: Dell Publishing; 2013.
- ethics committee RSUP dr.Kariadi websiteLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Body Scan in people with Psychological Stress and Depression - Major Depressive 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Dewi Wardani Dr. dr. Sp.KJ(K) (+6281325683134, anatdew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monocyte-to-Lymphocyte Ratio (MLR) (time frame: Baseline and Day 8 (post-intervention)). The study lists 6 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 NCT07796919, 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 1 Sep 2026.