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
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.