An interventional study of Mindfulness Body Scan in Psychological Stress, Depression - Major Depressive Disorder and Anxiety, sponsored by Natalia Dewi Wardani, MD. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Natalia Dewi Wardani, MD · Not applicable, Interventional, and Treatment
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.
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:
Psychometric Evaluations: Assessment of psychological symptoms using validated tools, including:
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.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 70 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Natalia Dewi Wardani, MD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Mindfulness Body Scan
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.
Change in Monocyte-to-Lymphocyte Ratio (MLR)
Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 8 (post-intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 8 (post-intervention)
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 457 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 5 months is below that.
Counting every sponsor, half of 470 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Natalia Dewi Wardani, MD