An interventional study of Mindfulness Body Scan Training 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. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Natalia Dewi Wardani, MD · Not applicable, Interventional, and Treatment
Recurrent tidal flooding (rob) in the coastal areas of Sayung District, Demak Regency, poses a continuous environmental threat that inflicts housing damage, economic instability, and prolonged socioeconomic uncertainty on local residents. These chronic stressors frequently trigger significant psychological distress, including elevated levels of stress, anxiety, and depression, while simultaneously activating systemic inflammatory pathways and dysregulating the hypothalamic-pituitary-adrenal (HPA) axis.
Mindfulness body scan is a structured, non-pharmacological mind-body technique that involves directing non-judgmental attention to physical sensations across the body. Within a psycho-neuro-immunological framework, mindfulness practice is hypothesized to reduce physiological stress responses, promote autonomic nervous system balance, and downregulate pro-inflammatory pathways.
This randomized controlled trial evaluates the effectiveness of a structured 8-day mindfulness body scan intervention on both biological inflammatory markers and psychological outcomes among tidal flood survivors. Participants recruited from Sayung 1 Primary Health Center will be randomly allocated into two groups:
Background: Recurrent tidal flooding in coastal Sayung, Demak, exposes residents to chronic environmental and socioeconomic stress, contributing to psychological distress and elevated systemic inflammation. Within a psychoneuroimmunological framework, mindfulness practices-specifically the body scan technique-may suppress pro-inflammatory pathways and regulate the hypothalamic-pituitary-adrenal (HPA) axis.
Study Design: This is a randomized controlled trial conducted at Sayung 1 Primary Health Center, Demak. Eligible adult survivors of tidal flooding will be randomly allocated to either the intervention group or the control group.
Intervention \& Control:
Assessments: Baseline and 1-week post-intervention evaluations will be conducted for all participants:
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 75 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care
Behavioral: Mindfulness Body Scan Training
Participants receive standard health monitoring without the mindfulness body scan intervention
A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
Change in Serum Interleukin-6 (IL-6) Levels
Measured from venous blood samples using ELISA to evaluate changes in pro-inflammatory cytokine levels (concentrations reported in pg/mL).
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels
Measured from venous blood samples using ELISA to assess systemic inflammatory responses (concentrations reported in pg/mL)
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Serum C-Reactive Protein (CRP) Levels
Evaluated via laboratory blood analysis as an indicator of acute phase systemic inflammation (concentrations reported in mg/L).
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Serum Cortisol Levels
Measured via venous blood samples to assess HPA axis regulation and physiological stress response (concentrations reported in micro-g/dL).
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Depression Score
Measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, where higher scores indicate greater severity of depression.
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Anxiety Score
Measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 to 21, where higher scores indicate greater severity of anxiety.
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Stress Score
Measured using the Perceived Stress Scale (PSS-10). Scores range from 0 to 40, where higher scores indicate higher levels of perceived stress.
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Sleep Quality Score
Measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, where higher scores indicate worse sleep quality.
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Quality of Life Score
Measured using the 36-Item Short Form Health Survey (SF-36) Physical Component Summary. Scores range from 0 to 100, where higher scores represent better health-related quality of life.
Time frame: Baseline (Day 0) and post-intervention (Day 8)
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.
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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