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NCT Number: NCT07790055

The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak

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:

1. Intervention Group: Receives structured 8-day Mindfulness Body Scan training. 2. Control Group: Receives standard health monitoring. All participants will undergo baseline and post-intervention assessments, which include venous blood sampling to analyze key inflammatory and stress biomarkers-Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol. In addition, psychometric instruments will evaluate changes in depression, anxiety, stress, sleep quality, and overall quality of life. The primary objective is to determine whether a short-term mindfulness body scan practice can effectively reduce systemic inflammation and improve post-disaster psychological well-being in coastal communities.

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Key information

Conditions

Psychological Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression - Major Depressive Disorder Disaster Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stress, Psychological

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Sayung 1

Demak, Central Java, Indonesia

About this study

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:

  • Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
  • Control Group: Receives standard health monitoring.

Assessments: Baseline and 1-week post-intervention evaluations will be conducted for all participants:

  • Biomarkers: Venous blood samples to analyze Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol.
  • Psychometric Assessments: Standardized questionnaires evaluating depression, anxiety, stress, sleep quality, and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Resident of Sayung District, Demak Regency, affected by tidal flooding (rob).
  • Registered patient at Sayung 1 Primary Health Center.
  • Capable of providing written informed consent and participating in the intervention sessions.

Exclusion criteria

  • Severe cognitive impairment, active psychosis, or severe psychiatric conditions preventing participation.
  • Uncontrolled systemic autoimmune or inflammatory diseases.
  • Current use of long-term systemic corticosteroid or immunosuppressive therapy.
  • Inability to complete questionnaires or follow basic mindfulness instructions.

Treatment and study plan

Mindfulness Body Scan Training

Behavioral

A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe

Primary outcomes

  1. Change in Serum Interleukin-6 (IL-6) Levels

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured from venous blood samples using ELISA to evaluate changes in pro-inflammatory cytokine levels (concentrations reported in pg/mL).

  2. Change in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured from venous blood samples using ELISA to assess systemic inflammatory responses (concentrations reported in pg/mL)

  3. Change in Serum C-Reactive Protein (CRP) Levels

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Evaluated via laboratory blood analysis as an indicator of acute phase systemic inflammation (concentrations reported in mg/L).

  4. Change in Serum Cortisol Levels

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured via venous blood samples to assess HPA axis regulation and physiological stress response (concentrations reported in micro-g/dL).

Secondary outcomes

  1. Change in Depression Score

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, where higher scores indicate greater severity of depression.

  2. Change in Anxiety Score

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    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.

  3. Change in Stress Score

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured using the Perceived Stress Scale (PSS-10). Scores range from 0 to 40, where higher scores indicate higher levels of perceived stress.

  4. Change in Sleep Quality Score

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    Measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, where higher scores indicate worse sleep quality.

  5. Change in Quality of Life Score

    Time frame: Baseline (Day 0) and post-intervention (Day 8)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Dewi Wardani Dr. dr. Sp.KJ(K)

CONTACT

[email protected]

+6281325683134

Sponsors and collaborators

Lead sponsor

Natalia Dewi Wardani, MD

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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