THE EFFECT OF MINDFULNESS IN INFLAMMATION MARKERS (IL-6, TNF-Α, CRP AND CORTISOL) AMONG SURVIVORS OF TIDAL FLOODING IN SAYUNG DEMAK

NCT07790055 | Not Yet Recruiting DMC

• 1 other identifier: FK-UNDIP-MIND-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
2. 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.

Conditions

Psychological Stress; Depression - Major Depressive Disorder; Anxiety; Inflammation; Disaster

Keywords

psychological stress; anxiety; mindfulness; tidal flooding; depression

Outcome Measures

Primary Outcomes (4)

• Change in Serum Interleukin-6 (IL-6) Levels

  Measured from venous blood samples using ELISA to evaluate changes in pro-inflammatory cytokine levels.

  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.

  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.

  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.

  Baseline (Day 0) and post-intervention (Day 8)

Secondary Outcomes (1)

• Change in Psychological Distress, Sleep Quality, and Quality of Life Scores

  Baseline (Day 0) and post-intervention (Day 8)

Study Arms (2)

Mindfulness Body Scan

EXPERIMENTAL

Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care

Behavioral: Mindfulness Body Scan Training

Control Group

NO INTERVENTION

Participants receive standard health monitoring without the mindfulness body scan intervention

Interventions

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

Mindfulness Body Scan

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natalia Dewi Wardani, MD: lead

Study Sites (1)

Puskesmas Sayung 1

Demak, Central Java, Indonesia

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Inflammation; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+6281325683134; anatdew@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Psychiatry Residency Program Medical Faculty Diponegoro University, Principal Investigator

Model Details: Participants meeting inclusion criteria are randomly assigned to either an 8-day Mindfulness Body Scan intervention or standard monitoring control.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)