NCT07796919

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Psychological StressDepression - Major Depressive DisorderAnxietyPost-traumatic Stress SymptomsInflammationSurvivor

Keywords

MindfulnessMLRNLRPLRStressAnxietyDepressionFlood

Outcome Measures

Primary Outcomes (6)

  • Change in Monocyte-to-Lymphocyte Ratio (MLR)

    Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.

    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

    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.

    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.

    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.

    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.

    Baseline and Day 8 (post-intervention)

Secondary Outcomes (4)

  • Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Baseline and Day 8 (post-intervention)

  • Change in Connor-Davidson Resilience Scale (CD-RISC) Score

    Baseline and Day 8 (post-intervention)

  • Change in Impact of Event Scale-Revised (IES-R) Score

    Baseline and Day 8 (post-intervention)

  • Change in WHOQOL-BREF Score

    Baseline and Day 8 (post-intervention)

Study Arms (1)

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.

Behavioral: Mindfulness Body Scan

Interventions

Mindfulness Body ScanBEHAVIORAL

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.

Mindfulness Body Scan Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Sayung 1

Demak, Central Java, Indonesia

Location

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersInflammationDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+6281325683134anatdew@gmail.com

Study Design

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

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

ID(1)