Psychological StressNCT07790055
The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak
A study testing Mindfulness Body Scan Training in people with Psychological Stress and Depression - Major Depressive Disorder, run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety
- What is being tested?
- Mindfulness Body Scan Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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:
- Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
- 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.
Read the detailed description
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.
- Conditions
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety, Inflammation, Disaster
- Being tested
- Mindfulness Body Scan Training
- Keywords
- psychological stress, anxiety, mindfulness, tidal flooding, depression
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Inflammation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Body Scan TrainingBehavioural
A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Body Scan | Experimental | Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care Receives: Behavioral: Mindfulness Body Scan Training |
| Control Group | No intervention | Participants receive standard health monitoring without the mindfulness body scan intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Baseline (Day 0) and post-intervention (Day 8)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and post-intervention (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants meeting inclusion criteria are randomly assigned to either an 8-day Mindfulness Body Scan intervention or standard monitoring control.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalia Dewi Wardani, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natalia Dewi Wardani, MD, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790055
- Sponsor's protocol ID
- FK-UNDIP-MIND-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak
- ClinicalTrials.gov ID
- NCT07790055
- Acronym / sponsor ID
- FK-UNDIP-MIND-01
- Conditions
- Psychological Stress, Depression - Major Depressive Disorder, Anxiety, Inflammation, Disaster
- Keywords
- psychological stress, anxiety, mindfulness, tidal flooding, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Natalia Dewi Wardani, MDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants meeting inclusion criteria are randomly assigned to either an 8-day Mindfulness Body Scan intervention or standard monitoring control.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Body Scan | Experimental | Behavioral: Mindfulness Body Scan TrainingParticipants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care |
| Control Group | No intervention | –Participants receive standard health monitoring without the mindfulness body scan intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Body Scan TrainingA structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe | Behavioural | Mindfulness Body Scan |
Primary outcome
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).
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)
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).
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).
5 secondary outcomes
Change in Depression Score
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Anxiety Score
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Stress Score
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Sleep Quality Score
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Change in Quality of Life Score
Time frame: Baseline (Day 0) and post-intervention (Day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Body Scan Training in people with Psychological Stress and Depression - Major Depressive Disorder, run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Dewi Wardani Dr. dr. Sp.KJ(K) (+6281325683134, anatdew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Interleukin-6 (IL-6) Levels (time frame: Baseline (Day 0) and post-intervention (Day 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.