Mindfulness, Woman, Stress, DisasterRCTNCT07283601

A Randomized Controlled Trial of Mindfulness-Based Stress Reduction for Reducing Perceived Stress in Women Impacted by Large-Scale Disasters

A study testing MBSRP in people with Mindfulness, Woman, Stress, Disaster, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hypothesis: Women affected by large-scale disasters who participate in an eight-week Mindfulness-Based Stress Reduction (MBSR) program will experience significantly lower perceived stress levels compared to those in the control group without intervention. Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Mindfulness, Woman, Stress, Disaster
What is being tested?: MBSRP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2023to 1 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female participants aged 18-65 years. Have been directly affected by a large-scale disaster (e.g., earthquake, flood, fire, or similar event) within the past 12-24 months.
Report moderate or high perceived stress levels (Perceived Stress Scale [PSS-10] score ≥ 14).
Able to attend weekly MBSR sessions for 8 consecutive weeks. Willing to provide written informed consent to participate in the study.

Who cannot join

Current diagnosis of severe psychiatric disorder (e.g., psychosis, bipolar disorder, severe major depression).
Ongoing psychotherapy or psychopharmacological treatment for stress, anxiety, or depression at the time of enrollment.
Prior participation in any mindfulness or meditation-based program within the last 6 months.
Presence of a serious medical condition (e.g., uncontrolled hypertension, cardiovascular disease) that could interfere with participation.
Pregnancy or postpartum period (<6 months), if it affects stress levels or participation.
Inability to understand study instructions or complete questionnaires in Turkish.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Muş Alparslan University
Merkez, Muş

Other trials in Turkey (Türkiye)

About this study

Official title: Mindfulness-Based Stress Reduction for Disaster-Affected Women: A Randomized Controlled Trial

Hypothesis:

Women affected by large-scale disasters who participate in an eight-week Mindfulness-Based Stress Reduction (MBSR) program will experience significantly lower perceived stress levels compared to those in the control group without intervention.

Read the detailed description

Objective: This study aims to describe the effect of the Mindfulness-Based Stress Reduction Program (MBSRP) administered in relation to post-disaster stress.

Material and Method: The present study was carried out by using a quasi-experimental design with 35 participants in the intervention group and 33 in the control group. Personal Information Form, Mindful Attention Awareness Scale (MAAS), and Perceived Stress Scale (PSS) were employed in the data collection process. The women in the intervention group underwent an 8-week Mindfulness Stress Reduction Program. Data were collected through pretests and posttests.

Descriptive statistics were used for data analysis. Independent samples t-test and dependent samples t-test were utilized for the control and intervention groups. The relationship between continuous variables was analyzed by using Pearson Correlation analysis.

Conditions: Mindfulness, Woman, Stress, Disaster
Being tested: MBSRP
Keywords: mindfulness, woman, stress, disaster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MBSRPBehavioural
The intervention consists of an 8-week Mindfulness-Based Stress Reduction (MBSR) program designed to reduce perceived stress and promote emotional resilience among disaster-affected women.
Each session will last approximately 2 to 2.5 hours per week, conducted by a certified MBSR instructor in small groups of 10-15 participants.
The program includes:
Mindfulness meditation,
Body scan exercises,
Gentle yoga and stretching,
Breathing awareness and relaxation techniques, and
Group discussions and reflections to integrate mindfulness practices into daily life.
Participants will be asked to complete 30-45 minutes of daily home practice using guided meditation recordings.
The primary goal of the intervention is to decrease perceived stress and enhance psychological well-being among women who have experienced large-scale disasters.

Study groups in NCT07283601
Study group	Role	What they receive
Intervention	Experimental	Participants in the experimental group will receive an 8-week Mindfulness-Based Stress Reduction (MBSR) program designed to reduce perceived stress and enhance emotional resilience. The intervention will consist of: Weekly group sessions (2-2.5 hours each) led by a certified MBSR instructor, Daily home practice (30-45 minutes per day), supported by guided meditation recordings. Each session will include: Mindfulness meditation focused on present-moment awareness, Body scan exercises to enhance bodily awareness, Gentle yoga and stretching, Breathing and relaxation techniques, and Group discussions and reflection to integrate mindfulness into daily life. Participants will be encouraged to maintain a daily mindfulness routine and record their practice in provided logs. Receives: Behavioral: MBSRP
Control	No intervention	Participants assigned to the control group will not receive any intervention during the study period. They will complete the same assessment measures as the experimental group at baseline, post-intervention (week 8), and follow-up (if applicable). This group serves as a comparison to evaluate whether changes in perceived stress are specifically attributable to the Mindfulness-Based Stress Reduction (MBSR) program rather than natural recovery or time effects. After the completion of data collection, participants in the control group will be offered the opportunity to participate in the MBSR program (wait-list control condition) for ethical considerations.

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome Measure: Change in perceived stress level measured by the Perceived Stress Scale (PSS-10) from baseline to week 8
Primary Outcome Title:
Perceived Stress Level
Description:
The primary outcome will be the change in perceived stress levels from baseline to 8 weeks after the intervention.
Measurement Tool:
Perceived Stress Scale (PSS-10), a validated 10-item self-report questionnaire that measures the degree to which situations in one's life are appraised as stressful.
Time Frame:
Baseline (Week 0) and Post-intervention (Week 8)
Scoring and Interpretation:
Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in the mean PSS-10 score from baseline to week 8 in the intervention group compared to the control group will indicate a positive treatment effect.
Type of Outcome:
Continuous variable (mean score difference between groups)
Measured: Baseline (Week 0) - before the start of the intervention Post-intervention (Week 8) - immediately after completion of the 8-week MBSR program Follow-up (Week 12 or Week 16) - four to eight weeks after the intervention to assess maintenance of effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20231 Jun 2023

First posted16 Dec 2025
Study start1 Jun 2023
Primary completion1 Jun 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mindfulness, Woman, Stress, DisasterStudies 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: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07283601
Sponsor's protocol ID: Disaster
Other IDs: Muş Alparslan Universty
Acronym: RCT
Status last verified: Dec 2025
First submitted: 4 Dec 2025
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: IPD Sharing Plan Description: De-identified individual participant data (IPD) that underlie the results reported in this study will be shared upon reasonable request after publication of the main findings. The shared data will include demographic variables, baseline characteristics, outcome measures (e.g., Perceived Stress Scale scores), and intervention adherence information. Data will be available to qualified researchers for secondary analyses that are consistent with the original study objectives. Requests for access must include a methodologically sound proposal and ethical approval. Data will be shared through a secure data repository or institutional data-sharing agreement, ensuring participant confidentiality according to relevant data protection regulations (e.g., GDPR, national ethics standards). Time Frame for Data Sharing: Beginning 6 months after publication of the primary results and available for up to 3 years following that date.

Publications

Sezgin L, Karakaya A, Sahin A, Sahin B, Baltaci Yildiz EA. Stress reduction based on awareness for women affected by disasters: a randomized controlled trial. Psychol Health Med. 2026 Sep 10:1-16. doi: 10.1080/13548506.2026.2728576. Online ahead of print.
PubMed 42720252

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-Based Stress Reduction for Disaster-Affected Women: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07283601
Acronym / sponsor ID: RCT / Disaster
Conditions: Mindfulness, Woman, Stress, Disaster
Keywords: mindfulness, woman, stress, disaster
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Hasan Kalyoncu UniversityUniversity, hospital or other
Study start: 1 Jun 2023 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 16 Dec 2025 (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.

Hypothesis:

Detailed description

Objective: This study aims to describe the effect of the Mindfulness-Based Stress Reduction Program (MBSRP) administered in relation to post-disaster stress.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: MBSRPParticipants in the experimental group will receive an 8-week Mindfulness-Based Stress Reduction (MBSR) program designed to reduce perceived stress and enhance emotional resilience. The intervention will consist of: Weekly group sessions (2-2.5 hours each) led by a certified MBSR instructor, Daily home practice (30-45 minutes per day), supported by guided meditation recordings. Each session will include: Mindfulness meditation focused on present-moment awareness, Body scan exercises to enhance bodily awareness, Gentle yoga and stretching, Breathing and relaxation techniques, and Group discussions and reflection to integrate mindfulness into daily life. Participants will be encouraged to maintain a daily mindfulness routine and record their practice in provided logs.
Control	No intervention	–Participants assigned to the control group will not receive any intervention during the study period. They will complete the same assessment measures as the experimental group at baseline, post-intervention (week 8), and follow-up (if applicable). This group serves as a comparison to evaluate whether changes in perceived stress are specifically attributable to the Mindfulness-Based Stress Reduction (MBSR) program rather than natural recovery or time effects. After the completion of data collection, participants in the control group will be offered the opportunity to participate in the MBSR program (wait-list control condition) for ethical considerations.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female participants aged 18-65 years. Have been directly affected by a large-scale disaster (e.g., earthquake, flood, fire, or similar event) within the past 12-24 months.
Report moderate or high perceived stress levels (Perceived Stress Scale [PSS-10] score ≥ 14).
Able to attend weekly MBSR sessions for 8 consecutive weeks. Willing to provide written informed consent to participate in the study.

Key exclusion criteria (6 listed)

Current diagnosis of severe psychiatric disorder (e.g., psychosis, bipolar disorder, severe major depression).
Ongoing psychotherapy or psychopharmacological treatment for stress, anxiety, or depression at the time of enrollment.
Prior participation in any mindfulness or meditation-based program within the last 6 months.
Presence of a serious medical condition (e.g., uncontrolled hypertension, cardiovascular disease) that could interfere with participation.
Pregnancy or postpartum period (<6 months), if it affects stress levels or participation.

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
MBSRPThe intervention consists of an 8-week Mindfulness-Based Stress Reduction (MBSR) program designed to reduce perceived stress and promote emotional resilience among disaster-affected women. Each session will last approximately 2 to 2.5 hours per week, conducted by a certified MBSR instructor in small groups of 10-15 participants. The program includes: Mindfulness meditation, Body scan exercises, Gentle yoga and stretching, Breathing awareness and relaxation techniques, and Group discussions and reflections to integrate mindfulness practices into daily life. Participants will be asked to complete 30-45 minutes of daily home practice using guided meditation recordings. The primary goal of the intervention is to decrease perceived stress and enhance psychological well-being among women who have experienced large-scale disasters.	Behavioural	Intervention

Primary outcome

Primary Outcome Measure: Change in perceived stress level measured by the Perceived Stress Scale (PSS-10) from baseline to week 8
Time frame: Baseline (Week 0) - before the start of the intervention Post-intervention (Week 8) - immediately after completion of the 8-week MBSR program Follow-up (Week 12 or Week 16) - four to eight weeks after the intervention to assess maintenance of effects
Primary Outcome Title: Perceived Stress Level Description: The primary outcome will be the change in perceived stress levels from baseline to 8 weeks after the intervention. Measurement Tool: Perceived Stress Scale (PSS-10), a validated 10-item self-report questionnaire that measures the degree to which situations in one's life are appraised as stressful. Time Frame: Baseline (Week 0) and Post-intervention (Week 8) Scoring and Interpretation: Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in the mean PSS-10 score from baseline to week 8 in the intervention group compared to the control group will indicate a positive treatment effect. Type of Outcome: Continuous variable (mean score difference between groups)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Derived from this study: PubMed 42720252Sezgin L, Karakaya A, Sahin A, Sahin B, Baltaci Yildiz EA. Stress reduction based on awareness for women affected by disasters: a randomized controlled trial. Psychol Health Med. 2026 Sep 10:1-16. doi: 10.1080/13548506.2026.2728576. Online ahead of print.
Individual participant dataSharing planned: Undecided. IPD Sharing Plan Description: De-identified individual participant data (IPD) that underlie the results reported in this study will be shared upon reasonable request after publication of the main findings. The shared data will include demographic variables, baseline characteristics, outcome measures (e.g., Perceived Stress Scale scores), and intervention adherence information. Data will be available to qualified researchers for secondary analyses that are consistent with the original study objectives. Requests for access must include a methodologically sound proposal and ethical approval. Data will be shared through a secure data repository or institutional data-sharing agreement, ensuring participant confidentiality according to relevant data protection regulations (e.g., GDPR, national ethics standards). Time Frame for Data Sharing: Beginning 6 months after publication of the primary results and available for up to 3 years following that date.

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MBSRP in people with Mindfulness, Woman, Stress, Disaster, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 16 Dec 2025. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure: Change in perceived stress level measured by the Perceived Stress Scale (PSS-10) from baseline to week 8 (time frame: Baseline (Week 0) - before the start of the intervention Post-intervention (Week 8) - immediately after completion of the 8-week MBSR program Follow-up (Week 12 or Week 16) - four to eight weeks after the intervention to assess maintenance of effects). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07283601, which also lists 1 linked publication.

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 16 Dec 2025.