Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

NCT07563556 | Not Yet Recruiting

• 1 other identifier: 2026-231
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether a 4-week program called "Combined Mind-Body Intervention" can help survivors of the February 6, 2023, earthquakes manage stress and improve their ability to participate in daily activities. The study specifically aims to answer the following question: Does a program combining guided imagery and progressive muscle relaxation lead to significant, long-term improvements in occupational performance (self-care, work, and leisure), reduced stress levels, and better overall quality of life for earthquake survivors when compared to a control group? The study will involve: Target Population: Adults aged 18 to 65 who directly experienced the 2023 earthquakes and currently reside in the affected region .Intervention: Participants in the intervention group will attend eight individual sessions (twice a week) focusing on deep breathing, step-by-step muscle relaxation, and guided visualization of peaceful environments. Evaluation: Changes in stress, mood, and daily activity performance will be measured at the beginning of the study, at the end of the 4-week program, and during a 6-month follow-up period to determine the lasting effects of the intervention.

Conditions

Earthquake Victim

Keywords

earthquake victim; occupational therapy; mind-body intervention; occupational performance

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores

  The COPM is a semi-structured interview used to identify and prioritize issues in occupational performance. Participants rate their perceived performance and satisfaction for their top five identified problem areas in daily activities (self-care, productivity, and leisure). Both scales use a 10-point Likert scale ranging from 1 ("not able to do it" or "not satisfied") to 10 ("able to do it extremely well" or "extremely satisfied") . Higher scores indicate better occupational performance and higher satisfaction.

  Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)

  Baseline, Week 4, and Month 6.

• Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)

  Baseline, Week 4, and Month 6.

• Nottingham Health Profile (NHP) Domain Scores

  Baseline, Week 4, and Month 6.

Study Arms (2)

Combined Mind-Body Intervention

EXPERIMENTAL

his group receives 8 individual sessions, conducted twice weekly for 30 to 40 minutes.Each session consists of Jacobson's progressive muscle relaxation and guided imagery techniques.Participants are also instructed to perform daily home practice

Other: combined mind-body intervention

Control Group (Routine Care & Monitoring)

ACTIVE COMPARATOR

Participants receive routine care along with supplemental support.They will be contacted by phone twice a week for 4 weeks by the investigator to monitor their general health status.The phone calls are limited to general status inquiries to minimize bias related to investigator attention.

Behavioral: Routine Care and Follow-up Phone Calls

Interventions

combined mind-body intervention OTHER

The intervention consists of 8 individual sessions (30-40 mins, twice weekly) combining Jacobson's Progressive Muscle Relaxation (PMR) and Guided Imagery. Sessions begin with 5 minutes of diaphragmatic breathing. PMR involves 15 minutes of tensing and relaxing specific muscle groups (limbs, face, trunk) to reduce physical tension. This is followed by 15 minutes of Guided Imagery, visualizing sensory-rich "safe places" (e.g., childhood gardens) to promote emotional regulation. Participants perform 15-minute daily home practice. Sessions take place in a quiet, dimly lit environment with relaxing music. For physiological standardization, participants avoid caffeine, nicotine, and food one hour before. This occupational therapy protocol aims to enhance participation in daily activities (self-care, work, leisure) and reduce stress levels

Combined Mind-Body Intervention

Routine Care and Follow-up Phone Calls BEHAVIORAL

Participants receive their standard routine care. Additionally, they will be contacted by phone twice a week for 4 weeks by the primary investigator to inquire about their general health and well-being. These calls are limited to status inquiries to ensure that any observed changes in the study are due to the intervention itself rather than the attention provided by the researcher.

Control Group (Routine Care & Monitoring)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between 18 and 65 years old.
• Having directly experienced the February 6, 2023 earthquake.
• Currently residing in the earthquake zone.
• Possessing sufficient cognitive and language skills to participate in assessments and the intervention.

You may not qualify if:

• Having an additional psychiatric or neurological disease diagnosis.
• Having received non-pharmacological interventions (such as psychotherapy, CBT, art therapy, or meditation) before or during the study.
• Currently using psychiatric medications.
• Having a history of other physical (e.g., violence) or psychological trauma.
• Being pregnant or currently breastfeeding.
• Having a current substance addiction.
• Demonstrating suicidal tendencies.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

Emine Sağlamoğlu, Master

CONTACT

+905388749386; eminesaglamoglu@gmail.com

gamze ekici, professor

CONTACT

+903123052560; fztgamze@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant/ MSc OT

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 4, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

TU (1)