Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
ConditionEarthquake Victim
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
combined mind-body intervention
Other interventionThe 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
Routine Care and Follow-up Phone Calls
BehavioralParticipants 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.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Combined Mind-Body InterventionExperimental treatment 1 intervention
Group B: Control Group (Routine Care & Monitoring)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.Secondary outcomes
1
Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
This 7-item sub-scale specifically measures anxiety levels. Scores range from 0 to 21. Higher scores indicate greater anxiety; lower scores reflect clinical improvement.
Time frame
Baseline, Week 4, and Month 6.2
Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)
This 7-item sub-scale specifically measures depression levels. Scores range from 0 to 21. Higher scores indicate more severe depression; lower scores reflect clinical improvement.
Time frame
Baseline, Week 4, and Month 6.3
Nottingham Health Profile (NHP) Domain Scores
Separate assessment of six domains: Physical Mobility (8 items), Pain (8 items), Sleep (5 items), Energy Level (3 items), Emotional Reactions (9 items), and Social Isolation (5 items). Each domain is scored from 0 to 100. Higher scores represent more severe problems in that specific area of health.
Time frame
Baseline, Week 4, and Month 6.Sponsors and contacts
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Source ClinicalTrials.gov
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