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Not yet recruiting NCT07563556

Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

No phase Interventional Earthquake Victim

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: combined mind-body intervention, Routine Care and Follow-up Phone Calls.
Who it may be relevant to
Registry conditions: Earthquake Victim. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Examining the Effect of Combined Mind-body Intervention in Earthquake Survivors: A 6 Months Follow-up Randomized Controlled Trial

Overview

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.

Interventions

  • Other combined mind-body intervention
    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 perfor
  • Behavioral Routine Care and Follow-up Phone Calls
    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.

Primary outcome measures

  • Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores [Time frame: Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.]
Secondary outcome measures (3)
  • Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A) [Time frame: Baseline, Week 4, and Month 6.]
  • Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D) [Time frame: Baseline, Week 4, and Month 6.]
  • Nottingham Health Profile (NHP) Domain Scores [Time frame: Baseline, Week 4, and Month 6.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Ankara

Identifiers

NCT: NCT07563556 · 2026-231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗