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Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

29 april 2026 bijgewerkt door: Emine Sağlamoğlu, Hacettepe University

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

26

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Combined Mind-Body Intervention
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
Ander: 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 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
Actieve vergelijker: Control Group (Routine Care & Monitoring)
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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
Tijdsspanne: Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
Tijdsspanne: Baseline, Week 4, and Month 6.
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.
Baseline, Week 4, and Month 6.
Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)
Tijdsspanne: Baseline, Week 4, and Month 6.
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.
Baseline, Week 4, and Month 6.
Nottingham Health Profile (NHP) Domain Scores
Tijdsspanne: Baseline, Week 4, and Month 6.
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.
Baseline, Week 4, and Month 6.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 april 2026

Primaire voltooiing (Geschat)

30 mei 2026

Studie voltooiing (Geschat)

30 november 2026

Studieregistratiedata

Eerst ingediend

21 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

29 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2026-231

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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