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Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

29. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

26

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Annen: 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
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

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Sponsor

Hacettepe University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. april 2026

Primær fullføring (Antatt)

30. mai 2026

Studiet fullført (Antatt)

30. november 2026

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2026-231

Plan for individuelle deltakerdata (IPD)

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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