NCT07781904

Brief Summary

This randomized controlled study evaluated whether a structured program combining psychoeducation, breathing exercises, and relaxation techniques could reduce post-traumatic stress symptoms and improve sleep quality among adult earthquake survivors living in temporary accommodation in Malatya, Türkiye. A total of 90 participants were randomly assigned in equal numbers to an intervention group or a control group. The intervention group attended six face-to-face group sessions delivered twice weekly over three weeks. The program included education about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. The control group received no structured intervention and continued its usual daily routine. Post-traumatic stress symptoms and sleep quality were assessed before and after the intervention using the Post-Traumatic Stress Disorder Short Scale and the Pittsburgh Sleep Quality Index. The study compared changes in these outcomes between the intervention and control groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Earthquake SurvivorsPsychoeducationBreathing ExercisesRelaxation TechniquesDiaphragmatic BreathingProgressive Muscle RelaxationPost-Traumatic Stress SymptomsSleep Quality

Outcome Measures

Primary Outcomes (2)

  • Change in Post-Traumatic Stress Symptoms Assessed by the PTSD-SS

    Post-traumatic stress symptoms were assessed using the 9-item Post-Traumatic Stress Disorder Short Scale (PTSD-SS). Each item is scored from 0 to 4, producing a total score ranging from 0 to 36. Higher scores indicate more severe post-traumatic stress symptoms. Change from baseline to the post-intervention assessment was evaluated.

    Baseline and immediately after the 3-week intervention

  • Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of seven component scores and produces a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and scores above 5 indicate poor sleep quality. Change from baseline to the post-intervention assessment was evaluated.

    Baseline and immediately after the 3-week intervention

Study Arms (2)

Psychoeducation-Supported Breathing and Relaxation

EXPERIMENTAL

Participants received six face-to-face group sessions over three weeks, with two sessions per week. The program included psychoeducation about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice.

Behavioral: Psychoeducation-Supported Breathing and Relaxation Program

Control Group

NO INTERVENTION

Participants received no structured training or study intervention and continued their usual daily routines in the temporary accommodation center during the study period.

Interventions

Participants attended six face-to-face group sessions delivered twice weekly over three weeks. Each session lasted approximately 60-75 minutes. The program included psychoeducation about trauma and stress responses, diaphragmatic breathing with approximately 4 seconds of inhalation and 6-8 seconds of exhalation, progressive muscle relaxation, adaptive coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and relapse-prevention guidance. Participants were encouraged to practice diaphragmatic breathing for at least 10 minutes daily and to use the relaxation techniques before sleep. Make-up sessions were offered when necessary.

Psychoeducation-Supported Breathing and Relaxation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experienced the February 6, 2023 earthquakes
  • Aged 18 to 65 years
  • Able to read and understand Turkish
  • Provided written informed consent to participate

You may not qualify if:

  • Incomplete or invalid questionnaires
  • Inability to attend the intervention sessions regularly
  • Self-reported history of a severe psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Teknokent Temporary Accommodation Center

Malatya, 44330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start

October 11, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article will be shared. These data may include relevant sociodemographic and earthquake-related characteristics, group assignment, and baseline and post-intervention PTSD-SS and PSQI scores. Direct personal identifiers will not be shared.

Time Frame
Beginning after publication of the study results and ending 5 years after publication.
Access Criteria
De-identified data will be available to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators and must be consistent with participant confidentiality, informed consent, and applicable ethical requirements. Approved data will be provided electronically for the purposes specified in the accepted proposal. Requests should be submitted to the corresponding author at rana.ceviz@ozal.edu.tr

Locations