NCT07164261

Brief Summary

This study aims to investigate the effectiveness of progressive muscle relaxation training in disaster victims experiencing post-traumatic stress disorder.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

September 2, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 2, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

post-traumatic stress disorderprogressive muscle relaxation training

Outcome Measures

Primary Outcomes (2)

  • PTSD Checklist (PCL-5) questionnaire

    This is a 20-question questionnaire, valid and reliable in Turkish, that assesses PTSD symptoms as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Questions are scored from 0 to 4, and the total score ranges from 0 to 80. A score of 47 or higher indicates the presence of PTSD.

    Change from baseline at 6 weeks

  • Depression Anxiety and Stress Scale-21 (DASS-21)

    It assesses an individual's condition over the past week. It is a 21-question survey consisting of three subscales: depression, anxiety, and stress. A high score on the scale indicates the presence and severity of depression, anxiety, and stress.

    Change from baseline at 6 weeks

Secondary Outcomes (3)

  • Pittsburgh Sleep Quality Index (PSQI)

    Change from baseline at 6 weeks

  • Fatigue Severity Scale (FSS)

    Change from baseline at 6 weeks

  • Short Form-36 (SF-36) questionnaire

    Change from baseline at 6 weeks

Study Arms (2)

PKGE GROUP

EXPERIMENTAL

Progressive muscle relaxation training will be given additionally to individuals in the PKGE group.

Other: progressive muscle relaxation training

CONTROL GROUP

NO INTERVENTION

Individuals in the control group will continue their standard treatment.

Interventions

Progressive muscle relaxation training will be performed twice a week, each session lasting 20-30 minutes, for a total of 12 sessions over 6 weeks.

PKGE GROUP

Eligibility Criteria

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

You may qualify if:

  • Individuals affected by disasters
  • Those diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
  • Aged 18-65 will be included

You may not qualify if:

  • Individuals with uncontrolled comorbidities accompanying PTSD (such as diabetes or hypertension)
  • serious psychological disorders (such as dementia, psychosis/manic episodes)
  • musculoskeletal conditions that would interfere with exercise training
  • received PKGE training within the last year
  • pregnant
  • have substance abuse
  • have communication difficulties, and are unable to use technology for telerehabilitation will not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren Universty

Bitlis, Bitlis /merkez, 13000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Tuğba karadaşlı

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The individuals will be divided into two groups: PGDI and Control groups using block randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 10, 2025

Study Start

September 2, 2025

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations