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Clinical Trial NCT07164261 for Post-traumatic Stress Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Progressive Muscle Relaxation Training in Post-traumatic Stress Disorder in Disasters 50

Recruiting
Clinical Trial NCT07164261 is an interventional study for Post-traumatic Stress Disorder that is recruiting. It started on September 2, 2025 with plans to enroll 50 participants. Led by Bitlis Eren University, it is expected to complete by September 2, 2026. The latest data from ClinicalTrials.gov was last updated on September 15, 2025.
Brief Summary
This study aims to investigate the effectiveness of progressive muscle relaxation training in disaster victims experiencing post-traumatic stress disorder.
Detailed Description
Post-traumatic stress disorder (PTSD) is an often devastating psychiatric condition that can occur in people who experience or witness a traumatic event.The estimated lifetime prevalence of PTSD is reported to be 6.8%.While trauma-focused psychotherapy is generally the first-line treatment in PTSD management, pharmacological treatments (selective serotonin reuptake inhibitors) are recommended in second-line treatment...Show More
Official Title

Effectiveness of Progressive Muscle Relaxation Training in Disaster Victims With Post-traumatic Stress Disorder: a Randomized Controlled Study

Conditions
Post-traumatic Stress Disorder
Other Study IDs
  • tssb-kgee
NCT ID Number
NCT07164261
Start Date (Actual)
2025-09-02
Last Update Posted
2025-09-15
Completion Date (Estimated)
2026-09-02
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
post-traumatic stress disorder
progressive muscle relaxation training
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPKGE GROUP
Progressive muscle relaxation training will be given additionally to individuals in the PKGE group.
progressive muscle relaxation training
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.
No InterventionCONTROL GROUP
Individuals in the control group will continue their standard treatment.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pittsburgh Sleep Quality Index (PSQI)
It is a 19-item index, valid and reliable in Turkish, that assesses individuals' sleep quality and disturbances over the past month. The index's 18 scored questions consist of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleeping pill use, and daytime dysfunction. Each component is scored on a 0-3 scale, with a total score ranging from 0 to 21. A total PSQI score greater than 5 indicates inadequate sleep quality, while scores of 6-10 indicate poor sleep, and scores of 11 or higher indicate long-term sleep disturbance.
Change from baseline at 6 weeks
Fatigue Severity Scale (FSS)
It is a nine-item scale, valid and reliable in Turkish, that assesses individuals' fatigue levels. Individuals score each item on a scale of 1 to 7 (1 = completely disagree, 7 = completely agree). The total scale score ranges from 0 to 63, with scores of 36 and above indicating severe fatigue.
Change from baseline at 6 weeks
Short Form-36 (SF-36) questionnaire
It is a valid and reliable questionnaire in Turkish that assesses individuals' quality of life. It consists of 36 questions and eight subscales: physical function, physical role, emotional role, pain, vitality, general health, and mental health. The total score ranges from 0 to 100, with higher scores indicating a better quality of life.
Change from baseline at 6 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Bitlis Eren University logoBitlis Eren University
Study Responsible Party
Mesut Arslan, Principal Investigator, assistant professor, Bitlis Eren University
Study Central Contact
Contact: Tuğba karadaşlı, 05376059436, [email protected]
1 Study Locations in 1 Countries

Bitlis /merkez

Bitlis Eren Universty, Bitlis, Bitlis /merkez, 13000, Turkey (Türkiye)
tuğba karadaşlı, Contact, 05376059436, [email protected]
Recruiting