Post-traumatic Stress DisorderNCT07164261
Progressive Muscle Relaxation Training in Post-traumatic Stress Disorder in Disasters
A study testing progressive muscle relaxation training in people with Post-traumatic Stress Disorder, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the efficacy of Progressive Muscle Relaxation Training (PMRT) in individuals who developed Post-Traumatic Stress Disorder (PTSD) following the February 6 Kahramanmaraş earthquake. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- progressive muscle relaxation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2025to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals affected by the February 6 Kahramanmaraş earthquake.
- Those diagnosed with Post-Traumatic Stress Disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or with a score of 47 or above on the Post-Traumatic Stress Disorder Checklist (PCL-5).
- Aged 18-65 will be included.
Who cannot join
- Individuals affected by disaster types other than the February 6 Kahramanmaraş earthquake (such as war, flood, landslide, etc.)"
- 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 PMRT 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bitlis Eren Universty
Bitlis, Bitlis /merkez, 13000
About this study
Official title: Efficacy of Progressive Muscle Relaxation Training in Individuals With Post-Traumatic Stress Disorder Following the February 6 Kahramanmaraş Earthquake: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the efficacy of Progressive Muscle Relaxation Training (PMRT) in individuals who developed Post-Traumatic Stress Disorder (PTSD) following the February 6 Kahramanmaraş earthquake.
Read the 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.Additionally, various physiotherapy and rehabilitation approaches such as aerobic, respiratory, relaxation, stretching, balance and strengthening exercises can also be used.Progressive muscle relaxation training increases parasympathetic nervous system activity. This is said to reduce anxiety and stress levels and improve sleep quality, resulting in physical and mental relaxation.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- progressive muscle relaxation training
- Keywords
- post-traumatic stress disorder, progressive muscle relaxation training
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PMRT GROUP | Experimental | Progressive muscle relaxation training will be given additionally to individuals in the PMRT group. Receives: Other: progressive muscle relaxation training |
| CONTROL GROUP | No intervention | Individuals in the control group will continue their standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline at 6 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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. The total score ranges from 0 to 100, with higher scores indicating a better quality of life.
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start2 Sep 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The individuals will be divided into two groups: PMRT and Control groups using block randomization.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Arslan, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164261
- Sponsor's protocol ID
- tssb-kgee
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karadasli T, Arslan M. Efficacy of progressive muscle relaxation training in post-traumatic stress disorder after the Kahramanmaras earthquake: a randomized controlled trial. BMC Psychiatry. 2026 Sep 19;26(1):815. doi: 10.1186/s12888-026-08676-9.
PubMed 42907791
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Progressive Muscle Relaxation Training in Individuals With Post-Traumatic Stress Disorder Following the February 6 Kahramanmaraş Earthquake: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07164261
- Acronym / sponsor ID
- tssb-kgee
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- post-traumatic stress disorder, progressive muscle relaxation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to investigate the efficacy of Progressive Muscle Relaxation Training (PMRT) in individuals who developed Post-Traumatic Stress Disorder (PTSD) following the February 6 Kahramanmaraş earthquake.
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.Additionally, various physiotherapy and rehabilitation approaches such as aerobic, respiratory, relaxation, stretching, balance and strengthening exercises can also be used.Progressive muscle relaxation training increases parasympathetic nervous system activity. This is said to reduce anxiety and stress levels and improve sleep quality, resulting in physical and mental relaxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The individuals will be divided into two groups: PMRT and Control groups using block randomization.
| Arm | Type | Receives |
|---|---|---|
| PMRT GROUP | Experimental | Other: progressive muscle relaxation trainingProgressive muscle relaxation training will be given additionally to individuals in the PMRT group. |
| CONTROL GROUP | No intervention | –Individuals in the control group will continue their standard treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals affected by the February 6 Kahramanmaraş earthquake.
- Those diagnosed with Post-Traumatic Stress Disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or with a score of 47 or above on the Post-Traumatic Stress Disorder Checklist (PCL-5).
- Aged 18-65 will be included.
Key exclusion criteria (8 listed)
- Individuals affected by disaster types other than the February 6 Kahramanmaraş earthquake (such as war, flood, landslide, etc.)"
- 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 PMRT training within the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive muscle relaxation trainingProgressive muscle relaxation training will be performed twice a week, each session lasting 20-30 minutes, for a total of 12 sessions over 6 weeks. | Other | PMRT GROUP |
Primary outcome
PTSD Checklist (PCL-5) questionnaire
Time frame: Change from baseline at 6 weeks
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.
Depression Anxiety and Stress Scale-21 (DASS-21)
Time frame: Change from baseline at 6 weeks
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.
3 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline at 6 weeks
Fatigue Severity Scale (FSS)
Time frame: Change from baseline at 6 weeks
Short Form-36 (SF-36) questionnaire
Time frame: Change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 42907791Karadasli T, Arslan M. Efficacy of progressive muscle relaxation training in post-traumatic stress disorder after the Kahramanmaras earthquake: a randomized controlled trial. BMC Psychiatry. 2026 Sep 19;26(1):815. doi: 10.1186/s12888-026-08676-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxation training in people with Post-traumatic Stress Disorder, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL-5) questionnaire (time frame: Change from baseline at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07164261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.