Mindfulness-based stress reduction for PTSD after road traffic accidents
Mindfulness-based Stress Reduction for Treatment of PTSD in Road Traffic Accident Victims: Evaluating Its Efficacy in a Randomised Controlled Trial
This trial will see if a six-week mindfulness-based stress reduction (MBSR) program helps adults with PTSD from road traffic accidents have fewer PTSD symptoms and better quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Ürümqi, Xinjiang) |
| Trial ID | NCT07521020 on ClinicalTrials.gov |
What this trial studies
Adults who developed PTSD after a road traffic accident and meet DSM-5-TR criteria (PCL-5 ≥31) are randomized to receive either a weekly MBSR session for six weeks plus usual care or treatment-as-usual (TAU). Outcomes including PTSD symptoms, quality of life, and mindfulness are measured with questionnaires at baseline, after the intervention, and at a follow-up time point. The intervention is delivered in person and compared directly against TAU to estimate added benefit of MBSR. The trial excludes people with organic brain injury from the accident, prior other mental illnesses, substance dependence, pregnancy, inability to understand Chinese, or unstable severe medical illness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–60 who developed PTSD after a road traffic accident, hold a traffic-accident ID certificate, have at least a junior-high education, score ≥31 on the PCL-5, and can attend weekly sessions in Chinese.
Not a fit: People with organic brain injury from the accident, preexisting diagnosed mental illnesses, active substance dependence, inability to understand Chinese, pregnancy, or unstable severe medical conditions are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, MBSR could provide a non-drug option that reduces PTSD symptoms and improves quality of life for road traffic accident survivors.
How similar studies have performed: Previous research on mindfulness and MBSR for PTSD has shown some positive effects on symptoms and wellbeing but results are mixed and not yet definitive for traffic-accident populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (a) Possession of a road traffic identification certificate issued by the public security traffic police department; (b) Age 18-60 years; (c) junior high school education or above and full civil capacity; (d) those who meet the diagnostic criteria for PTSD according to DSM-5-TR (Diagnostic and Statistical Manual for Mental Disorder 5th Edition-Text Revised) which occurred after road traffic accident; (e) A score of 31 or above on the PTSD Checklist for DSM-5 (PCL-5) indicating possibility of PTSD in diagnosis; and (f) those taking a stable dose of a single antidepressant for the past 2 weeks and willing to maintain on the dose until the end of the study. Exclusion Criteria: (a) Organic brain damage caused by road traffic accident; (b) A previous diagnosis of any mental illness; (c) Pregnant women; (d) Alcohol and drug dependence and abuse; (e) Inability to understand Chinese; (f) history of severe and unstable medical illnesses that are not suitable for participation in the study; (g) having participated in any psychotherapy before participating in the study, and (h) those with suicidal tendency.
Where this trial is running
Ürümqi, Xinjiang
- Fifth Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
Study contacts
- Study coordinator: Mohammad Farris Iman Leong Bin Abdullah, Doctor of Psychiatry
- Email: farrisiman@unisza.edu.my
- Phone: +60186669950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.