CompletedNot Applicable

Mindfulness-based Stress Reduction for PTSD in Road Traffic Accident Victims: A Randomized Controlled Trial

China110 participantsStarted 2025-04-01

Plain-language summary

The goals of the study are to investigate the effects of mindfulness-based stress reduction (MBSR) on PTSD among road traffic accident victims. The main questions are: does MBSR exerts any effects on PTSD symptoms, quality of life and mindfulness? Researchers will compare effects of MBSR with TAU on PTSD symptoms, quality of life and mindfulness. Participants will be: * administered few questionnaires at three time points * administered MBSR once a week session for 6 weeks

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Posttraumatic Stress Disorder Checklist for DSM-5

Timeframe: Change in mean total score from baseline to post-intervention (8 weeks after intervention commence or immediately after completion of intervention) and from post-intervention to follow-up (12 weeks after completion of intervention)

Trial details

NCT IDNCT07521020

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Posttraumatic Stress Disorder (PTSD) trials