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

NCT07521020 | Recruiting DMC

• 1 other identifier: UniSZA 1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSD; randomized controlled trials; quality of life; mindfulness; mindfulness based stress reduction

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Stress Disorder Checklist for DSM-5

  The PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) is currently one of the most commonly used self-assessment scales for evaluating symptoms of post-traumatic stress disorder (PTSD). It corresponds to the diagnostic criteria in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is suitable for clinical assessment and research purposes. The scale is scored using a five-point scale ranging from 'not at all' to 'extremely severe', with a score range of 0 to 4(Weathers et al,2013). PCL-5 can not only be used to assess current PTSD symptoms, but also as a pre- and post-treatment monitoring tool to track changes in symptoms. The Chinese version of the PCL-5 scale was validated in a Chinese PTSD patient population, and showed excellent internal consistency with a Cronbach's α coefficient of 0.90 (Zhao et al,2017).

  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)

Secondary Outcomes (2)

• World Health Organization Quality of Life-Brief (WHOQoL-BREF)

  Change of 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)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Change of 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)

Study Arms (2)

Mindfulness-based stress reduction group

EXPERIMENTAL

The intervention in the MBSR group will be carried out as group therapy in a 2.5 hours (with 45 minutes home assignment) once a week session for 8 weeks. Home assignments will be provided at the end of each session. The acceptable number of sessions attended is at least six sessions, whereby those who attended less than that is considered to have insufficient intervention sessions.

Behavioral: mindfulness-based stress reduction

Control Group

NO INTERVENTION

In the TAU control group, it will be carried out as group therapy in a 2.5 hours (with 45 minutes home assignment) once a week session for 8 weeks. Home assignments will be provided at the end of each session. Non-specific and non-therapeutic components will be explained to participants. The acceptable number of sessions attended is at least six sessions, whereby those who attended less than that is considered to have insufficient intervention sessions.

Interventions

mindfulness-based stress reduction BEHAVIORAL

1. Waking up from "automatic pilot" (session 1) 2. Keeping the body in mind (session 2 and 3) 3. Gathering the scattered mind (session 4) 4. Recognizing reactivity (session 5 and 6) 5. Realizing thoughts are not facts (session 7) 6. How could I best take care of myself? (session 8)

Mindfulness-based stress reduction group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Universiti Sultan Zainal Abidin: collaborator
• Universiti Sains Malaysia: lead
• Xinjiang Medical University: collaborator
• Jinzhou Medical University: collaborator

Study Sites (1)

Fifth Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mohammad Farris Iman Leong Bin Abdullah, Doctor of Psychiatry

CONTACT

+60186669950; farrisiman@unisza.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: statisticians that analysed the data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: August 1, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)