Clinical trial NCT06230133: Feasibility and the Effects of Mindfulness-Based Stress Reduction (MBSR) on College Students
Official title: Feasibility and the Effects of Mindfulness-Based Stress Reduction (MBSR) on College Students' Resilience, Post-traumatic Stress Disorder Symptoms (PTSD) and Posttruamatic Growth (PTG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Symptom
Keywords: military medical students, mindfulness, resilience
Lead sponsor: Army Medical University, China
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study was designed as a controlled trial with a MBSR intervention and an control condition. Psychological data was assessed at baseline, at the end of the intervention, and one month later after the intervention, respectively.
Primary purpose: TREATMENT

Brief summary: The goal of this retrospective control study is to learn about the effects of Mindfulness Based Stress Reduction (MBSR) intervention in military medical students' resilience, post-traumatic stress disorder symptoms (PTSD) and posttruamatic growth (PTG) etc. The main questions are aims to answer:

1. Would MBSR intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？
2. Would MBSR intervention reduce anxiety, depression, and PTSD symptoms in military medical students？
3. Would the effects of MBSR intervention persist for at least one month in military medical students？ Participants in the intervention group will complete 8-week of MBSR training while those in the control group will not. Researchers will compare resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth, etc. between the two groups.

Detailed description: Recruitment for the study was done via broadcast email and posted notices online. 372 students filled out screening questionnaires and indicated their intention to participate the Mindfulness Based Stress Reduction (MBSR) course. We selected 120 students according to the participant criteria. Of the 120 participants, 60 were randomly assigned to the MBSR or control groups. However, 8 participants were absent more than two courses in the MBSR group, and 24 participants did not complete the post-test. Eventually, we enrolled 52 participants in the intervention group and 36 participants in the control group.

We designed a questionnaire survey on the internet to collect data. Two trained psychology teachers organized the survey at three time points: baseline (T0), the immediate postintervention (T1), and 1 month postintervention (T2).

Independent samples t-test and c2 analyses were used to test for possible group differences in demographic variables at baseline (T1).

Next, 2 (group) × 3 (time) mixed-model repeated-measure analysis of variance ( ANOVA) was conducted to determine the effect of MBSR. Effect sizes were reported as partial η² (ηp²) coefficients. To further interpret any time-by-group interactions, a series of t tests examined possible differences among baseline, post intervention and 1 month later after intervention.

Eligibility criteria: Inclusion Criteria:

* No regular meditation and yoga practice within the past 6 months;
* No current psychiatric symptoms and physical contraindications to exercise;
* the resilience scale scores were in the last 27% of the total 372 students.

Exclusion Criteria:

* Unwillingness to participant the mindfulness class;
* Absence from 2 or more classes;
* Do not complete the pre-, post-test and follow-up psychological assessment.

Primary outcomes:
measure: The 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: 12 weeks
measure: The Posttraumatic Growth Inventory (PTG)
timeFrame: 12 weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 12 weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: 12 weeks
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 12 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Army Medical University
Study officials:
affiliation: Department of Military Psychology
name: Peng LI, professor
role: STUDY_DIRECTOR
References: