Feasibility and the Effects of Mindfulness-Based Stress Reduction (MBSR) on College Students

NCT06230133 | Completed DMC

• 1 other identifier: ArmyMedChina
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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. 1.Would MBSR intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？
2. 2.Would MBSR intervention reduce anxiety, depression, and PTSD symptoms in military medical students？
3. 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.

Conditions

Posttraumatic Stress Symptom

Keywords

military medical students, mindfulness, resilience

Outcome Measures

Primary Outcomes (7)

• The 10-item Connor-Davidson Resilience Scale (CD-RISC-10)

  Item of CD-RISC-10 responses range from 0 ("not true at all") to 4 ("true nearly all of the time"). The overall score ranges from 0 to 40, with higher scores reflecting a greater ability to cope with adversity. The CD-RISC-10 showed excellent internal consistency in the current study, with Cronbach's alpha coefficients of 0.79, 0.87, and 0.92 at T0, T1, and T2, respectively.

  12 weeks

• The Posttraumatic Growth Inventory (PTG)

  The Posttraumatic Growth Inventory (PTG) was developed to determine the positive changes that occur as a result of the traumatic events experienced by individuals. Participants were asked to rate the degree to which they experienced the change described by each item. The scale consists of 21 items in total and uses a 6-point Likert-type response scale ranging from 0 (almost never) to 5 (almost always). The total score ranged from 0 to 105, and the higher the score, the higher the level of PTG. Cronbach's Alpha for the total PTGI score was α = 0.95, 0.96, and 0.97 at T0, T1, and T2, respectively.

  12 weeks

• Satisfaction with Life Scale (SWLS)

  In this study, life satisfaction was evaluated with the Satisfaction with Life Scale (SWLS). It consists of 5 items and each of them was rated on a 7-point Likert-type scale (1 = strongly disagree; 7 = strongly agree), and higher scores indicate higher life satisfaction. The Cronbach's α of the SWLS in this study was 0.84, 0.88, and 0.89 at T0, T1, and T2, respectively.

  12 weeks

• Mindful Attention Awareness Scale (MAAS)

  Mindful Attention Awareness Scale (MAAS) is a self-reported questionnaire to assess dispositional mindfulness characterized by"open or receptive awareness of and attention" to the present moment. We used the Chinese version of the MAAS revised by Deng et al.. The MAAS included 15 items rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never). The total score ranged from 15 - 90, with higher scores indicating higher levels of mindfulness. The Cronbach's α of the MAAS in this study was 0.91, 0.91, and 0.95 at T0, T1, and T2, respectively.

  12 weeks

• Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  PTSD symptoms were assessed by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) \[33\]. We adopted a revised Chinese version \[34\]in this study. 20 items assess the frequency and severity of PTSD symptoms regarding the index trauma, including symptom clusters of intrusion (Criterion B; 5 items), avoidance (Criterion C; 2 items), negative alterations of cognitions and mood (Criterion D; 7 items), and alterations in arousal and reactivity (Criterion E; 6 items). Participants indicated how much they have been bothered by each symptom using a 5-point scale from 0 (not at all) to 4 (extremely). Total scores range from 0 to 80, with a higher score indicating a greater level of posttraumatic stress. The total score ≥ 33 is considered positive. Cronbach's Alpha for the total PCL-5 in this study was 0.94, 0.93, and 0.96 at T0, T1, and T2, respectively.

  12 weeks

• Generalized Anxiety Disorder Scale (GAD-7)

  Participants' anxiety was measured by the Generalized Anxiety Disorder Scale (GAD-7). It contains 7 items which drawn from the diagnostic criteria for GAD that had the strongest predictive validity with GAD as diagnosed by clinician interviews in a sample of 2740 patients across 15 clinics in the USA. Each item of GAD ranges from 0 (not at all) to 3 (nearly every day) and the total scores range from 0 to 21. A GAD-7 \> 14 has been shown to have severe anxiety. Cronbach's Alpha for GAD-7 in this study was 0.89, 0.90, and 0.95 at T0, T1, and T2, respectively.

  12 weeks

• Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire (PHQ-9) was used to assess depression severity. The scale contains 9 items. Response options for each item of the PHQ-9 score can range from 0 (not at all) to 3 (nearly every day). PHQ-9 total scores range from 0 to 27. A PHQ-9 score \> 10 has been shown to have a sensitivity and specificity of 88% for major depression. Cronbach's Alpha for PHQ-9 in this study was 0.85, 0.87 and 0.89 at T0, T1, and T2, respectively.

  12 weeks

Study Arms (2)

mindfulness based stress reduction (MBSR) intervention

EXPERIMENTAL

MBSR intervention include 8 sessions. Each session took place once a week, 2 h per session, and lasted 8 consecutive weeks. Each session covered specific exercises and topics within the context of mindfulness practice and training. Participants were required to attend at least seven out of eight lessons, and to practice MBSR at least once per day as the homework. We provided participants with a series of audio recordings of MBSR exercises to help them do better. Participants were required to hand in the records of homework assignments before each intervention session, and they shared and discussed their homework assignments with other partners at the beginning of the intervention session. Additionally, the authors encouraged practitioners to develop an ability to bring mindfulness into the varied circumstances of daily living (e.g. Mindful running, mindful eating, mindful walking, and even mindful talking), especially stressful situations.

Behavioral: MBSR intervention

Control condition

NO INTERVENTION

Participants in the control condition received university medical courses and physical training as usual.

Interventions

MBSR intervention BEHAVIORAL

In our study, it is the same to arm description.

mindfulness based stress reduction (MBSR) intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Army Medical University, China: lead

Study Sites (1)

Army Medical University

Chongqing, 400037, China

Location

Study Officials

• Peng LI, professor

  Department of Military Psychology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 30, 2024
• Study Start: February 25, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)