Posttraumatic Stress SymptomNCT06230133
Feasibility and the Effects of Mindfulness-Based Stress Reduction (MBSR) on College Students
A study testing MBSR intervention in people with Posttraumatic Stress Symptom, run by Army Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Symptom
- What is being tested?
- MBSR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unwillingness to participant the mindfulness class;
- Absence from 2 or more classes;
- Do not complete the pre-, post-test and follow-up psychological assessment.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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:
- Would MBSR intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？
- Would MBSR intervention reduce anxiety, depression, and PTSD symptoms in military medical students？
- 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.
Read the 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.
- Conditions
- Posttraumatic Stress Symptom
- Being tested
- MBSR intervention
- Keywords
- military medical students, mindfulness, resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR interventionBehavioural
In our study, it is the same to arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MBSR intervention |
| Control condition | No intervention | Participants in the control condition received university medical courses and physical training as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start25 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofan Yan, Army Medical University, China
- Investigators
- Peng LI, professor, Study director, Department of Military Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230133
- Sponsor's protocol ID
- ArmyMedChina
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06230133
- Acronym / sponsor ID
- ArmyMedChina
- Conditions
- Posttraumatic Stress Symptom
- Keywords
- military medical students, mindfulness, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Would MBSR intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？
- Would MBSR intervention reduce anxiety, depression, and PTSD symptoms in military medical students？
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mindfulness based stress reduction (MBSR) intervention | Experimental | Behavioral: MBSR interventionMBSR 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. |
| Control condition | No intervention | –Participants in the control condition received university medical courses and physical training as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Unwillingness to participant the mindfulness class;
- Absence from 2 or more classes;
- Do not complete the pre-, post-test and follow-up psychological assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSR interventionIn our study, it is the same to arm description. | Behavioural | mindfulness based stress reduction (MBSR) intervention |
Primary outcome
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
Time frame: 12 weeks
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.
The Posttraumatic Growth Inventory (PTG)
Time frame: 12 weeks
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.
Satisfaction with Life Scale (SWLS)
Time frame: 12 weeks
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.
Mindful Attention Awareness Scale (MAAS)
Time frame: 12 weeks
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.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 12 weeks
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.
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 12 weeks
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.
Patient Health Questionnaire (PHQ-9)
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng LI, professor study director
Department of Military Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR intervention in people with Posttraumatic Stress Symptom, run by Army Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.