StressNCT06156852
Comparing the Effects of Mindfulness-Based and Cognitive Behavioral-Based Stress Reduction in Medical Students
A study testing Mindfulness-based stress reduction group and Cognitive behavioral-based stress reduction group in people with Stress and Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and perceived stress of medical students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depressive Symptoms
- What is being tested?
- Mindfulness-based stress reduction group and Cognitive behavioral-based stress reduction group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 15 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
- Being a medical student at a university in Ankara
- Being older than 18 years old
- Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
- Volunteering to participate in the study
Who cannot join
- Having known mindfulness-based stress reduction methods and applied them in their lives
- Having known cognitive behavioral stress reduction methods and applied them in their lives
- Depression and mania severe enough to prevent their participation in the study
- High risk of suicide
- Having a chronic physical condition that may prevent participation in the study
- History of psychotic disorder and/or meeting the diagnosis of psychotic disorder at the assessment stage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing the Effects of Mindfulness-Based Stress Reduction and Cognitive Behavioral Therapy-Based Stress Reduction in Medical Students
We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and perceived stress of medical students.
323 medical students applied to participate in one of the group interventions and were assessed with the Mini International Neuropsychiatric Interview. Of these, 253 (77% female, mean age=21.9 ± 2.9 years) were allocated into online MBSR (n=127) and online CBSR (n=126) groups after randomization. Their anxiety and depressive symptoms and perceived stress levels were assessed at baseline and after 8 weeks of interventions.
Read the detailed description
Objective: Medical students face an enormous amount of stress. They suffer from higher rates of depression, anxiety, and suicide compared to the general population. Despite experiencing more mental health problems, there is a lack of research exploring ways to improve their mental health. Although there are a few small sample studies investigating the effectiveness of Mindfulness-Based Stress Reduction (MBSR) on medical students, there is no study comparing its effectiveness against an active intervention group in the literature.
Aim: We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and the perceived stress level of medical students.
Methods: The medical students who studied in medical faculties in Ankara/Turkey were asked to participate in our study. In order to invite students to the study, posters announcing our study were put on the boards of the lecture halls of medical faculties, and our posters were shared on social media platforms where these students were involved. After receiving applications from a sufficient number of students who volunteered to participate in the study, the students were assessed online with Mini International Neuropsychiatric Interview by a senior psychiatry resident. Medical students who were eligible to take part in the study were asked to fill out the forms (sociodemographic data form) and scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week before being allocated into groups. After the students were randomized into two groups with the help of a computer program, stress reduction interventions were conducted for 8 weeks in groups of 10-12 students. After enough participants volunteered to participate in the study, the participants were recruited mainly in two groups and randomized as they were recruited. The first group consisted of 157 participants and the second group consisted of 96 participants. When the group interventions were completed at the end of 8 weeks, the participants were asked to complete the scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week.
Inclusion Criteria:
- Being a medical student at a university in Ankara
- Being older than 18 years old
- Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
- Volunteering to participate in the study
Exclusion Criteria:
- Having known mindfulness-based stress reduction methods and applied them in their lives
- Having known cognitive behavioral stress reduction methods and applied them in their lives
- Depression and mania severe enough to prevent their participation in the study
- High risk of suicide
- Having a chronic physical condition that may prevent participation in the study
- History of psychotic disorder and/or meeting the diagnosis of psychotic disorder at the assessment stage
Cognitive Behavioral-Based Stress Reduction Groups Stress-coping groups based on cognitive behavioral methods were implemented by adapting them to medical faculty students. The whole intervention was done using the "Zoom" application on the online platform for 8 weeks. Each group meeting was 90 minutes long and held on a specific day and time of the week (19.00-20.30) previously determined by the group members. The groups were planned to consist of 10-12 people and no new members were included after the group started in order not to compromise the integrity of the group.
Mindfulness-Based Stress Reduction Groups Mindfulness-based stress reduction groups consist of structured 8-week 2-hour long group meetings and a 4-hour silence day. Along with mindfulness practices, stress, stress management and use of mindfulness-based practices in daily life and interpersonal communication are the subjects that are being worked on during the sessions. Each group meeting was 120 minutes long and held on a specific day and time of the week (20.00-22.00) previously determined by the group members. The groups were planned to consist of 10-12 people and no new members were included after the group started in order not to compromise the integrity of the group.
Statistical Methods:
SPSS 29 was used for all statistical analysis. In our study, both intention-to-treat (ITT) analysis and per-protocol (PP) analysis were used to assess outcomes. In the ITT analysis, we used multiple imputation to address missing values. All assessments and group interventions were done online. In PP analysis, those who attended five or more sessions were considered to have completed the study. By using two methods and comparing the results of these analyses with each other, we aimed to obtain the most realistic results.
Assessment features-->Statistical methods
Determination of the sample size-->Power analysis(G*power)
Determining the suitability of the data for normal distribution-->Kolmogorov Smirnov / Shapiro-Wilks test Skewness and kurtosis (-1.5- +1.5) Q-Q plot (linearity analysis)
Analyzing the demographic data of the participants-->Percentage distribution, Frequency distribution
Comparison of demographic data of the participants in the two groups-->Chi-square, Independent sample t-test
Comparison of the pre-test and post-test results of the participants in the two groups for each group-->Dependent sample t-test, Mann Whitney U test
Comparison of the change between pre-test and post-test between two groups -->Independent sample t-test, Wilcoxon signed-rank test
Investigate patterns of missingness and assignment of missing data-->Little's test Multiple imputation*
- Conditions
- Stress, Anxiety, Depressive Symptoms
- Being tested
- Mindfulness-based stress reduction group, Cognitive behavioral-based stress reduction group
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction groupOther
Mindfulness-based stress reduction (MBSR) group interventions were implemented for eight weeks.
Cognitive behavioral-based stress reduction groupOther
Cognitive behavioral-based stress reduction group interventions were implemented for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction group (MBSR) | Active comparator | Medical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups). Receives: Other: Mindfulness-based stress reduction group |
| Cognitive behavioral based stress reduction group (CBSR) | Active comparator | Medical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups). Receives: Other: Cognitive behavioral-based stress reduction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress level
Perceived stress levels were assessed with the Perceived Stress Scale (PSS). This is a widely used scale to assess the effects of different situations on our emotions and perceived stress.
Measured: 8 weeks
Anxiety level
Anxiety symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.
Measured: 8 weeks
Depressive symptom level
Depressive symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Apr 2022
- Primary completion30 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Yay, Gazi University
- Investigators
- Selçuk Aslan, MD, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156852
- Sponsor's protocol ID
- GaziU_0001
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing the Effects of Mindfulness-Based Stress Reduction and Cognitive Behavioral Therapy-Based Stress Reduction in Medical Students
- ClinicalTrials.gov ID
- NCT06156852
- Acronym / sponsor ID
- GaziU_0001
- Conditions
- Stress, Anxiety, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 5 Dec 2023 (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.
We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and perceived stress of medical students.
323 medical students applied to participate in one of the group interventions and were assessed with the Mini International Neuropsychiatric Interview. Of these, 253 (77% female, mean age=21.9 ± 2.9 years) were allocated into online MBSR (n=127) and online CBSR (n=126) groups after randomization. Their anxiety and depressive symptoms and perceived stress levels were assessed at baseline and after 8 weeks of interventions.
Detailed description
Objective: Medical students face an enormous amount of stress. They suffer from higher rates of depression, anxiety, and suicide compared to the general population. Despite experiencing more mental health problems, there is a lack of research exploring ways to improve their mental health. Although there are a few small sample studies investigating the effectiveness of Mindfulness-Based Stress Reduction (MBSR) on medical students, there is no study comparing its effectiveness against an active intervention group in the literature.
Aim: We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and the perceived stress level of medical students.
Methods: The medical students who studied in medical faculties in Ankara/Turkey were asked to participate in our study. In order to invite students to the study, posters announcing our study were put on the boards of the lecture halls of medical faculties, and our posters were shared on social media platforms where these students were involved. After receiving applications from a sufficient number of students who volunteered to participate in the study, the students were assessed online with Mini International Neuropsychiatric Interview by a senior psychiatry resident. Medical students who were eligible to take part in the study were asked to fill out the forms (sociodemographic data form) and scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week before being allocated into groups. After the students were randomized into two groups with the help of a computer program, stress reduction interventions were conducted for 8 weeks in groups of 10-12 students. After enough participants volunteered to participate in the study, the participants were recruited mainly in two groups and randomized as they were recruited. The first group consisted of 157 participants and the second group consisted of 96 participants. When the group interventions were completed at the end of 8 weeks, the participants were asked to complete the scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week.
Inclusion Criteria:
- Being a medical student at a university in Ankara
- Being older than 18 years old
- Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
- Volunteering to participate in the study
Exclusion Criteria:
- Having known mindfulness-based stress reduction methods and applied them in their lives
- Having known cognitive behavioral stress reduction methods and applied them in their lives
- Depression and mania severe enough to prevent their participation in the study
- High risk of suicide
- Having a chronic physical condition that may prevent participation in the study
- History of psychotic disorder and/or meeting the diagnosis of psychotic disorder at the assessment stage
Cognitive Behavioral-Based Stress Reduction Groups Stress-coping groups based on cognitive behavioral methods were implemented by adapting them to medical faculty students. The whole intervention was done using the "Zoom" application on the online platform for 8 weeks. Each group meeting was 90 minutes long and held on a specific day and time of the week (19.00-20.30) previously determined by the group members. The groups were planned to consist of 10-12 people and no new members were included after the group started in order not to compromise the integrity of the group.
Mindfulness-Based Stress Reduction Groups Mindfulness-based stress reduction groups consist of structured 8-week 2-hour long group meetings and a 4-hour silence day. Along with mindfulness practices, stress, stress management and use of mindfulness-based practices in daily life and interpersonal communication are the subjects that are being worked on during the sessions. Each group meeting was 120 minutes long and held on a specific day and time of the week (20.00-22.00) previously determined by the group members. The groups were planned to consist of 10-12 people and no new members were included after the group started in order not to compromise the integrity of the group.
Statistical Methods:
SPSS 29 was used for all statistical analysis. In our study, both intention-to-treat (ITT) analysis and per-protocol (PP) analysis were used to assess outcomes. In the ITT analysis, we used multiple imputation to address missing values. All assessments and group interventions were done online. In PP analysis, those who attended five or more sessions were considered to have completed the study. By using two methods and comparing the results of these analyses with each other, we aimed to obtain the most realistic results.
Assessment features-->Statistical methods
Determination of the sample size-->Power analysis(G*power)
Determining the suitability of the data for normal distribution-->Kolmogorov Smirnov / Shapiro-Wilks test Skewness and kurtosis (-1.5- +1.5) Q-Q plot (linearity analysis)
Analyzing the demographic data of the participants-->Percentage distribution, Frequency distribution
Comparison of demographic data of the participants in the two groups-->Chi-square, Independent sample t-test
Comparison of the pre-test and post-test results of the participants in the two groups for each group-->Dependent sample t-test, Mann Whitney U test
Comparison of the change between pre-test and post-test between two groups -->Independent sample t-test, Wilcoxon signed-rank test
Investigate patterns of missingness and assignment of missing data-->Little's test Multiple imputation*
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction group (MBSR) | Active comparator | Other: Mindfulness-based stress reduction groupMedical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups). |
| Cognitive behavioral based stress reduction group (CBSR) | Active comparator | Other: Cognitive behavioral-based stress reduction groupMedical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a medical student at a university in Ankara
- Being older than 18 years old
- Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Having known mindfulness-based stress reduction methods and applied them in their lives
- Having known cognitive behavioral stress reduction methods and applied them in their lives
- Depression and mania severe enough to prevent their participation in the study
- High risk of suicide
- Having a chronic physical condition that may prevent participation in the study
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 |
|---|---|---|
| Mindfulness-based stress reduction groupMindfulness-based stress reduction (MBSR) group interventions were implemented for eight weeks. | Other | Mindfulness-based stress reduction group (MBSR) |
| Cognitive behavioral-based stress reduction groupCognitive behavioral-based stress reduction group interventions were implemented for eight weeks. | Other | Cognitive behavioral based stress reduction group (CBSR) |
Primary outcome
Perceived stress level
Time frame: 8 weeks
Perceived stress levels were assessed with the Perceived Stress Scale (PSS). This is a widely used scale to assess the effects of different situations on our emotions and perceived stress.
Anxiety level
Time frame: 8 weeks
Anxiety symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.
Depressive symptom level
Time frame: 8 weeks
Depressive symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.
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 5 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Selçuk Aslan, MD study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction group and Cognitive behavioral-based stress reduction group in people with Stress and Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 5 Dec 2023. 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 Turkey (Türkiye). 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?
Perceived stress level (time frame: 8 weeks). The study lists 3 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 5 Dec 2023.