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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Ayşegül Yay Pençe

    Ankara, 06560

Other trials in Turkey (Türkiye)

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*

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 groups in NCT06156852
Study groupRoleWhat they receive
Mindfulness-based stress reduction group (MBSR)Active comparatorMedical 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 comparatorMedical 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.

  1. 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

  2. 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

  3. 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.

  1. First posted5 Dec 2023
  2. Study start1 Apr 2022
  3. Primary completion30 Dec 2022
  4. Study completion15 Jun 2023

Resources

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)
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

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.

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