MindfulnessNCT05712499
Mindfulness-based Psychoeducation and Defense Mechanisms, Mindful Awareness
A study testing mindfulness-based psychoeducation program and ongoing life in people with Mindfulness and Psychoeducation, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Nowadays, it is seen that there is an increasing interest in mindfulness-based therapies. Such practices can be beneficial by contributing to the personal and professional development of nursing students. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Psychoeducation, Defense Mechanisms
- What is being tested?
- mindfulness-based psychoeducation program and ongoing life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 17 May 2021
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years old,
- Without a psychiatric diagnosis,
- Have not done awareness practices before,
- Not meditating,
- Not a foreign national,
- Those who volunteered to participate in the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Agri Ibrahim Cecen Universty /Faculty of Health Sciences
Ağrı, Central, 04100
About this study
Official title: Investigation of the Effect of Mindfulness-based Psychoeducation on Defense Mechanisms and Mindful Awareness in Nursing Students
Purpose: Nowadays, it is seen that there is an increasing interest in mindfulness-based therapies. Such practices can be beneficial by contributing to the personal and professional development of nursing students. In the study, the effect of mindfulness-based psychoeducation applied to Turkish nursing students on defense mechanisms and mindfulness was evaluated.
Method: The research was designed as a quasi-experimental study with a control group. The population of the study consisted of 96 newly enrolled students in the nursing department of a foundation university, and the sample consisted of a total of 72 students who met the inclusion criteria of the study. In the sample, while 33 students formed the intervention group, 39 students formed the control group. Mindfulness- Based Psychoeducation was given online in 16 sessions in 8 weeks. Data were collected using the Defense Style Questionnaire and the Awareness Scale.Percentage distributions were used in the analysis of the data, t-Test and Chi-Square test were used in the comparison of the intervention and control groups, and the paired-samples t-Test was used in the comparison of the intervention and control groups within the group.
Read the detailed description
Population-Sample It was conducted with 96 nursing students enrolled in the Faculty of Health Sciences of a state university in the east of Turkey in the 2020-2021 academic year. 86 students who met the research criteria (being a first-year student, being over the age of 18, not having any psychiatric diagnosis, volunteering to participate in the study, not having received mindfulness training before, not a foreign national) were included in the study. It was deemed appropriate to participate in the study by first-year students who were at the beginning of their nursing education and had not yet taken a course related to personal development (such as introduction to psychology, interpersonal relations and communication). Among these students, the intervention and control groups were formed after detailed information about the research process was given according to students' requests, without being randomized. Those who wanted to receive training and believed that they could attend the training continuously were determined as the intervention group (45), and those who did not want to participate in the training and were unsure were determined as the control group (41). However, the research was completed with 33 students in the intervention group and 39 students in the control group. 12 students from the intervention group left the research because they could not attend the sessions regularly, while 2 students in the control group left the research without stating a reason for their request. In the power analysis of 72 students participating in the research.
Data Collection and Program Application Due to the Covid-19 pandemic, nursing education was continued in our institution in the 2020-2021 academic year with a distance education called DEP(Distance Education Platform). This situation necessitated online psychoeducation to be given as part of the research. The Mindfulness-Based Psychoeducation program was conducted via DEP(Distance Education Platform)between 08.03.2021 and 30.04.2021 after obtaining the necessary permission and support from the institution. The scales created by the researcher through "Google Form" were shared with the students in the Mindfulness-Based Psychoeducation Program at DEP(Distance Education Platform)and the pretest data were collected in the first session, whereas the posttest data were collected two weeks after the last session. On the first page of this form, the purpose of the research was explained, the confirmation icon indicating that they voluntarily accepted to participate in the research, why they had to give name or code information, and the response time (30 minutes) for the forms were stated.
Data Collection Tools This study, Personal Information Form, Defense Style Questionnaire (DSQ-40), and Mindful Attention Awareness Scale (MAAS) were used.
Personal Information Form It consists of questions about the sociodemographic characteristics of the students (age, gender).
Defense Style Questionnaire (DSQ-40) In the scale, which determines the appearance of defense mechanisms at the level of consciousness and behavior, and consists of 40 items, 20 defenses, and 3 sub-dimensions (mature, neurotic, and immature), each item is evaluated between 1-9 (absolutely inappropriate - absolutely appropriate). Mature defenses are; suppression, anticipation, sublimation, and humor. Neurotic defenses; subversion, counter-reaction, idealization, and artificial altruism. Immature defenses are; passive aggression, expression, projection, isolation, denial, division, devaluation, autistic fantasy, displacement, dissociation, rationalization, and somatization. The scale is scored on defenses or sub-dimensions, not on the total score. Total score or arithmetic mean is used while calculating each defense or sub-dimension. As the score increases, the use of the defense/sub-dimension also increases. In the Turkish adaptation study of the scale, the Cronbach's Alpha values were 0.70, 0.61, and 0.83, respectively, according to the mature, neurotic, and immature sub-dimensions whereas in this study, it was 0.65, 0.71, and 0.82.
Mindful Attention Awareness Scale (MAAS) The scale has a 15-item and 6-point Likert feature that measures the differences in the ability to be aware of what is happening in the moment and to pay attention to them. The scores obtained from the scale vary between 15-90 points. A high score indicates a high level of mindful awareness. While the Cronbach Alpha value of the scale was 0.80 in the Turkish adaptation study, it was 0.82 in this study.
Mindfulness-based psychoeducation program Mindfulness-based cognitive therapies are evidence-based psychoeducation. Psychoeducation was organized in 2 consecutive sessions once a week for 8 weeks, and each session was 60 minutes, in total 16 sessions. The content of the psychoeducation program was explained in detail, and techniques such as presentation and question-answer narrative techniques, video, audio recording, mindfulness assignments for the next session were used in the training. A Whatsapp group was created to remind and share materials with students participating in psychoeducation. It was stated that the students should be very careful, observant, and patient while doing the practices to get to know themselves, be aware of their emotions, thoughts, bodily sensations and focus. The applications were performed online-live in DEP(Distance Education Platform)and recorded by the system. The researcher's camera was turned on and the students' camera was also left to preference. The privacy of all participants was given importance and it was stated that the existing recordings would not be used anywhere else, that the participants would not be able to take recordings, and that the sharing in the sessions should be kept confidential. The students were able to access the records at any time during the day that the psychoeducation started and for 15 days after the end of the psychoeducation. In the days when there is no psychoeducation, reminder messages were sent twice a week via and DEP(Distance Education Platform) applications for home applications.
Evaluation of Data The coding and analysis of the data were done via the SPSS-23( Statistical Package for the Social Sciences-23) program, and the significance level was accepted as p<0.05. Percentage distributions were used in the analysis of the data, t-Test and Chi-Square test were used in the comparison of the intervention and control groups, and the paired-samples t-Test was used in the comparison of the intervention and control groups within the group.
Declarations The necessary institutional permission and support for the research were obtained from the Deanery of the Faculty of Health Sciences. In addition, ethical permission was obtained from the Ethics Committee of the Institute of Health Sciences of the University. (Decision dated 27.01.2021 and numbered 2021/18). Oral and written informed consent was obtained from the students participating in the research and the research was conducted following the Principles of the Declaration of Helsinki.
- Conditions
- Mindfulness, Psychoeducation, Defense Mechanisms, Awareness
- Being tested
- mindfulness-based psychoeducation program, ongoing life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based psychoeducation programBehavioural
Mindful awareness is a mind and body practice that involves increasing attention to what is happening at the moment and accepting what is perceived without judgment. Mindfulness includes awareness and attention; Awareness is the mechanism that constantly controls the of the state of consciousness. Mindfulness-based cognitive therapies are evidence-based psychoeducation. Psychoeducation was organized in 2 consecutive sessions once a week for 8 weeks, and each session was 60 minutes, in total 16 sessions. The content of the psychoeducation program was explained in detail, and techniques such as presentation and question-answer narrative techniques, video, audio recording, mindfulness assignments for the next session were used in the training.
ongoing lifeBehavioural
The control group continued with their lives without any intervention. Only pre-test and post-test were applied. While the program was applied to the experimental group, no intervention was made to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based psychoeducation program | Experimental | The group in which the mindfulness-based psychoeducation program was applied. Receives: Behavioral: mindfulness-based psychoeducation program |
| control group | Active comparator | The group in which no intervention was made and only the pre-test and post-test were applied for comparison. Receives: Behavioral: ongoing life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of defense mechanisms level after 10 weeks.
Defense Style Questionnaire (DSQ-40) : In the scale, which determines the appearance of defense mechanisms at the level of consciousness and behavior, and consists of 40 items, 20 defenses, and 3 sub-dimensions (mature, neurotic, and immature), each item is evaluated between 1-9 (absolutely inappropriate - absolutely appropriate)The scale is scored on defenses or sub-dimensions, not on the total score. Total score or arithmetic mean is used while calculating each defense or sub-dimension. As the score increases, the use of the defense/sub-dimension also increases.
Measured: baseline and 10 weeks.
Change of mindful awareness level after 4 weeks.
Mindful Attention Awareness Scale (MAAS):The scale has a 15-item and 6-point Likert feature that measures the differences in the ability to be aware of what is happening in the moment and to pay attention to them. The scores obtained from the scale vary between 15-90 points. A high score indicates a high level of mindful awareness.
Measured: baseline and 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start8 Mar 2021
- Primary completion8 Mar 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a quasi-experimental study with a control group.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Demir Gokmen, Agri Ibrahim Cecen University
- Investigators
- Burcu Demir Gokmen, phd, Principal investigator, Agri Ibrahim Cecen Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712499
- Sponsor's protocol ID
- AICU-SBF-HB-BDG-01
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a plant for the use of other customers in the individual loading body (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Mindfulness-based Psychoeducation on Defense Mechanisms and Mindful Awareness in Nursing Students
- ClinicalTrials.gov ID
- NCT05712499
- Acronym / sponsor ID
- AICU-SBF-HB-BDG-01
- Conditions
- Mindfulness, Psychoeducation, Defense Mechanisms, Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 3 Feb 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.
Purpose: Nowadays, it is seen that there is an increasing interest in mindfulness-based therapies. Such practices can be beneficial by contributing to the personal and professional development of nursing students. In the study, the effect of mindfulness-based psychoeducation applied to Turkish nursing students on defense mechanisms and mindfulness was evaluated.
Method: The research was designed as a quasi-experimental study with a control group. The population of the study consisted of 96 newly enrolled students in the nursing department of a foundation university, and the sample consisted of a total of 72 students who met the inclusion criteria of the study. In the sample, while 33 students formed the intervention group, 39 students formed the control group. Mindfulness- Based Psychoeducation was given online in 16 sessions in 8 weeks. Data were collected using the Defense Style Questionnaire and the Awareness Scale.Percentage distributions were used in the analysis of the data, t-Test and Chi-Square test were used in the comparison of the intervention and control groups, and the paired-samples t-Test was used in the comparison of the intervention and control groups within the group.
Detailed description
Population-Sample It was conducted with 96 nursing students enrolled in the Faculty of Health Sciences of a state university in the east of Turkey in the 2020-2021 academic year. 86 students who met the research criteria (being a first-year student, being over the age of 18, not having any psychiatric diagnosis, volunteering to participate in the study, not having received mindfulness training before, not a foreign national) were included in the study. It was deemed appropriate to participate in the study by first-year students who were at the beginning of their nursing education and had not yet taken a course related to personal development (such as introduction to psychology, interpersonal relations and communication). Among these students, the intervention and control groups were formed after detailed information about the research process was given according to students' requests, without being randomized. Those who wanted to receive training and believed that they could attend the training continuously were determined as the intervention group (45), and those who did not want to participate in the training and were unsure were determined as the control group (41). However, the research was completed with 33 students in the intervention group and 39 students in the control group. 12 students from the intervention group left the research because they could not attend the sessions regularly, while 2 students in the control group left the research without stating a reason for their request. In the power analysis of 72 students participating in the research.
Data Collection and Program Application Due to the Covid-19 pandemic, nursing education was continued in our institution in the 2020-2021 academic year with a distance education called DEP(Distance Education Platform). This situation necessitated online psychoeducation to be given as part of the research. The Mindfulness-Based Psychoeducation program was conducted via DEP(Distance Education Platform)between 08.03.2021 and 30.04.2021 after obtaining the necessary permission and support from the institution. The scales created by the researcher through "Google Form" were shared with the students in the Mindfulness-Based Psychoeducation Program at DEP(Distance Education Platform)and the pretest data were collected in the first session, whereas the posttest data were collected two weeks after the last session. On the first page of this form, the purpose of the research was explained, the confirmation icon indicating that they voluntarily accepted to participate in the research, why they had to give name or code information, and the response time (30 minutes) for the forms were stated.
Data Collection Tools This study, Personal Information Form, Defense Style Questionnaire (DSQ-40), and Mindful Attention Awareness Scale (MAAS) were used.
Personal Information Form It consists of questions about the sociodemographic characteristics of the students (age, gender).
Defense Style Questionnaire (DSQ-40) In the scale, which determines the appearance of defense mechanisms at the level of consciousness and behavior, and consists of 40 items, 20 defenses, and 3 sub-dimensions (mature, neurotic, and immature), each item is evaluated between 1-9 (absolutely inappropriate - absolutely appropriate). Mature defenses are; suppression, anticipation, sublimation, and humor. Neurotic defenses; subversion, counter-reaction, idealization, and artificial altruism. Immature defenses are; passive aggression, expression, projection, isolation, denial, division, devaluation, autistic fantasy, displacement, dissociation, rationalization, and somatization. The scale is scored on defenses or sub-dimensions, not on the total score. Total score or arithmetic mean is used while calculating each defense or sub-dimension. As the score increases, the use of the defense/sub-dimension also increases. In the Turkish adaptation study of the scale, the Cronbach's Alpha values were 0.70, 0.61, and 0.83, respectively, according to the mature, neurotic, and immature sub-dimensions whereas in this study, it was 0.65, 0.71, and 0.82.
Mindful Attention Awareness Scale (MAAS) The scale has a 15-item and 6-point Likert feature that measures the differences in the ability to be aware of what is happening in the moment and to pay attention to them. The scores obtained from the scale vary between 15-90 points. A high score indicates a high level of mindful awareness. While the Cronbach Alpha value of the scale was 0.80 in the Turkish adaptation study, it was 0.82 in this study.
Mindfulness-based psychoeducation program Mindfulness-based cognitive therapies are evidence-based psychoeducation. Psychoeducation was organized in 2 consecutive sessions once a week for 8 weeks, and each session was 60 minutes, in total 16 sessions. The content of the psychoeducation program was explained in detail, and techniques such as presentation and question-answer narrative techniques, video, audio recording, mindfulness assignments for the next session were used in the training. A Whatsapp group was created to remind and share materials with students participating in psychoeducation. It was stated that the students should be very careful, observant, and patient while doing the practices to get to know themselves, be aware of their emotions, thoughts, bodily sensations and focus. The applications were performed online-live in DEP(Distance Education Platform)and recorded by the system. The researcher's camera was turned on and the students' camera was also left to preference. The privacy of all participants was given importance and it was stated that the existing recordings would not be used anywhere else, that the participants would not be able to take recordings, and that the sharing in the sessions should be kept confidential. The students were able to access the records at any time during the day that the psychoeducation started and for 15 days after the end of the psychoeducation. In the days when there is no psychoeducation, reminder messages were sent twice a week via and DEP(Distance Education Platform) applications for home applications.
Evaluation of Data The coding and analysis of the data were done via the SPSS-23( Statistical Package for the Social Sciences-23) program, and the significance level was accepted as p<0.05. Percentage distributions were used in the analysis of the data, t-Test and Chi-Square test were used in the comparison of the intervention and control groups, and the paired-samples t-Test was used in the comparison of the intervention and control groups within the group.
Declarations The necessary institutional permission and support for the research were obtained from the Deanery of the Faculty of Health Sciences. In addition, ethical permission was obtained from the Ethics Committee of the Institute of Health Sciences of the University. (Decision dated 27.01.2021 and numbered 2021/18). Oral and written informed consent was obtained from the students participating in the research and the research was conducted following the Principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a quasi-experimental study with a control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based psychoeducation program | Experimental | Behavioral: mindfulness-based psychoeducation programThe group in which the mindfulness-based psychoeducation program was applied. |
| control group | Active comparator | Behavioral: ongoing lifeThe group in which no intervention was made and only the pre-test and post-test were applied for comparison. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Over 18 years old,
- Without a psychiatric diagnosis,
Key exclusion criteria (1 listed)
- -
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 psychoeducation programMindful awareness is a mind and body practice that involves increasing attention to what is happening at the moment and accepting what is perceived without judgment. Mindfulness includes awareness and attention; Awareness is the mechanism that constantly controls the of the state of consciousness. Mindfulness-based cognitive therapies are evidence-based psychoeducation. Psychoeducation was organized in 2 consecutive sessions once a week for 8 weeks, and each session was 60 minutes, in total 16 sessions. The content of the psychoeducation program was explained in detail, and techniques such as presentation and question-answer narrative techniques, video, audio recording, mindfulness assignments for the next session were used in the training. | Behavioural | Mindfulness-based psychoeducation program |
| ongoing lifeThe control group continued with their lives without any intervention. Only pre-test and post-test were applied. While the program was applied to the experimental group, no intervention was made to the control group. | Behavioural | control group |
Primary outcome
Change of defense mechanisms level after 10 weeks.
Time frame: baseline and 10 weeks.
Defense Style Questionnaire (DSQ-40) : In the scale, which determines the appearance of defense mechanisms at the level of consciousness and behavior, and consists of 40 items, 20 defenses, and 3 sub-dimensions (mature, neurotic, and immature), each item is evaluated between 1-9 (absolutely inappropriate - absolutely appropriate)The scale is scored on defenses or sub-dimensions, not on the total score. Total score or arithmetic mean is used while calculating each defense or sub-dimension. As the score increases, the use of the defense/sub-dimension also increases.
Change of mindful awareness level after 4 weeks.
Time frame: baseline and 10 weeks.
Mindful Attention Awareness Scale (MAAS):The scale has a 15-item and 6-point Likert feature that measures the differences in the ability to be aware of what is happening in the moment and to pay attention to them. The scores obtained from the scale vary between 15-90 points. A high score indicates a high level of mindful awareness.
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 3 Feb 2023.
- Individual participant dataSharing planned: No. There is a plant for the use of other customers in the individual loading body (IPD).
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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.
Burcu Demir Gokmen, phd principal investigator
Agri Ibrahim Cecen Universty
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 psychoeducation program and ongoing life in people with Mindfulness and Psychoeducation, run by Agri Ibrahim Cecen 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 6 inclusion and 1 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 3 Feb 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?
Change of defense mechanisms level after 10 weeks. (time frame: baseline and 10 weeks.). The study lists 2 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 3 Feb 2023.