- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987905
The Effect of MIND-BE Program on Mental Health Parameters (Mindfulness Based Empowerment) (MIND-BE)
June 2, 2022 updated by: Hilal Altundal
The Effect of MIND-BE Program Applied to Intensive Care Nurses on Mental Health Parameters (Mindfulness Based Empowerment)
This study will be carried out in a pre-test-post-test, randomized controlled (parallel), experimental order in order to examine the effect of the MIND-BE program applied to intensive care nurses on mental health parameters.
The hypothesis of this study is that MIND-BE program increases resilience, posttraumatic growth, mindfulness, self-compassion levels, and reduces mental symptoms.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In the study, the MIND-BE program will be applied to the nurses (n=49) in the intervention group.
Considering the studies on mindfulness on nurses, it is planned to practice mindfulness for 60 minutes once a week for 8 weeks.
Mindfulness practice will be done online using appropriate platforms on the days and hours determined by Hilal Altundal (H.A.), who has a Mindfulness Institute-approved document.
In the control group (n=49), no intervention will be made for 8 weeks.
Results will be collected through data collection forms before the MIND-BE program, after the MIND-BE program is completed (8th week), and one month after the MIND-BE program is completed (12th week).
The data collection forms applied to all nurses in the intervention and control groups at the beginning of the study will be applied again at the end of the 8th and 12th weeks.
The primary expected outcome of the study is the effect of the MIND-BE program on nurses' resilience, posttraumatic growth, mindfulness, and self-compassion.
The secondary expected result of the study is to determine the effect of the MIND-BE program on the mental health of nurses.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mersin, Turkey, 33343
- Mersin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 18-65
- Written consent was obtained before participating in the study.
- Working as a nurse in the relevant institution on the dates of the study
- Not receiving any other psychological therapy during their working dates
- No prior meditation experience
- No practice in daily mind-body practices
- The participants (nurses) do not have any physical/mental disability or limitation and disease that would prevent them from participating in the program (no psychiatric diagnosis, no psychiatric medication, previous ear, brain, spinal cord surgery, acute retinal hemorrhage, vertebral fracture, and diaphragm rupture, hiatus or abdominal hernia, acute myocardial infarction, stable uncontrolled angina pectoris, severe coronary artery disease, congestive heart failure, severe valvular heart disease, acute myocarditis, acute and unstable musculoskeletal injuries, uncontrollable systemic hypertension, severe dementia and behavioral disorders) individuals are included in the study. will be included.
Exclusion Criteria:
- The participants (nurses) who could not complete eight sessions for different reasons and had to leave halfway through (illness, moving, changing service, etc.)
- The participants who participated in more than 70% of a mindfulness-based intervention prior to the study
- It is determined/specified that there are other existing health problems (physical/mental) after starting the education.
- Participating in less than 70% of the eight-week program
- Doing less than 70% of formal and informal practices
- Who left the program voluntarily
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
In the study, for 60 minutes once a week for 8 weeks the MIND-BE program will be applied to nurses.
The program includes formal and informal practices of mindfulness ("Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice).
In addition to these, nurses will be required to keep a diary of the program.
This app contains basic mindfulness exercises and does not pose any health risks to practitioners.
While the MIND-BE program is carried out in the online environment, the cameras of the nurses in the experimental group will be turned on and the researcher who made the application will be able to see each nurse.
|
In the study, for 60 minutes once a week for 8 weeks MIND-BE program will be applied to nurses.
The program includes formal and informal practices of mindfulness ("Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice).
|
|
No Intervention: Control Group
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
After all data are collected (after the 12th week), the training content will be explained to the nurses in the control group and the MIND-BE program will be started for them as well.
In this way, both groups will benefit from this program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience will evaluate using The Resilience Scale for Adults
Time Frame: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
It was developed by Friborg et al.
The Turkish validity and reliability of the scale was done by Basım and Çetin.
The 33-item scale consists of six sub-dimensions: "Self Perception", "Future Perception", "Structural Style", "Social Competence", "Family Cohesion" and "Social Resources".
Opposite each item in the scale, there are five boxes with changing expressions for each question and showing a five-point Likert structure.
Questions 1,3,4,8,11,12,13,14,15,16,23,24,25,27,31,33 in the scale without any cutoff point are reverse coded.
The scoring of the boxes ranges from 1 to 5 for flat coded items; from 5 to 1 for reverse coded items.
The total Cronbach's alpha coefficient of the scale is 0.86, and the Cronbach's alpha coefficients of the sub-dimensions range from 0.66 to 0.81.
|
Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
|
Posttraumatic growth will evaluate using The Post Traumatic Growth Inventory
Time Frame: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
It was developed by Tedeschi and Calhoun (1996).
The Turkish validity and reliability of the scale was done by Kağan et al. (2012).
Consisting of 21 items in total, the scale has a six-grade Likert structure (No way (0), Very little (1), A little (2), Moderate (3), Quite a lot (4), Very much (5)) .
The scale consists of three sub-dimensions: "self-perception", "change in philosophy of life" and "relationship with others".
An increase in the scores obtained from the scale without any cut-off point indicates that the level of post-traumatic growth increases.
Similarly, the increase in the scores obtained from the sub-dimensions indicates that the sub-dimensions with increasing scores are used more.
The Cronbach's alpha values of the scale ranged from 0.92, and the Cronbach's alpha values of the sub-dimensions ranged from 0.77 to 0.88.
|
Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
|
Mindfulness will evaluate using The Mindful Attention Awareness Scale
Time Frame: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
The Mindful Attention Awareness Scale (MAAS), developed by Brown and Ryan (2003), is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life.
MAAS has a single factor structure and gives a single total score.
High scores on the scale indicate high conscious awareness.
The MAAS is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The internal consistency coefficient was determined as 0.80 in the Turkish adaptation study of the MAAS by Özçiçek et al. (2011).
|
Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
|
Self-compassion will evaluate using The self-compassion scale
Time Frame: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
Developed by Neff (2003), Akın et al. (2007), the self-compassion scale (self-compassion scale) consists of 26 items and six subscales (self-compassion, self-judgment, shared human experience, isolation, mindfulness, and hyper-identification).
In this scale, which has a five-point Likert-type rating; almost never (1), rarely, sometimes, often, almost always (5).
In the study of Akın et al. (2007), the internal consistency of the subscales ranged between 0.72 and 0.80.
|
Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental symptom will evaluate using The Brief Symptom Inventory
Time Frame: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
The Brief Symptom Inventory (BSI) is based on the 90-item Symptom Check List (SCL-90) distributed over nine factors, and is a 53-item scale consisting of the items with the highest load in each factor.
The scale is a Likert-type self-evaluation inventory developed by Deregotis in 1992.
The scale is the short form of the Mental Symptom Checklist and consists of five subscales and three global indexes.
As a result of these studies, in the Turkish adaptation of the scale by Şahin and Durak (2002), the BSI was organized into five subsections as "Anxiety", "Depression", "Negative Self", "Somatization" and "Hostility".
An increase in the total score indicates an increase in the weight of the question.
There is no cut-off value for BSI.
The alpha coefficients found for the subscales of BSI in the study were Depression, α=0.88; anxiety, α=0.87; negative self, α=0.87; somatization, α=0.75; hostility is listed as α=0.76.
The points that can be obtained from the inventory range from 0 to 212.
|
Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mualla Yılmaz, Professor, Mersin University, Faculty of Nursing, Ciftlikkoy Campus, 33343, Yenisehir, Mersin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2021
Primary Completion (Actual)
September 24, 2021
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
July 28, 2021
First Submitted That Met QC Criteria
July 28, 2021
First Posted (Actual)
August 3, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Hilal Altundal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Mindfulness
-
University of Illinois at Urbana-ChampaignNorthwestern University Feinberg School of Medicine; Southern Illinois University and other collaboratorsNot yet recruitingPain, Postoperative | Depression, Unipolar
-
University of HoustonCompletedDepression | Stress | Anxiety | Well-beingUnited States
-
IsalaHelen Dowling InstituteNot yet recruitingCancer | Mindfulness Based Cognitive Therapy
-
University of UlsterRecruitingCervical Cancer | Gynecologic Cancer | Vulvar Cancer | Vaginal Cancer | Uterus Cancer | Ovary CancerUnited Kingdom
-
VA Boston Healthcare SystemRecruitingTBI (Traumatic Brain Injury) | Mild Cognitive Impairment (MCI) | Healthy Elderly | Aging | Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease | Alzheimer's Dementia (AD)United States
-
Chang Gung University of Science and TechnologyNational Science and Technology Council, TaiwanNot yet recruitingHealthy Aging | Mindfulness
-
Jordan University of Science and TechnologyCompleted
-
NURDİLAN SENERKırklareli UniversityCompletedPremenstrual SyndromeTurkey