- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283187
The Effect of Mindfulness-Based Cognitive Therapy Program Applied to Nursing Students
September 8, 2023 updated by: Ferhan Acikgoz, Duzce University
The Effect of Mindfulness-Based Cognitive Therapy Program (MBCT) Applied to Nursing Students on Depression, Anxiety, Stress and Cognitive Flexibility: A Randomized Controlled Study
Among the stress factors of nursing students are traumatic experiences such as death and encountering a dying patient from the first moments of their education years, fear of making mistakes in the clinic, patient care, not getting enough support from the instructor or clinic staff, and communication problems.
Exposure to long-term and uncontrollable stress negatively affects students' professional identity development and health.
Students who cannot cope with their stress feel stress at a higher level and as a result they may experience anxiety and depression.It is important for nurse candidates to graduate by being supported in all aspects, both in terms of individual and professional development.
For this reason, nursing educators should use effective and innovative interventions to help students recognize the stress they experience and help them reduce stress.
Mindfulness-Based Cognitive Therapy Program (MBCT) is one of these programs.
Although studies with MBCT are found in the literature, our country In the literature, no randomized controlled studies were found with nursing students.
In line with this information, it was thought that mindfulness-based studies were needed.
This study was planned to determine the effect of MBCT program on depression, anxiety, stress and cognitive flexibility of nursing students.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Inclusion criteria for research
- to be nursing students
- to have a score of 4 or more (General Health Questionnaire)
- Internet access to participate in online sessions
- Individuals who voluntarily agree to participate in the research will be included.
Exclusion criteria from the research
- Those who are in the acute depression period
- Risk of suicidal
- Having participated in MBSR-MBCT programs before
Application Protocol Principles
- to consider students individuality, to provide correct information/education,
- Guiding to increase motivation,
- Giving feedback and supporting individuals,
- to provide accessibility for individuals' concerns and questions,
Study Type
Interventional
Enrollment (Actual)
87
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
-
-
-
Duzce, Turkey, 81620
- Ferhan Açıkgöz
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a student of Düzce University, Faculty of Health Sciences, Department of Nursing
- Individuals who voluntarily agree to participate in the research
Exclusion Criteria:
- Those in acute depression
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 |
---|---|
No Intervention: Control Group
No intervention
|
|
Experimental: MBCT
Mindfulness Based Cognitive Therapy
|
Mindfulness Based Cognitive Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in the Depression at 3 Months
Time Frame: Baseline and 8 week and 12 week
|
Depression Stress and Anxiety Scala-42 (depression score; first to nine normal, 10-13 mild, 14-20 is intermediate, 21-27 is advanced, over 28 is very advanced)
|
Baseline and 8 week and 12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aysel Karaca, Duzce University
- Principal Investigator: Ferhan Açıkgöz, Duzce University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 11, 2021
Primary Completion (Actual)
January 17, 2023
Study Completion (Actual)
January 18, 2023
Study Registration Dates
First Submitted
December 13, 2021
First Submitted That Met QC Criteria
March 7, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DuzceUFAcikgoz1
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 Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Taichung Veterans General HospitalUnknown
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
Clinical Trials on Mindfulness Based Cognitive Therapy Group
-
University Medical Center GroningenUniversity of GroningenCompleted
-
Bar-Ilan University, IsraelMaccabi Healthcare Services, IsraelCompletedDepression | PTSD | Stress | Fibromyalgia | Sleep DisturbanceIsrael
-
University of Southern DenmarkCenter for Kognitive Terapier og SupervisionUnknown
-
Hopital MontfortUniversity of Ottawa; Ontario Mental Health FoundationCompletedSocial Anxiety DisorderCanada
-
National Taiwan University HospitalUnknownStress, Psychological | Unipolar Depression | Psychophysiologic DisordersTaiwan
-
University of WarsawNot yet recruitingModerate Depressive Episode | Mild Depressive Episode
-
Oregon Health and Science UniversityTerminatedPostpartum Depression | Prenatal Stress | Maternal Psychological DistressUnited States
-
Ohio UniversityUnknownStress, Psychological | Stress, Physiological
-
The University of QueenslandUniversity of Alabama at Birmingham; Rush University Medical Center; University...Completed
-
Oregon Health and Science UniversityCompletedPregnancy Related | Infant Development | Prenatal Stress | Functional Neuroimaging | Maternal Psychological DistressUnited States