MindfulnessNCT05283187
The Effect of Mindfulness-Based Cognitive Therapy Program Applied to Nursing Students
A study testing Mindfulness Based Cognitive Therapy Group in people with Mindfulness and Depression, Anxiety, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Depression, Anxiety, Stress
- What is being tested?
- Mindfulness Based Cognitive Therapy Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2021to 18 Jan 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a student of Düzce University, Faculty of Health Sciences, Department of Nursing
- Individuals who voluntarily agree to participate in the research
Who cannot join
- Those in acute depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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,
- Conditions
- Mindfulness, Depression, Anxiety, Stress, Nursing Students
- Being tested
- Mindfulness Based Cognitive Therapy Group
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy GroupBehavioural
Mindfulness Based Cognitive Therapy
| Study group | Role | What they receive |
|---|---|---|
| MBCT | Experimental | Mindfulness Based Cognitive Therapy Receives: Behavioral: Mindfulness Based Cognitive Therapy Group |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Depression at 3 Months
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)
Measured: Baseline and 8 week and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start11 Dec 2021
- Primary completion17 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferhan Acikgoz, Duzce University
- Investigators
- Aysel Karaca, Study director, Duzce UniversityFerhan Açıkgöz, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283187
- Sponsor's protocol ID
- DuzceUFAcikgoz1
- Status last verified
- Sep 2023
- First submitted
- 13 Dec 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuksel A, Bahadir-Yilmaz E. Relationship between depression, anxiety, cognitive distortions, and psychological well-being among nursing students. Perspect Psychiatr Care. 2019 Oct;55(4):690-696. doi: 10.1111/ppc.12404. Epub 2019 May 29.
PubMed 31140627
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Cognitive Therapy Program (MBCT) Applied to Nursing Students on Depression, Anxiety, Stress and Cognitive Flexibility: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05283187
- Acronym / sponsor ID
- DuzceUFAcikgoz1
- Conditions
- Mindfulness, Depression, Anxiety, Stress, Nursing Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 16 Mar 2022 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT | Experimental | Behavioral: Mindfulness Based Cognitive Therapy GroupMindfulness Based Cognitive Therapy |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being a student of Düzce University, Faculty of Health Sciences, Department of Nursing
- Individuals who voluntarily agree to participate in the research
Key exclusion criteria (1 listed)
- Those in acute depression
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 Cognitive Therapy GroupMindfulness Based Cognitive Therapy | Behavioural | MBCT |
Primary outcome
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)
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 13 Sep 2023.
- Background: PubMed 31140627Yuksel A, Bahadir-Yilmaz E. Relationship between depression, anxiety, cognitive distortions, and psychological well-being among nursing students. Perspect Psychiatr Care. 2019 Oct;55(4):690-696. doi: 10.1111/ppc.12404. Epub 2019 May 29.
- Individual participant dataSharing planned: No
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Caregiver
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.
Aysel Karaca study director
Duzce University
Ferhan Açıkgöz principal investigator
Duzce 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 Cognitive Therapy Group in people with Mindfulness and Depression, Anxiety, run by Duzce 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 2 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 13 Sep 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 from Baseline in the Depression at 3 Months (time frame: Baseline and 8 week and 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283187, which also lists 1 linked publication.
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 13 Sep 2023.