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CompletedNCT05283187Updated Sep 13, 2023

The Effect of Mindfulness-Based Cognitive Therapy Program Applied to Nursing Students

An interventional study of Mindfulness Based Cognitive Therapy Group in Mindfulness, Depression, Anxiety and Stress, sponsored by Duzce University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Duzce University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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,
02

Conditions studied

  • Mindfulness
  • Depression, Anxiety
  • Stress
  • Nursing Students
03

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 87 is close to the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Duzce University is the lead sponsor of 75 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Those in acute depression
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    MBCT

    Mindfulness Based Cognitive Therapy

    Behavioral: Mindfulness Based Cognitive Therapy Group

  • No intervention
    Control Group

    No intervention

Interventions

  • BehavioralMindfulness Based Cognitive Therapy Group

    Mindfulness Based Cognitive Therapy

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline and 8 week and 12 week

07

Study locations

1 site
  • Ferhan Açıkgöz
    Düzce, 81620, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jan 2023, 13 months.

Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 13 months is below that.

Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2021
First posted
Mar 16, 2022
StartActual
Dec 11, 2021
Primary completionActual
Jan 17, 2023
CompletionActual
Jan 18, 2023
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05283187
Lead sponsor
Duzce University
Responsible party
Ferhan Acikgoz (Lecturer, Duzce University) — Principal investigator
First posted
Mar 16, 2022
Start date
Dec 11, 2021
Primary completion
Jan 17, 2023
Completion
Jan 18, 2023
Last update
Sep 13, 2023

Study contacts

Aysel Karaca
study director · Duzce University
Ferhan Açıkgöz
principal investigator · Duzce University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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