NCT05283187

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

December 13, 2021

Last Update Submit

September 8, 2023

Conditions

Outcome Measures

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)

    Baseline and 8 week and 12 week

Study Arms (2)

MBCT

EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy Group

Control Group

NO INTERVENTION

No intervention

Interventions

Mindfulness Based Cognitive Therapy

MBCT

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a student of Düzce University, Faculty of Health Sciences, Department of Nursing
  • Individuals who voluntarily agree to participate in the research

You may not qualify if:

  • Those in acute depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferhan Açıkgöz

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31140627BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Aysel Karaca

    Duzce University

    STUDY DIRECTOR
  • Ferhan Açıkgöz

    Duzce University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 13, 2021

First Posted

March 16, 2022

Study Start

December 11, 2021

Primary Completion

January 17, 2023

Study Completion

January 18, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations