The Effect of Mindfulness-Based Cognitive Therapy Program... | NCT05283187

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

NCT05283187

Sponsor

Duzce University

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Mindfulness
Depression, Anxiety
Stress
Nursing Students

Interventions

Mindfulness Based Cognitive Therapy Group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2021Actual

Primary Completion Date

Jan 17, 2023Actual

Completion Date

Jan 18, 2023Actual

First Submitted Date

Dec 13, 2021

First Submission Date that Met QC Criteria

Mar 7, 2022

First Posted Date

Mar 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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,

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MBCT	Experimental	Mindfulness Based Cognitive Therapy	Behavioral: Mindfulness Based Cognitive Therapy Group
Control Group	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Based Cognitive Therapy Group	Behavioral	Mindfulness Based Cognitive Therapy	MBCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aysel Karaca	Duzce University	Study Director
Ferhan Açıkgöz	Duzce University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ferhan Açıkgöz		Düzce		81620	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31140627	Background	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.

ID	Term
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders