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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05602012
Other study ID # FErcan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2022
Est. completion date March 22, 2023

Study information

Verified date March 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine the effect of group mindfulness based cognitive counseling on social anxiety, assertiveness and self-confidence in nursing students and the relationship of these variables to change over time.


Description:

This is a randomized controlled and single-center study. The universe of the research consisted of nursing students who applied for counseling within the scope of the announcement made on the department web page. The research will be carried out in a state university, Faculty of Health Sciences, Department of Nursing between February 22, 2022 - December 23, 2022. In the study, the assignment of students to the intervention and control groups was made by simple randomization. Participant Information Form, Liebowitz Social Anxiety Scale, Self-Confidence Scale and Assertiveness Inventory will be used to collect the data of the study. Data collection tools will be applied three times simultaneously with the control group as a pre-test at the beginning of the study, as a post-test at the last session of the intervention group ( 2 month), and as a follow-up test 6 months after the last session of the intervention group.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 22, 2023
Est. primary completion date June 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Liebowitz social anxiety scale score >50 - 18 years of age or older - Volunteering to participate in the study Exclusion Criteria: - Diagnosed with a mental disorders - History of participating in a counseling program - Currently receiving individual or group counseling - Unable to attend more than two sessions - Diagnosed with a physical or mental disorder during group sessions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness based cognitive counseling group
Intervention: The sessions were conducted by the researchers who received training in the field of Mindfulness Based Cognitive Therapy. Sessions are structured as follows; 'Awareness and autopilot, living in our minds, tidying up the dispersed mind, recognizing the unpleasant/version, allowing, ways to take care of oneself, turning to face difficulties, being stuck in the past, living in the present?'

Locations

Country Name City State
Turkey Feride Ercan Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Demir S, Ercan F. The effectiveness of cognitive behavioral therapy-based group counseling on depressive symptomatology, anxiety levels, automatic thoughts, and coping ways Turkish nursing students: A randomized controlled trial. Perspect Psychiatr Care. 2022 Oct;58(4):2394-2406. doi: 10.1111/ppc.13073. Epub 2022 Mar 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Liebowitz Social Anxiety Scale A 24-item self-report measure that assesses fear and avoidance of social performance and social situations. The total scale score ranges from a minimum of 48 to a maximum of 192. An increase in the score indicates that the level of social anxiety and avoidance behavior are intensified. Change from baseline to week 8 (2-month) and 6-month follow up
Secondary Assertiveness Inventory A 28-item self report inventory that assesses level of assertiveness. The total score that can be obtained from the scale is between a minimum of 28 and a maximum of 168. As the individual's score from the scale increases, the level of confidence increases. Change from baseline to week 8 (2-month) and 6-month follow-up
Secondary Self Confidence Scale A 33-item self report scale that assesses level of self confidence. The highest score that can be obtained from the scale is 165 and the lowest score is 33. A high score from the scale indicates a high level of self-confidence. Change from baseline to week 8 (2-month) and 6-month follow-up
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