- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602012
Mindfulness Based Cognitive Counseling on Social Anxiety
March 24, 2023 updated by: Feride Ercan, Gazi University
The Effect of Mindfulness Based Cognitive Counseling Group for Social Anxiety, Assertiveness and Self-Confidence in Nursing Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Feride Ercan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mindfulness Based Cognitive Counseling
The intervention was conducted in two groups with 25 participants/12-13 for each groups and two researchers per group.
The program which consisted of eight sessions in total, was held once a week and each session lasted approximately 90-120 minutes.
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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?'
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No Intervention: No Intervention
Participants will not be given an intervention until after they have completed the study.
Data collection tools were applied to the students simultaneously with the intervention group, and after the follow-up test of the intervention group, a single-session information meeting will be held by the researchers for the students in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebowitz Social Anxiety Scale
Time Frame: Change from baseline to week 8 (2-month) and 6-month follow up
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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.
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Change from baseline to week 8 (2-month) and 6-month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assertiveness Inventory
Time Frame: Change from baseline to week 8 (2-month) and 6-month follow-up
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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.
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Change from baseline to week 8 (2-month) and 6-month follow-up
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Self Confidence Scale
Time Frame: Change from baseline to week 8 (2-month) and 6-month follow-up
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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.
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Change from baseline to week 8 (2-month) and 6-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2022
Primary Completion (Actual)
June 17, 2022
Study Completion (Actual)
March 22, 2023
Study Registration Dates
First Submitted
October 25, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 1, 2022
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FErcan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Other researchers will be able to reaad detailed information such as the research method and results when the research is published.
The "Research Protocol" will be available on the this PRS page.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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