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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Ankara, Turkey
        • Feride Ercan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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?'
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assertiveness Inventory
Time Frame: Change from baseline to week 8 (2-month) and 6-month follow-up
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
Self Confidence Scale
Time Frame: Change from baseline to week 8 (2-month) and 6-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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