Social AnxietyNCT05602012
Mindfulness Based Cognitive Counseling on Social Anxiety
A study testing Mindfulness based cognitive counseling group in people with Social Anxiety and Assertiveness, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety, Assertiveness, Self Confidence
- What is being tested?
- Mindfulness based cognitive counseling group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2022to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Liebowitz social anxiety scale score >50
- 18 years of age or older
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety, Assertiveness, Self Confidence
- Being tested
- Mindfulness based cognitive counseling group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based cognitive counseling groupBehavioural
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?'
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Counseling | Experimental | 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. Receives: Behavioral: Mindfulness based cognitive counseling group |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to week 8 (2-month) and 6-month follow up
Secondary outcomes (2)
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.
Measured: Change from baseline to week 8 (2-month) and 6-month follow-up
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.
Measured: Change from baseline to week 8 (2-month) and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start22 Feb 2022
- Primary completion17 Jun 2022
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feride Ercan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602012
- Sponsor's protocol ID
- FErcan
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35332542
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Cognitive Counseling Group for Social Anxiety, Assertiveness and Self-Confidence in Nursing Students
- ClinicalTrials.gov ID
- NCT05602012
- Acronym / sponsor ID
- FErcan
- Conditions
- Social Anxiety, Assertiveness, Self Confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Counseling | Experimental | Behavioral: Mindfulness based cognitive counseling groupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liebowitz social anxiety scale score >50
- 18 years of age or older
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based cognitive counseling groupIntervention: 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?' | Behavioural | Mindfulness Based Cognitive Counseling |
Primary outcome
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.
2 secondary outcomes
Assertiveness Inventory
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 35332542Demir 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based cognitive counseling group in people with Social Anxiety and Assertiveness, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (time frame: Change from baseline to week 8 (2-month) and 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.