NCT05602012

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

October 25, 2022

Last Update Submit

March 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assertiveness Inventory

    Change from baseline to week 8 (2-month) and 6-month follow-up

  • Self Confidence Scale

    Change from baseline to week 8 (2-month) and 6-month follow-up

Study Arms (2)

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.

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.

Interventions

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?'

Mindfulness Based Cognitive Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liebowitz social anxiety scale score \>50
  • years of age or older
  • Volunteering to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feride Ercan

Ankara, Turkey (Türkiye)

Location

Related 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.

    PMID: 35332542BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 1, 2022

Study Start

February 22, 2022

Primary Completion

June 17, 2022

Study Completion

March 22, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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.

Locations