NCT06464211

Brief Summary

This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. The research highlights the significance of university education in career development, noting the associated biopsychosocial challenges faced by students. These challenges often manifest as future anxiety-a condition characterized by fear, uncertainty, and stress about future prospects, which can impact students' academic performance, social relationships, and overall mental health. Literature reveals that interventions like CBT, mindfulness practices, and family counseling are effective in managing anxiety and enhancing emotional resilience. The program integrates these approaches to provide dual-layer support, addressing individual thought patterns and family dynamics, thus potentially reducing anxiety and increasing mindfulness among students. This study aims to provide a comprehensive understanding of the program's effectiveness in a controlled setting, contributing to both national and international literature on mental health interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable anxiety

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

May 7, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reduction in Future Anxiety Levels

    This measure assesses the change in future anxiety levels among university students participating in the Cognitive Behavioral Therapy-based Family Counseling Program. The Future Anxiety Scale for University Students will be used to quantify this change. The scale ranges from a minimum score of 19 to a maximum score of 95. Higher scores indicate an increase in the level of future anxiety.

    Baseline (at study start) and at 8 weeks post-intervention.

  • Improvement in Mindfulness Awareness Levels

    This outcome measures the enhancement in mindfulness awareness levels as determined by the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults. Changes from baseline to post-intervention will be assessed to determine the effectiveness of the intervention. The scale ranges from a minimum score of 18 to a maximum score of 90. Higher scores indicate an increase in the level of mindfulness awareness

    Baseline (at study start) and at 8 weeks post-intervention.

Study Arms (2)

experimental group

EXPERIMENTAL

There were 6 face-to-face sessions with students for 50- 60 minutes/week, and 2 sessions with internet-based video programs with students' families. Cognitive Behavioral Model-Based Family Counseling Program was conducted. At least one parent was asked to participate in the family sessions. After the implementation of the intervention group was completed, the final tests of the scales used in the research were applied again to both the intervention and the control group. After the data of the study were collected, a focus group interview, one of the interview methods used in qualitative research on the effectiveness and organization of a Cognitive Behavioral Model-Based Family Counseling Program, was conducted for 5 students selected from the initiative group and the effectiveness of the program was evaluated.

Behavioral: Cognitive Behavioral Model-Based Family Counseling Program

control group

NO INTERVENTION

no intervention

Interventions

A Cognitive Behavioral Model-Based Family Counseling Program is a therapeutic approach that focuses on identifying and changing negative thought patterns and behaviors within the family unit, using principles of cognitive-behavioral therapy to improve communication, resolve conflicts, and enhance overall family functioning.

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The level of future anxiety is above 40 points
  • No problems with speech, perception or hearing
  • The person or persons who will be included in the study from family members will be able to participate in the online session at the time required for counseling
  • The student will regularly participate in the interview sessions to be held

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IstanbulUC

Şişli, Istanbul, 34360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • merve geylani, MSc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was conducted using an experimental pre-test, post-test, follow-up randomized controlled group experimental research design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2024

First Posted

June 18, 2024

Study Start

January 2, 2022

Primary Completion

November 30, 2023

Study Completion

June 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations