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Clinical Trials/NCT07096154
NCT07096154RecruitingNot Applicable

Improving Emotional Wellbeing of University Students Using Culturally Adapted Cognitive Behavioural Approaches in Group Settings" (UniWELL-C): Protocol of a Feasibility and Effectiveness Study

Bogazici University2 sites in 1 country40 target enrollmentStarted: March 4, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Beck Anxiety Inventory (BAI)

Study Overview

Brief Summary

University students' psychological well-being is a growing public health concern. The university period is a key time for psychological, social, and academic development, which can increase vulnerability to mental health difficulties. Research suggests that group-based Cognitive Behavioural Therapy (CBT) is an effective, cost-efficient option for promoting student well-being. However, tailored interventions that reflect the cultural and contextual needs of specific populations are more likely to be effective. Western-based models of therapy may not always align with the cultural norms and experiences of students in countries like Türkiye.

In Türkiye, publicly accessible mental health services are limited, often reduced to short psychiatric consultations. Psychological therapies are primarily accessed privately, making free or low-cost university mental health services particularly valuable. Therefore, culturally adapted group CBT interventions may play a crucial role in supporting student mental health. This study, part of a larger project, aims to evaluate the effectiveness of CBT-based anxiety groups specifically tailored for Turkish university students.

Eligible participants are Bogazici University students aged 18 and over. Exclusion criteria include severe mental illness, high risk of harm to self or others, or scoring below the threshold on the Beck Anxiety Inventory. These individuals may require more specialized, individual support. The study includes participation in an 8-session CBT-based group focused on anxiety management. Participants may benefit from free psychological support, peer connection, and professional guidance. The study also contributes to the scientific literature by assessing the effectiveness of culturally adapted group interventions.

There are risks: participants may experience distress during sessions or while completing questionnaires. Support will be available from a master's student and/or the group therapist, under the supervision of a qualified clinical psychologist. If a participant's risk increases, they will be supported in accessing psychiatric care. An emergency contact will be required for safety. The study will run at Bogazici University in collaboration with BUREM and the Translational Clinical Psychology Lab, led by Dr. Ayse Akan (t-clinpsylab@bogazici.edu.tr). It is partially funded by Bogazici Scientific Research Projects (20022) and is expected to run for 1-3 years.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Must be a Bogazici University student.
  • •Must be 18 years or older.
  • •Must score above the threshold on the Beck Anxiety Inventory.

Exclusion Criteria

  • •Not Bogazici University student.
  • •Has serious and severe mental illness.
  • •High risk of self-harm/harm to others.
  • •Scoring below the threshold of the Beck Anxiety Inventory.
  • •Younger than 18 years old.

Arms & Interventions

CBT Experimental Arm

Experimental

An 8-session Group Cognitive Behavioural Therapy for anxiety management will be offered to the experimental group of about 40 university students who volunteered and scored above the threshold on the Beck Anxiety Inventory.

Intervention: Group CBT Anxiety Management (Behavioral)

CBT Waitlist Arm

No Intervention

CBT waitlist control

Outcomes

Primary Outcomes

Beck Anxiety Inventory (BAI)

Time Frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention

The Beck Anxiety Inventory (BAI) is a self-report questionnaire that measures the severity of anxiety levels. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severely - it bothered me a lot) resulting in a total score ranging from 0 to 63. Higher scores indicate greater levels of anxiety. The severity is categorized into "minimal", "mild", "moderate", and "severe".

Secondary Outcomes

  • Depression Anxiety and Stress Scale (DASS42)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Generalised Anxiety Disorder-7 (GAD7)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Patient Health Questionnaire (PHQ9)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Outcome Rating Scale (ORS)(From enrollment to the end of treatment at 8 weeks)
  • Qualitative data(Up to 12 weeks following the completion of the intervention)

Investigators

Sponsor
Bogazici University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayse Akan

Assistant Professor and Clinical Psychologist

Bogazici University

Study Sites (2)

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