NCT07096154

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
20mo left

Started Mar 2025

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress42%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 4, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

April 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

anxietygroup therapyCBTuniversity student mental healthmental healthcultural adapted psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Inventory (BAI)

    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".

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

Secondary Outcomes (5)

  • 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

Other Outcomes (2)

  • Group Session Rating Scale (GSRS)

    From enrollment to the end of treatment at 8 weeks

  • Feedback Form

    Immediately after the intervention

Study Arms (2)

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.

Behavioral: Group CBT Anxiety Management

CBT Waitlist Arm

NO INTERVENTION

CBT waitlist control

Interventions

An 8-session Group Cognitive Behavioural Therapy for anxiety management.

Also known as: CBT, Group CBT
CBT Experimental Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bogazici University Student Guidance and Psychological Counselling Centre (BUREM)

Istanbul, 34342, Turkey (Türkiye)

RECRUITING

Translational Clinical Psychology Lab

Istanbul, 34342, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Akan A, Korkut NH. Improving the emotional wellbeing of university students through culturally adapted cognitive and dialectical behavioral group interventions: protocol for two parallel feasibility and effectiveness studies. Transl Behav Med. 2026 Jan 7;16(1):ibag010. doi: 10.1093/tbm/ibag010.

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Ayse Akan, DClinPsych

    Bogazici University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Akan, DClinPsych

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-centre interventional non-blinded mixed-methods non-randomised pre-post design with a waitlist control and 6 weeks follow-up feasibility and psychotherapy effectiveness study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Clinical Psychologist

Study Record Dates

First Submitted

April 14, 2025

First Posted

July 31, 2025

Study Start

March 4, 2025

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The anonymised quantitative data will be kept securely on a password protected drive for 10 years and will be shared with peer-reviewers if requested, while the qualitative interview transcripts will also be kept securely on a password protected drive but they will not be shared with peer-reviewers (will be only open to the research team) until it is deleted after 10 years. Some of the research team may use these data in secondary analysis projects.

Time Frame
The data supporting this study's findings will be available from the corresponding author upon reasonable request, starting immediately after publication. Data will be maintained and available for 10 years after the last data collection.
Access Criteria
Being a peer-reviewer / researcher

Locations