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NCT Number: NCT07096154

Improving Emotional Wellbeing of University Students: Anxiety Management

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 ([email protected]). It is partially funded by Bogazici Scientific Research Projects (20022) and is expected to run for 1-3 years.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bogazici University Student Guidance and Psychological Counselling Centre (BUREM), Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group CBT Anxiety Management

Behavioral

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

Other names: CBT, Group CBT

Primary outcomes

  1. 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

  1. Depression Anxiety and Stress Scale (DASS42)

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

    Depression Anxiety Stress Scale (DASS-42) is a questionnaire that measures the negative emotional states depression, anxiety and stress. Each subscale is scored separately. Each item is rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores for each subscale range from 0 to 42, and the combined total scale ranges from 0 to 126. Higher scores indicate more severity. The severity is categorized into "normal", "mild", "moderate", "severe", and "extremely severe".

  2. Generalised Anxiety Disorder-7 (GAD7)

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

    The Generalised Anxiety Disorder - 7 Scale (GAD7) is a questionnaire used to screen for Generalised Anxiety Disorder and assess the severity of anxiety symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 21. Higher scores indicate more severity. The severity is categorized into "minimal", "mild", "moderate", and "severe".

  3. Patient Health Questionnaire (PHQ9)

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

    The Patient Health Questionnaire (PHQ9) is a scale used for assessing the presence and the severity of depression. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), resulting in a total score that ranges from 0 to 27. Higher scores indicate more severity of depressive symptoms. The severity is categorized into "minimal", "mild", "moderate", "moderately severe" and "severe".

  4. Outcome Rating Scale (ORS)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Outcome Rating Scale (ORS) is a brief 4-item scale used for assessing the members' overall functioning in key areas: individual well-being, interpersonal relationships, social role, and overall well-being. Each item is rated on a visual analog scale from 0 to 10, resulting in a total score between 0 and 40. Higher scores indicate better overall functioning and well-being.

  5. Qualitative data

    Time frame: Up to 12 weeks following the completion of the intervention

    Participants who completed their groups will also be invited to attend a semi-structured interview for in-depth qualitative feedback when they finish the intervention. Below are the sample questions to be asked to the participants:

    • Could you tell us a little about the process (your mental health difficulties) that led you to apply to this group?
    • Were you satisfied with the group?
    • Which parts of the group were useful to you?
    • Which parts of the group need to change (what you didn't like)?
    • How was your relationship with the therapist and assistants?
    • How was your relationship with the other participants of the group?
    • What was the most important thing you learned from the group?
    • Are there any other things that stood out to you?
    • Would you recommend this group to other students with similar problems?
    • Do you think this group should be an ongoing service provided by the university?

Other outcomes

  1. Group Session Rating Scale (GSRS)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Group Session Rating Scale (GSRS) is a brief 4-item scale used for assessing the members' evaluation of each session regarding the therapeutic relationship, goals and topics, approach or method, and overall experience. Each item is rated on a visual analog scale from 0 to 10, resulting in a total score between 0 and 40. Higher scores indicate more satisfaction with the group session.

  2. Feedback Form

    Time frame: Immediately after the intervention

    The client feedback form is a 4-point self-report scale with a free-text box for additional comments. It is used to gather information about participants' experiences with the group facilitator and the intervention. The form includes questions about the therapeutic process, the structure of the sessions, the therapist's approach, and whether the support was helpful.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Akan, DClinPsych

CONTACT

[email protected]

+902123597054

Sponsors and collaborators

Lead sponsor

Bogazici University

Other

Registry information

Official study title

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

Acronym: UniWELL-C

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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