Improving Emotional Wellbeing of University Students: Anxiety Management
ConditionAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBogazici University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be a Bogazici University student.
Must be 18 years or older.
Must score above the threshold on the Beck Anxiety Inventory.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Group CBT Anxiety Management
BehavioralAn 8-session Group Cognitive Behavioural Therapy for anxiety management.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CBT Experimental ArmExperimental treatment 1 intervention
Group B: CBT Waitlist ArmNo intervention 0 interventions
Trial outcomes
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".
Time frame
Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the interventionSecondary outcomes
1
Depression Anxiety and Stress Scale (DASS42)
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".
Time frame
Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention2
Generalised Anxiety Disorder-7 (GAD7)
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".
Time frame
Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention3
Patient Health Questionnaire (PHQ9)
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".
Time frame
Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention4
Outcome Rating Scale (ORS)
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.
Time frame
From enrollment to the end of treatment at 8 weeksOther outcomes
1
Group Session Rating Scale (GSRS)
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
Feedback Form
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.
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov