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AnxietyUniWELL-CNCT07096154

Improving Emotional Wellbeing of University Students: Anxiety Management

A study testing Group CBT Anxiety Management in people with Anxiety, run by Bogazici University at 2 sites in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety
What is being tested?
Group CBT Anxiety Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesTurkey (Türkiye)
Study dates
4 Mar 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Bogazici University Student Guidance and Psychological Counselling Centre (BUREM)

    Istanbul, 34342

  • Translational Clinical Psychology Lab

    Istanbul, 34342

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read more

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.

Conditions
Anxiety
Being tested
Group CBT Anxiety Management
Keywords
anxiety, group therapy, CBT, university student mental health, mental health, cultural adapted psychotherapy
Medical subject headings
Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group CBT Anxiety ManagementBehavioural

    Also called CBT, Group CBT

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

Study groups in NCT07096154
Study groupRoleWhat they receive
CBT Experimental ArmExperimentalAn 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.
Receives: Behavioral: Group CBT Anxiety Management
CBT Waitlist ArmNo interventionCBT waitlist control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

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

Secondary outcomes (5)

  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".

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

  2. 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".

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

  3. 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".

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

  4. 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.

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Qualitative data

    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:

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

    Measured: Up to 12 weeks following the completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start4 Mar 2025
  3. Primary completion3 Jul 2026
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096154
Sponsor's protocol ID
BAP20022SUP
Acronym
UniWELL-C
Status last verified
Oct 2026
First submitted
14 Apr 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41873829

Questions about this trial

What is this clinical trial studying?

A study testing Group CBT Anxiety Management in people with Anxiety, run by Bogazici University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Anxiety Inventory (BAI) (time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096154, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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