ClinicalTrials.gg
Active, not recruitingNCT07096154UniWELL-CUpdated Oct 28, 2026

Improving Emotional Wellbeing of University Students: Anxiety Management

An interventional study of Group CBT Anxiety Management in Anxiety, sponsored by Bogazici University. Active, not recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Bogazici University · Not applicable, Interventional, and Treatment

Updated Oct 28, 2026Now Active, not recruitingGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety

Browse trials for

Keywords

  • anxiety
  • group therapy
  • CBT
  • university student mental health
  • mental health
  • cultural adapted psychotherapy
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Bogazici University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Not Bogazici University student.
  2. Has serious and severe mental illness.
  3. High risk of self-harm/harm to others.
  4. Scoring below the threshold of the Beck Anxiety Inventory.
  5. Younger than 18 years old.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CBT Experimental Arm

    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

  • No intervention
    CBT Waitlist Arm

    CBT waitlist control

Interventions

  • BehavioralGroup CBT Anxiety Management

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

    Also known as: CBT, Group CBT

06

What researchers measure

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 intervention

Secondary 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 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".

    Time frame: 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".

    Time frame: 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.

    Time frame: 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?

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

Other 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 weeks

  2. 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 intervention

07

Study locations

2 sites
  • Bogazici University Student Guidance and Psychological Counselling Centre (BUREM)
    Istanbul, 34342, Turkey (Türkiye)
  • Translational Clinical Psychology Lab
    Istanbul, 34342, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

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

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2025 to primary completion in Jul 2026, 15 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 15 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2025
First posted
Jul 31, 2025
StartActual
Mar 4, 2025
Primary completionActual
Jul 3, 2026
CompletionEst.
Dec 31, 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Recruiting→Active, not recruiting
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07096154
Lead sponsor
Bogazici University
Responsible party
Ayse Akan (Assistant Professor and Clinical Psychologist, Bogazici University) — Principal investigator
First posted
Jul 31, 2025
Start date
Mar 4, 2025
Primary completion
Jul 3, 2026
Completion
Dec 31, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Ayse Akan, DClinPsych
principal investigator · Bogazici University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion