Emotion RegulationUniWELL-DNCT07096141
Improving Emotional Wellbeing of University Students: Emotion Regulation
A study testing DBT-informed Group Psychotherapy for Emotion Regulation in people with Emotion Regulation, run by Bogazici University at 2 sites in Turkey (Türkiye).
Trial summary
University students' psychological well-being is a growing public health concern. University life involves major psychological, social, and academic changes, increasing vulnerability to mental health issues. Group-based Dialectical Behaviour Therapy (DBT) has been shown to support student well-being effectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- DBT-informed Group Psychotherapy for Emotion Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 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 Difficulties in Emotion Regulation Scale (DERS-16).
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 on the Difficulties in Emotion Regulation Scale (DERS-16).
- 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
About this study
Official title: Improving Emotional Wellbeing of University Students Using Culturally Adapted Dialectic Behaviour Approaches in Group Settings" (UniWELL-D): Protocol of a Feasibility and Effectiveness Study
University students' psychological well-being is a growing public health concern. University life involves major psychological, social, and academic changes, increasing vulnerability to mental health issues. Group-based Dialectical Behaviour Therapy (DBT) has been shown to support student well-being effectively. However, interventions tailored to specific cultural and contextual needs are more likely to be helpful. Western-based therapy models may not fully align with non-Western populations, such as students in Türkiye.
In Türkiye, public mental health services are often limited to short psychiatric consultations, while therapy is typically accessed privately. University counselling centres offering free or low-cost therapy are therefore essential. Cost-effective interventions like group DBT may be especially valuable in these settings. To address this gap, culturally adapted DBT groups should be developed and evaluated for Turkish university students.
Read more
This study is part of the UniWELL Project (sister to UniWELL-C) and examines the effectiveness of DBT-informed emotion regulation groups for Turkish students. Any Bogazici University student aged 18+ is eligible. Exclusion criteria include severe mental illness, high risk of harm to self/others, or scoring below threshold on the Difficulties in Emotion Regulation Scale (DERS-16), as these students may require more individual support.
The study includes participation in an 8-session DBT-informed group. Participants are expected to benefit from free psychological support, guided reflection, and shared experiences with peers. The research will also contribute to the evidence base for culturally adapted interventions.
There are some risks: participants may feel overwhelmed during the sessions or while completing questionnaires. If so, support will be provided by a clinical psychology master's student and/or the group facilitator, under supervision of an experienced clinical psychologist. If a participant's risk increases, they will be referred to psychiatric services. An emergency contact will be requested to ensure safety if needed.
The study will take place at Bogazici University through the Translational Clinical Psychology Lab, in collaboration with BUREM. It is expected to run for at least one year, possibly extending up to three years. The study is partially funded by the Bogazici Scientific Research Projects Unit (20022). Dr Ayse Akan (t-clinpsylab@bogazici.edu.tr) is the study lead and main contact.
- Conditions
- Emotion Regulation
- Being tested
- DBT-informed Group Psychotherapy for Emotion Regulation
- Keywords
- emotion regulation, mental health, DBT, group therapy, university student mental health, culturally adapted psychotherapy
- Medical subject headings
- Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-informed Group Psychotherapy for Emotion RegulationBehavioural
Also called DBT, Group DBT
An 8-session Dialectical Behaviour Therapy informed emotion regulation psychotherapy group.
| Study group | Role | What they receive |
|---|---|---|
| DBT Experimental Arm | Experimental | An 8-session Dialectical Behaviour Therapy informed emotional regulation group psychotherapy will be offered to the experimental group of about 40 university students who volunteered and scored above the threshold on the Difficulties in Emotion Regulation Scale (DERS-16). Receives: Behavioral: DBT-informed Group Psychotherapy for Emotion Regulation |
| DBT Waitlist Arm | No intervention | DBT waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS-16)
Difficulties in Emotion Regulation Scale (DERS-16) is a questionnaire that measures different aspects of difficulties in emotion, including emotional awareness, clarity, acceptance, impulse control, and goal-directed behavior during emotional distress. Each item is scored on a 5-point Likert scale, from 1 (almost never) to 5 (almost always), resulting in a total score range of 16 to 80. Higher scores indicate greater difficulties in emotion regulation.
Measured: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion intervention
Secondary outcomes (6)
Borderline Evaluation of Severity Over Times (BEST)
The Borderline Evaluation of Severity Over Times (BEST) is a tool that measures the severity and progression of thoughts, feelings, and behaviors that are typical of Borderline Personality Disorder. Each item is rated on a 5-point Likert scale, where 1 indicates none/rarely and 5 indicates almost always, resulting in a total score range between 12 and 72. Higher scores indicate more severe symptoms. The scale also provides information about positive behaviors separately.
Measured: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion intervention
Depression Anxiety and Stress Scale (DASS-42)
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
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
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
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
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:
- 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?
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.
- First posted31 Jul 2025
- Study start5 Mar 2025
- Primary completion3 Jul 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bogazici University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Akan, Bogazici University
- Investigators
- Ayse Akan, DClinPsych, Principal investigator, Bogazici University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096141
- Sponsor's protocol ID
- 20022
- Acronym
- UniWELL-D
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Emotional Wellbeing of University Students Using Culturally Adapted Dialectic Behaviour Approaches in Group Settings" (UniWELL-D): Protocol of a Feasibility and Effectiveness Study
- ClinicalTrials.gov ID
- NCT07096141
- Acronym / sponsor ID
- UniWELL-D / 20022
- Conditions
- Emotion Regulation
- Keywords
- emotion regulation, mental health, DBT, group therapy, university student mental health, culturally adapted psychotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bogazici UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
University students' psychological well-being is a growing public health concern. University life involves major psychological, social, and academic changes, increasing vulnerability to mental health issues. Group-based Dialectical Behaviour Therapy (DBT) has been shown to support student well-being effectively. However, interventions tailored to specific cultural and contextual needs are more likely to be helpful. Western-based therapy models may not fully align with non-Western populations, such as students in Türkiye.
In Türkiye, public mental health services are often limited to short psychiatric consultations, while therapy is typically accessed privately. University counselling centres offering free or low-cost therapy are therefore essential. Cost-effective interventions like group DBT may be especially valuable in these settings. To address this gap, culturally adapted DBT groups should be developed and evaluated for Turkish university students.
This study is part of the UniWELL Project (sister to UniWELL-C) and examines the effectiveness of DBT-informed emotion regulation groups for Turkish students. Any Bogazici University student aged 18+ is eligible. Exclusion criteria include severe mental illness, high risk of harm to self/others, or scoring below threshold on the Difficulties in Emotion Regulation Scale (DERS-16), as these students may require more individual support.
The study includes participation in an 8-session DBT-informed group. Participants are expected to benefit from free psychological support, guided reflection, and shared experiences with peers. The research will also contribute to the evidence base for culturally adapted interventions.
There are some risks: participants may feel overwhelmed during the sessions or while completing questionnaires. If so, support will be provided by a clinical psychology master's student and/or the group facilitator, under supervision of an experienced clinical psychologist. If a participant's risk increases, they will be referred to psychiatric services. An emergency contact will be requested to ensure safety if needed.
The study will take place at Bogazici University through the Translational Clinical Psychology Lab, in collaboration with BUREM. It is expected to run for at least one year, possibly extending up to three years. The study is partially funded by the Bogazici Scientific Research Projects Unit (20022). Dr Ayse Akan (t-clinpsylab@bogazici.edu.tr) is the study lead and main contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DBT Experimental Arm | Experimental | Behavioral: DBT-informed Group Psychotherapy for Emotion RegulationAn 8-session Dialectical Behaviour Therapy informed emotional regulation group psychotherapy will be offered to the experimental group of about 40 university students who volunteered and scored above the threshold on the Difficulties in Emotion Regulation Scale (DERS-16). |
| DBT Waitlist Arm | No intervention | –DBT waitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be a Bogazici University student.
- Must be 18 years or older.
- Must score above the threshold on the Difficulties in Emotion Regulation Scale (DERS-16).
Key exclusion criteria (5 listed)
- Not Bogazici University student.
- Has serious and severe mental illness.
- High risk of self-harm/harm to others.
- Scoring below the threshold of on the Difficulties in Emotion Regulation Scale (DERS-16).
- Younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT-informed Group Psychotherapy for Emotion RegulationAlso: DBT, Group DBTAn 8-session Dialectical Behaviour Therapy informed emotion regulation psychotherapy group. | Behavioural | DBT Experimental Arm |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion intervention
Difficulties in Emotion Regulation Scale (DERS-16) is a questionnaire that measures different aspects of difficulties in emotion, including emotional awareness, clarity, acceptance, impulse control, and goal-directed behavior during emotional distress. Each item is scored on a 5-point Likert scale, from 1 (almost never) to 5 (almost always), resulting in a total score range of 16 to 80. Higher scores indicate greater difficulties in emotion regulation.
6 secondary outcomes
Borderline Evaluation of Severity Over Times (BEST)
Time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion intervention
Depression Anxiety and Stress Scale (DASS-42)
Time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention
Generalised Anxiety Disorder-7 (GAD7)
Time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention
Patient Health Questionnaire (PHQ9)
Time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention
Outcome Rating Scale (ORS)
Time frame: From enrollment to the end of treatment at 8 weeks
Qualitative data
Time frame: Up to 12 weeks following the completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 41873829Akan 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Akan, DClinPsych principal investigator
Bogazici University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-informed Group Psychotherapy for Emotion Regulation in people with Emotion Regulation, 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?
Difficulties in Emotion Regulation Scale (DERS-16) (time frame: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion 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 NCT07096141, 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.