NCT07096141

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

April 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

emotion regulationmental healthDBTgroup therapyuniversity student mental healthculturally adapted psychotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (6)

  • Borderline Evaluation of Severity Over Times (BEST)

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

  • Depression Anxiety and Stress Scale (DASS-42)

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

  • Generalised Anxiety Disorder-7 (GAD7)

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

  • Patient Health Questionnaire (PHQ9)

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

  • Outcome Rating Scale (ORS)

    From enrollment to the end of treatment at 8 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Group Session Rating Scale (GSRS)

    From enrollment to the end of treatment at 8 weeks

  • Feedback Form

    Immediately after the intervention

Study Arms (2)

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).

Behavioral: DBT-informed Group Psychotherapy for Emotion Regulation

DBT Waitlist Arm

NO INTERVENTION

DBT waitlist control

Interventions

An 8-session Dialectical Behaviour Therapy informed emotion regulation psychotherapy group.

Also known as: DBT, Group DBT
DBT Experimental Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bogazici University Student Guidance and Psychological Counselling Centre (BUREM)

Istanbul, 34342, Turkey (Türkiye)

RECRUITING

Translational Clinical Psychology Lab

Istanbul, 34342, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Emotional RegulationPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Ayse Akan, DClinPsych

    Bogazici University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Akan, DClinPsych

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Clinical Psychologist

Study Record Dates

First Submitted

April 14, 2025

First Posted

July 31, 2025

Study Start

March 5, 2025

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Locations