NCT06659211 Effectiveness of Mentalization-based Therapy (MBT)
| NCT ID | NCT06659211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Severe Mental Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2024-09-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.
Eligibility Criteria
Inclusion Criteria: MBT Group: * Age 18-64 years. * Severe psychological symptoms, decreased functioning ability for long-term * Challenges with interpersonal relationships and emotional regulation * Patients willing to receive MBT * At least two of the following: * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48) * Trauma background either as diagnosis or as need for treatment * Signs of personality disorder (suspected or diagnosed) TAU group: * Age 18-64 years. * Severe psychological symptoms, decreased functioning ability for long-term * Challenges with interpersonal relationships and emotional regulation * At least two of the following * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48) * Trauma background either as diagnosis or as need for treatment * Signs of personality disorder (suspected or diagnosed) Exclusion Criteria: MBT Group: * Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5). * Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary) * Disorder requiring inpatient treatment * Previously received MBT * Currently receiving psychotherapeutic treatment (previous psychotherapeutic treatment is not an exclusion) The exclusion criteria, therefore, do not exclude psychotic disorders or any other psychiatric illness (except substance abuse disorders). TAU group: * Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5). * Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary) * Disorder requiring inpatient treatment * Previously received MBT * Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weekly long-term psychotherapy)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06659211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Severe Mental Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659211 currently recruiting?
Yes, NCT06659211 is actively recruiting participants. Contact the research team at jenni.vaha@pohde.fi for enrollment information.
Where is the NCT06659211 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT06659211 clinical trial?
NCT06659211 is sponsored by Oulu University Hospital. The trial plans to enroll 128 participants.