Evaluating the effectiveness of mentalization-based therapy for severe mental illness

Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study

This study is testing whether mentalization-based therapy can help people with severe mental disorders feel better compared to those getting standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Oulu University Hospital (Academic / other)
• Locations: 1 site (Oulu)
• Trial ID: NCT06659211 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of mentalization-based therapy (MBT) for individuals with severe mental disorders who are seeking help from mental health services. It is a non-randomized clinical pilot study involving 64 patients receiving MBT, with outcomes compared to a control group of 64 patients receiving treatment as usual (TAU). The intervention lasts for 12 months, and the primary outcome will assess changes in psychological symptoms and well-being using the CORE-OM measure, with additional evaluations at 6, 12, and 18 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 with severe psychological symptoms and challenges in emotional regulation and interpersonal relationships.

Not a fit: Patients with mild symptoms or those not willing to engage in therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve psychological symptoms and overall well-being for patients with severe mental illness.

How similar studies have performed: Previous studies have shown promising results for mentalization-based therapy, particularly in group settings, but this individual approach is less explored.

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)

Where this trial is running

Oulu

• University Hospital of Oulu — Oulu, Finland (Recruiting)

Study contacts

• Study coordinator: Jenni Vähä, MSc

Conditions Severe Mental Illness; mentalization, MBT, severe mental disorder, therapy, psychotherapeutic