Effectiveness of Mentalization-based Therapy (MBT)

Last updated: April 22, 2025
Sponsor: Oulu University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizotypal Personality Disorder (Spd)

Treatment

Mentalisation-Based Therapy

Treatment as Usual (TAU)

Clinical Study ID

NCT06659211
240/2024
  • Ages 18-64
  • All Genders

Study 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

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) oranxiety 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) oranxiety disorder (diagnosis codes: F40-F48)

  • Trauma background either as diagnosis or as need for treatment

  • Signs of personality disorder (suspected or diagnosed)

Exclusion

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, orpsychotic disorder F1x.5).

  • Acute psychosis (defined as the recent onset of severe psychotic symptoms thatinterfere with functioning and are not yet in a therapeutic state. Non-acutepsychotic symptoms are not exclusionary)

  • Disorder requiring inpatient treatment

  • Previously received MBT

  • Currently receiving psychotherapeutic treatment (previous psychotherapeutictreatment 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, orpsychotic disorder F1x.5).

  • Acute psychosis (defined as the recent onset of severe psychotic symptoms thatinterfere with functioning and are not yet in a therapeutic state. Non-acutepsychotic symptoms are not exclusionary)

  • Disorder requiring inpatient treatment

  • Previously received MBT

  • Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weeklylong-term psychotherapy)

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Mentalisation-Based Therapy
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
June 30, 2026

Study Description

Background: Mentalization-based therapy (MBT) has a growing evidence base as a group treatment, and research on MBT as an individual treatment is needed. This study will provide crucial new information on its effectiveness and usability in everyday patient care.

Methods: The study design will be an non-randomized clinical pilot study. We will study the effectiveness of MBT and analyze which factors are associated with better effectiveness. The length of intervention will be 12 months. The primary outcome measure is the change in psychological symptoms and well-being from the beginning to the end of MBT treatment, measured by CORE-OM. Secondary outcomes include several measures of symptoms, functioning, quality of life, and mentalization. Outcomes will be assessed at 6, 12 and 18 months. The study group will comprise of 64 patients receiving MBT. For comparison, patient group (n=64) with similar characteristics (age, gender, diagnosis) receiving treatment as usual (TAU) in psychiatric services will be ascertained from medical records, and their outcomes after 12 months of treatment will be compared to that of MBT -group.

Intervention / Treatment: Behavioral: Mentalization-based treatment/therapy

Participation criteria: Patients are not strictly limited to a specific disease/diagnostic group. This choice has been made because there is an increasing need in the mental health care for the treatment and therapy of this multi-symptom and severely symptomatic patient group, which also makes the results of the study more applicable to a real life. Patients will be selected for the MBT and TAU based on inclusion and exclusion criteria and patients preference. In addition, the selection to MBT will be made by a trained MBT therapist, who will assess the patient's suitability for MBT (e.g., patient willing to engage in active psychotherapeutic work, interested in the inner world of experience, willing to work interactively).

Connect with a study center

  • University Hospital of Oulu

    Oulu,
    Finland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.