NCT06659211

Effectiveness of Mentalization-based Therapy (MBT)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.

Detailed 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).

Conditions

• Severe Mental Illness

Interventions

Type	Name	Description
BEHAVIORAL	Mentalisation-Based Therapy	MBT is conducted according to the treatment manual developed by Bateman \& Fonagy. Patients are offered weekly individual sessions with an MBT therapist for 12 months.
OTHER	Treatment as Usual (TAU)	The TAU group will receive treatment as usual, which in mental health services might include medication, supportive counseling, short therapy, and other limited psychotherapeutic treatments such as DKT. There is no requirement for a frequency of visits for the usual psychiatric care of the TAU group, as this would not be realistic in the current service system, and the usual treatment would not be the usual treatment currently provided.

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-10-26
• Last updated: 2025-04-25

Locations

1 site across 1 country: Finland