Actively Recruiting
Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study
Led by Oulu University Hospital · Updated on 2025-04-25
128
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
O
Oulu University Hospital
Lead Sponsor
U
University of Oulu
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of mentalization-based therapy (MBT) among adults with severe mental illnesses who seek help from mental health services. This pilot study aims to evaluate the effectiveness and usability of MBT as an individual treatment over 12 months, comparing it to treatment as usual (TAU). The study focuses on changes in psychological symptoms and well-being measured by the CORE-OM, along with other assessments of symptoms, functioning, quality of life, and mentalization abilities. Participants in the MBT group will receive weekly individual therapy sessions based on a manual developed by Bateman and Fonagy over a 12-month period. The TAU group will receive standard psychiatric care, which may include medication, supportive counseling, short therapy, or other limited psychotherapeutic treatments without a fixed visit schedule. The study includes 64 patients in each group, with outcomes compared after 12 months of treatment. Participants will be evaluated at baseline, 6, 12, and 18 months using various psychological scales and questionnaires, including measures of depression, self-esteem, emotion regulation, social functioning, and suicidality. Patient experiences and recovery will also be tracked. The study involves monitoring clinical outcomes and mental health improvements while participants continue their usual care. The total participation time includes assessments up to 18 months from the start of treatment.
CONDITIONS
Brief Title
Effectiveness of Mentalization-based Therapy (MBT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 years
- Severe psychological symptoms and long-term decreased functioning
- Challenges with interpersonal relationships and emotional regulation
- Willingness to receive Mentalization-Based Therapy (MBT) for MBT group
- At least two of the following: depression or anxiety disorder, trauma background, signs of personality disorder
- Similar criteria for Treatment as Usual (TAU) group except willingness to receive MBT
You will not qualify if you...
- Active substance use disorder or physiological withdrawal state
- Acute psychosis interfering with functioning and not yet treated
- Disorder requiring inpatient treatment
- Previous receipt of Mentalization-Based Therapy (MBT)
- Currently receiving psychotherapeutic treatment for MBT group
- Intensive psychotherapy for TAU group (e.g., weekly long-term rehabilitative psychotherapy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive weekly individual Mentalization-Based Therapy (MBT) sessions for 12 months to improve psychological symptoms and well-being.
Weekly visits for up to 12 months
Duration - Up to 6 months after treatment ends
Participants complete outcome assessments at 6, 12, and 18 months to evaluate symptom changes, functioning, and quality of life after treatment.
3 visits (at 6, 12, and 18 months)
Trial Site Locations
Total: 1 location
1
University Hospital of Oulu
Oulu, Finland
Actively Recruiting
Research Team
J
Jenni Vähä, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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