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

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

Study Overview

• Status: Recruiting
• Conditions: Severe Mental Illness
• Intervention / Treatment: Behavioral: Mentalisation-Based Therapy; Other: Treatment as Usual (TAU)

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).

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenni Vähä, MSc; Phone Number: 800-555-5555; Email: jenni.vaha@pohde.fi

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • University Hospital of Oulu
    • Contact: Jenni Vähä, MSc; Phone Number: +358 50 479 2161; Email: jenni.vaha@pohde.fi
    • Contact: Erika Jääskeläinen, MD, PhD; Phone Number: +358407191146; Email: erika.jaaskelainen@oulu.fi
    • Contact: Erika Jääskeläinen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Treatment as usual; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)	A self-report measure of psychological distress and symptoms. Higher scores indicates worse outcomes. Includes four main domains: wellbeing, problems, functioning and risk (to self or others). Based on detailed instructions on calculating the scores, clinical score minimun 0 and maximum 40.	baseline, 6, 12 and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)	questionnaire assessing personality	baseline, 6, 12 and 18 months
the Inventory of Interpersonal Problems (IIP-32)	Questionnaire on interpersonal problems	baseline, 6, 12 and 18 months
Experiences in Close Relationships Short version (ECR-S)	Measures experiences in close relationships	baseline, 6, 12, and 18 months
Rosenberg Self-Esteem Scale (RSE)	Questionnaire on self-esteem	baseline, 6, 12, and 18 months
Emotion Regulation Questionnaire (ERQ)	Measure of emotion regulation	baseline, 6, 12 and 18 months
The Certainty About Mental States Questionnaire (CAMSQ)	Questionnaire on perceived capacity of mentalising oneself and others.	baseline, 6, 12 and 18 months
The Reflective Functioning Questionnaire (RFQ)	a brief measure of reflective functioning, i.e. mentalizing	baseline, 6, 12 and 18 months
Quality of life	WHO 1 question	baseline, 6, 12 and 18 months
The Montgomery-Åsberg Depression Rating Scale (MADRS)	Interview based rating of depression symptoms and their severity. Minimum: 0 Maximum: 60 Higher scores indicate more severe symptoms.	baseline, 12 months
Social and Occupational Functioning Assessment Scale (SOFAS)	Clinician/investigator rated measure of social and occupational functioning. Minimum value: 0 (Inadequate information), 1 (worst functioning, unable to function, persistent inability) Maximum value: 100 (Superior functioning in a wide range of activities)	baseline, 12 months
Clinical Global Impression- Severity scale (CGI-S)	Clinical Global Impression of the severity of illness. Minimum value: 1 (normal, not at all ill) Maximum value: 7 (amongst the most severely ill)	baseline, 12 months
Working Alliance Inventory (WAI)	Questionnaire on therapeutic alliance. Higher scores indicate better alliance.	baseline, 6 and 12 months
Suicidality	from questionnaires and medical records	from baseline to 18 months
Patient experiences of the treatment	questions on how the patient has experienced the intervention, and if he/she has experienced the treatment as beneficial	6 and 12 months
Experiences of recovery	Questions on experience of change of health status and recovery	12 and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical symptoms and illnesses	Information collected from the medical records. Data on physical symptoms or diagnosed physical illnesses, that the patient complains or seeks help will be collected from the medical records (visits to mental health care and somatic care).	from baseline to 12 months
Need of psychiatric services	Number of outpatient, inpatient and emergency visits. Data from medical records.	from baseline to 12 months
Use of medication	Use of psychiatric medications. Data from medical records.	from baseline to 12 months

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: mentalization, MBT, severe mental disorder, therapy, psychotherapeutic
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 240/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No