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Recruiting NCT06659211

Effectiveness of Mentalization-based Therapy (MBT)

No phase Interventional Severe Mental Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mentalisation-Based Therapy, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Severe Mental Illness. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) [Time frame: baseline, 6, 12 and 18 months]
Secondary outcome measures (12)
  • The Big Five Inventory-2 Extra-Short Form (BFI-2-XS) [Time frame: baseline, 6, 12 and 18 months]
  • the Inventory of Interpersonal Problems (IIP-32) [Time frame: baseline, 6, 12 and 18 months]
  • Experiences in Close Relationships Short version (ECR-S) [Time frame: baseline, 6, 12, and 18 months]
  • Rosenberg Self-Esteem Scale (RSE) [Time frame: baseline, 6, 12, and 18 months]
  • Emotion Regulation Questionnaire (ERQ) [Time frame: baseline, 6, 12 and 18 months]
  • The Certainty About Mental States Questionnaire (CAMSQ) [Time frame: baseline, 6, 12 and 18 months]
  • The Reflective Functioning Questionnaire (RFQ) [Time frame: baseline, 6, 12 and 18 months]
  • Quality of life [Time frame: baseline, 6, 12 and 18 months]
  • The Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: baseline, 12 months]
  • Social and Occupational Functioning Assessment Scale (SOFAS) [Time frame: baseline, 12 months]
  • Clinical Global Impression- Severity scale (CGI-S) [Time frame: baseline, 12 months]
  • Working Alliance Inventory (WAI) [Time frame: baseline, 6 and 12 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • University Hospital of Oulu — Oulu

Identifiers

NCT: NCT06659211 · 240/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗