Clinical trial NCT06659211: Effectiveness of Mentalization-based Therapy (MBT)
Official title: Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Mental Illness
Keywords: mentalization, MBT, severe mental disorder, therapy, psychotherapeutic
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
First posted: 2024-10-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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)

Primary outcomes:
measure: Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
timeFrame: baseline, 6, 12 and 18 months
Secondary outcomes:
measure: The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)
timeFrame: baseline, 6, 12 and 18 months
measure: the Inventory of Interpersonal Problems (IIP-32)
timeFrame: baseline, 6, 12 and 18 months
measure: Experiences in Close Relationships Short version (ECR-S)
timeFrame: baseline, 6, 12, and 18 months
measure: Rosenberg Self-Esteem Scale (RSE)
timeFrame: baseline, 6, 12, and 18 months
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: baseline, 6, 12 and 18 months
measure: The Certainty About Mental States Questionnaire (CAMSQ)
timeFrame: baseline, 6, 12 and 18 months
measure: The Reflective Functioning Questionnaire (RFQ)
timeFrame: baseline, 6, 12 and 18 months
measure: Quality of life
timeFrame: baseline, 6, 12 and 18 months
measure: The Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: baseline, 12 months
measure: Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: baseline, 12 months
measure: Clinical Global Impression- Severity scale (CGI-S)
timeFrame: baseline, 12 months
measure: Working Alliance Inventory (WAI)
timeFrame: baseline, 6 and 12 months
measure: Suicidality
timeFrame: from baseline to 18 months
measure: Patient experiences of the treatment
timeFrame: 6 and 12 months
measure: Experiences of recovery
timeFrame: 12 and 18 months
Other outcomes:
measure: Physical symptoms and illnesses
timeFrame: from baseline to 12 months
measure: Need of psychiatric services
timeFrame: from baseline to 12 months
measure: Use of medication
timeFrame: from baseline to 12 months
Locations:
city: Oulu
country: Finland
facility: University Hospital of Oulu
Study officials:
References: