Effectiveness of Mentalization-based Therapy (MBT)
ConditionSevere Mental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorOulu University Hospital
About this trial
The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mentalisation-Based Therapy
BehavioralMBT is conducted according to the treatment manual developed by Bateman \& Fonagy. Patients are offered weekly individual sessions with an MBT therapist for 12 months.
Treatment as Usual (TAU)
Other interventionThe 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Mentalisation-Based TherapyExperimental treatment 1 intervention
Group B: Treatment as usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, 6, 12 and 18 monthsSecondary outcomes
1
The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)
questionnaire assessing personality
Time frame
baseline, 6, 12 and 18 months2
the Inventory of Interpersonal Problems (IIP-32)
Questionnaire on interpersonal problems
Time frame
baseline, 6, 12 and 18 months3
Experiences in Close Relationships Short version (ECR-S)
Measures experiences in close relationships
Time frame
baseline, 6, 12, and 18 months4
Rosenberg Self-Esteem Scale (RSE)
Questionnaire on self-esteem
Time frame
baseline, 6, 12, and 18 monthsOther outcomes
1
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).
Time frame
from baseline to 12 months2
Need of psychiatric services
Number of outpatient, inpatient and emergency visits. Data from medical records.
Time frame
from baseline to 12 months3
Use of medication
Use of psychiatric medications. Data from medical records.
Time frame
from baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oulu University Hospital
Lead sponsor
University of Oulu
Collaborator
Source ClinicalTrials.gov