The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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.
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.
University Hospital of Oulu
Oulu, Finland
RECRUITINGClinical 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 months
The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)
questionnaire assessing personality
Time frame: baseline, 6, 12 and 18 months
the Inventory of Interpersonal Problems (IIP-32)
Questionnaire on interpersonal problems
Time frame: baseline, 6, 12 and 18 months
Experiences in Close Relationships Short version (ECR-S)
Measures experiences in close relationships
Time frame: baseline, 6, 12, and 18 months
Rosenberg Self-Esteem Scale (RSE)
Questionnaire on self-esteem
Time frame: baseline, 6, 12, and 18 months
Emotion Regulation Questionnaire (ERQ)
Measure of emotion regulation
Time frame: baseline, 6, 12 and 18 months
The Certainty About Mental States Questionnaire (CAMSQ)
Questionnaire on perceived capacity of mentalising oneself and others.
Time frame: baseline, 6, 12 and 18 months
The Reflective Functioning Questionnaire (RFQ)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
a brief measure of reflective functioning, i.e. mentalizing
Time frame: baseline, 6, 12 and 18 months
Quality of life
WHO 1 question
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: baseline, 12 months
Working Alliance Inventory (WAI)
Questionnaire on therapeutic alliance. Higher scores indicate better alliance.
Time frame: baseline, 6 and 12 months
Suicidality
from questionnaires and medical records
Time frame: 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
Time frame: 6 and 12 months
Experiences of recovery
Questions on experience of change of health status and recovery
Time frame: 12 and 18 months