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| Name | Class |
|---|---|
| University of Oulu | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mentalisation-Based Therapy | Experimental | 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. |
|
| Treatment as usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentalisation-Based Therapy | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
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:
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
Exclusion Criteria:
MBT Group:
The exclusion criteria, therefore, do not exclude psychotic disorders or any other psychiatric illness (except substance abuse disorders).
TAU group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenni Vähä, MSc | Contact | 800-555-5555 | jenni.vaha@pohde.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Oulu | Recruiting | Oulu | Finland |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual (TAU) | Other | 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. |
|
| 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 |
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 |