Severe Mental IllnessNCT06659211
Effectiveness of Mentalization-based Therapy (MBT)
A study testing Mentalisation-Based Therapy and Treatment as Usual (TAU) in people with Severe Mental Illness, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Severe Mental Illness
- What is being tested?
- Mentalisation-Based Therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFinland
- Study dates
- 25 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University Hospital of Oulu
Oulu
Jenni Vähä, MSc, +358 50 479 2161, jenni.vaha@pohde.fi
Erika Jääskeläinen, MD, PhD, +358407191146, erika.jaaskelainen@oulu.fi
About this study
Official title: Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study
The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.
Read the 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).
- Conditions
- Severe Mental Illness
- Being tested
- Mentalisation-Based Therapy, Treatment as Usual (TAU)
- Keywords
- mentalization, MBT, severe mental disorder, therapy, psychotherapeutic
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalisation-Based TherapyBehavioural
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mentalisation-Based Therapy |
| 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6, 12 and 18 months
Secondary outcomes (15)
The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)
questionnaire assessing personality
Measured: baseline, 6, 12 and 18 months
the Inventory of Interpersonal Problems (IIP-32)
Questionnaire on interpersonal problems
Measured: baseline, 6, 12 and 18 months
Experiences in Close Relationships Short version (ECR-S)
Measures experiences in close relationships
Measured: baseline, 6, 12, and 18 months
Rosenberg Self-Esteem Scale (RSE)
Questionnaire on self-esteem
Measured: baseline, 6, 12, and 18 months
Emotion Regulation Questionnaire (ERQ)
Measure of emotion regulation
Measured: baseline, 6, 12 and 18 months
The Certainty About Mental States Questionnaire (CAMSQ)
Questionnaire on perceived capacity of mentalising oneself and others.
Measured: baseline, 6, 12 and 18 months
The Reflective Functioning Questionnaire (RFQ)
a brief measure of reflective functioning, i.e. mentalizing
Measured: baseline, 6, 12 and 18 months
Quality of life
WHO 1 question
Measured: 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.
Measured: 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)
Measured: 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)
Measured: baseline, 12 months
Working Alliance Inventory (WAI)
Questionnaire on therapeutic alliance. Higher scores indicate better alliance.
Measured: baseline, 6 and 12 months
Suicidality
from questionnaires and medical records
Measured: 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
Measured: 6 and 12 months
Experiences of recovery
Questions on experience of change of health status and recovery
Measured: 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start25 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659211
- Sponsor's protocol ID
- 240/2024
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study
- ClinicalTrials.gov ID
- NCT06659211
- Acronym / sponsor ID
- 240/2024
- Conditions
- Severe Mental Illness
- Keywords
- mentalization, MBT, severe mental disorder, therapy, psychotherapeutic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalisation-Based Therapy | Experimental | Behavioral: Mentalisation-Based TherapyMBT 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 | 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalisation-Based TherapyMBT is conducted according to the treatment manual developed by Bateman \& Fonagy. Patients are offered weekly individual sessions with an MBT therapist for 12 months. | Behavioural | Mentalisation-Based Therapy |
| 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. | Other | Treatment as usual |
Primary outcome
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
Time frame: baseline, 6, 12 and 18 months
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.
15 secondary outcomes
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
Suicidality
Time frame: from baseline to 18 months
Patient experiences of the treatment
Time frame: 6 and 12 months
Experiences of recovery
Time frame: 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalisation-Based Therapy and Treatment as Usual (TAU) in people with Severe Mental Illness, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenni Vähä, MSc (800-555-5555, jenni.vaha@pohde.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) (time frame: baseline, 6, 12 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.