Effectiveness of Mentalization-based Therapy (MBT)

NCT06659211 | Recruiting

• 1 other identifier: 240/2024
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Illness

Keywords

mentalization, MBT, severe mental disorder, therapy, psychotherapeutic

Outcome Measures

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.

  baseline, 6, 12 and 18 months

Secondary Outcomes (15)

• The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)

  baseline, 6, 12 and 18 months

• the Inventory of Interpersonal Problems (IIP-32)

  baseline, 6, 12 and 18 months

• Experiences in Close Relationships Short version (ECR-S)

  baseline, 6, 12, and 18 months

• Rosenberg Self-Esteem Scale (RSE)

  baseline, 6, 12, and 18 months

• Emotion Regulation Questionnaire (ERQ)

  baseline, 6, 12 and 18 months

Other Outcomes (3)

• Physical symptoms and illnesses

  from baseline to 12 months

• Need of psychiatric services

  from baseline to 12 months

• Use of medication

  from baseline to 12 months

Study Arms (2)

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.

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.

Other: Treatment as Usual (TAU)

Interventions

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.

Mentalisation-Based Therapy

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).
• Disorder requiring inpatient treatment
• Previously received MBT
• 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).
• Disorder requiring inpatient treatment
• Previously received MBT
• Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weekly long-term psychotherapy)

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Oulu: collaborator

Study Sites (1)

University Hospital of Oulu

Oulu, Finland

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Central Study Contacts

Jenni Vähä, MSc

CONTACT

800-555-5555; jenni.vaha@pohde.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 26, 2024
• Study Start: September 25, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)