Reflective Functioning and Psychotherapy Processes in MBT

NCT04157907 | Unknown

• 1 other identifier: 2018/0519
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Borderline personality disorder (BPD) is a pervasive mental disorder characterized by emotional instability, self-destructive behavior, identity problems and unstable relationships. Persons with this disorder usually experience significant distress in terms of depression, anxieties, suicidal behavior, and difficulties in close relationships as well as with work- and social functioning. Recent research has found the prognosis of BPD to be better than previously assumed, and many patients improve from treatment. Mentalization based therapy (MBT) is a specialized evidenced based therapy for patients with BPD. Like for other specialized treatments for this disorder, the outcome of therapy is typically variable, some patients respond well to treatment, whereas others respond less. It is therefore important to understand how treatment works in order to improve therapies and tailor treatment to individual patients. Mentalizing is the ability to understand ourselves and others in terms of mental states, like intentions, feelings, desires, attitudes, and so on, or briefly; the ability to mind own and other's minds. Impaired mentalizing capacity is an assumed core aspect of BPD, underlying many of the symptoms of this disorder. MBT focuses on the patients mentalizing difficulties and is typically offered as a long-term combined treatment program comprising individual and group therapy, as well as psychoeducation. Several studies have documented positive effects of MBT in terms of reduced suicidal behavior, symptoms, interpersonal problems, medication, and health service use. It is assumed that such clinical improvement is made possible by helping the patients to develop their mentalizing abilities. Yet, no study has investigated whether patients' mentalizing capacity changes during MBT, or to what degree outcome of MBT is mediated by improved mentalizing. Mentalizing is, however, a complex phenomenon and difficult to measure. Research in this area has been hampered by a lack of suitable methods. Mentalizing is usually operationalized as Reflective Functioning (RF) assessed by the RF Scale. The gold standard is to apply the RF Scale on the Adult Attachment Interview. However, this is a time consuming and costly method, and there is a need for testing other methods as well. The overall aim of the project is to study treatment processes in MBT for patients with BPD. It focuses on patients' mentalizing difficulties before, during and at the end of therapy. Mentalizing is assessed using different methods. Our main research questions are:

1. 1.To what degree does patients' level of RF change during MBT?
2. 2.Is there a relationship between RF and outcome of MBT?
3. 3.What is the relationship between RF and therapy processes in MBT?
4. 4.Is it possible to identify in-session processes that promote mentalizing?
5. 5.What is the clinical utility of various methods of RF assessment?

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (17)

• Work and Social Adjustments Scale, WSAS, change during treatment and 3 months follow-up

  Work and social adaption

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Global Assessment of Functioning, GAF, change during treatment and 3 months follow-up

  psychosocial functioning

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Patient Health Questionnaire, PHQ-9, change during treatment and 3 months follow-up

  depression

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Patient Health Questionnaire, GAD-7, change during treatment and 3 months follow-up

  anxiety

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Self-harm, self-report, change during treatment and 3 months follow-up

  Self-harm

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Suicide attempts, self-report, change during treatment and 3 months follow-up

  Suicide attempts

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Circumplex of Interpersonal Problems, CIP, change during treatment and 3 months follow-up

  interpersonal problems

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Severity Index of Personality Problems, SIPP-118, change during treatment and 3 months follow-up

  personality functioning

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Level of Personality Functioning Scale, LPFS BF, change during treatment and 3 months follow-up

  personality functioning

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Difficulties in Emotion Regulation Scale, DERS, change during treatment and 3 months follow-up

  emotional regulation

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Toronto Alexithymia Scale, TAS-20, change during treatment and 3 months follow-up

  alexithymia

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Reflective functioning based on AAI, change from baseline to 3 months follow-up

  reflective functioning

  3 months follow-up

• Reflective functioning based on the mentalization breakdown interview, change during treatment and 3 months follow-up

  reflective functioning

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Reflective functioning based on therapy sessions, change during treatment

  reflective functioning

  6, 12, 18, 24, 30 and 36 months

• Months in work or studies, self report, change during treatment and 3 months follow-up

  work functioning

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Experiences in Close relationships, ECR, change during treatment and 3 months follow-up

  attachment

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Suicide ideation, change during treatment and 3 months follow-up

  Suicide ideation

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

Secondary Outcomes (7)

• Substance use (from AUDIT and DUDIT), change during treatment and 3 months follow-up

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• EuroQoL, EQ-5D, change during treatment and 3 months follow-up

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Modified Overt Aggression Scale (selected items), change during treatment and 3 months follow

  6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

• Working Alliance Inventory, WAI, change during treatment

  6, 12, 18, 24, 30 and 36 months

• Group Questionnaire, GQ, change during treatment

  6, 12, 18, 24, 30 and 36 months

Study Arms (1)

Patients with borderline personality disorder

Patients with borderline personality disorder included in the MBT program

Behavioral: Mentalization based therapy

Interventions

Mentalization based therapy BEHAVIORAL

Mentalization based therapy is a specialized treatment for patients with borderline personality disorder. The treatment program combines individual and group therapy, as well as psychoeducation

Patients with borderline personality disorder

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with borderline personality disorder or significant borderline traits, who are treated in the MBT program at the Personality Outpatient Unit, Oslo University Hospital (OUH).

You may qualify if:

• \- Borderline personality disorder or significant borderline traits

You may not qualify if:

• patients with psychotic disorders as their main problem
• Asperger's syndrome/autism spectrum disorders
• low IQ
• unregulated bipolar I disorders as their main problem

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Personality Outpatient Unit, Section of Personality Psychiatry, Clinic for Mental Health and Addiction, Oslo University Hospital

Oslo, 4959 Nydalen, Norway

RECRUITING

Related Publications (1)

• Ulvestad DA, Johansen MS, Kvarstein EH, Pedersen G, Wilberg T. Minding mentalizing - convergent validity of the Mentalization Breakdown Interview. Front Psychiatry. 2024 Jun 21;15:1380532. doi: 10.3389/fpsyt.2024.1380532. eCollection 2024.

  PMID: 38974920 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Theresa Wilberg, professor

  Department of Research and Development, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Wilberg, MD PhD

CONTACT

+47 22923433; uxthwi@ous-hf.no

Elfrida Hartveit Kvarstein, MD PhD

CONTACT

+47 23016940; e.h.kvarstein@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior consultant and professor

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 8, 2019
• Study Start: November 1, 2019
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)