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Reflective Functioning and Psychotherapy Processes in MBT

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ClinicalTrials.gov Identifier: NCT04157907
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Theresa Wilberg, Oslo University Hospital

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

Condition or disease Intervention/treatment
Borderline Personality Disorder Behavioral: Mentalization based therapy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reflective Functioning and Psychotherapy Processes in Mentalization Based Therapy
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with borderline personality disorder
Patients with borderline personality disorder included in the MBT program
Behavioral: Mentalization based therapy
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




Primary Outcome Measures :
  1. Work and Social Adjustments Scale, WSAS, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    Work and social adaption

  2. Global Assessment of Functioning, GAF, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    psychosocial functioning

  3. Patient Health Questionnaire, PHQ-9, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    depression

  4. Patient Health Questionnaire, GAD-7, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    anxiety

  5. Self-harm, self-report, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    Self-harm

  6. Suicide attempts, self-report, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    Suicide attempts

  7. Circumplex of Interpersonal Problems, CIP, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    interpersonal problems

  8. Severity Index of Personality Problems, SIPP-118, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    personality functioning

  9. Level of Personality Functioning Scale, LPFS BF, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    personality functioning

  10. Difficulties in Emotion Regulation Scale, DERS, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    emotional regulation

  11. Toronto Alexithymia Scale, TAS-20, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    alexithymia

  12. Reflective functioning based on AAI, change from baseline to 3 months follow-up [ Time Frame: 3 months follow-up ]
    reflective functioning

  13. Reflective functioning based on the mentalization breakdown interview, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    reflective functioning

  14. Reflective functioning based on therapy sessions, change during treatment [ Time Frame: 6, 12, 18, 24, 30 and 36 months ]
    reflective functioning

  15. Months in work or studies, self report, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    work functioning

  16. Experiences in Close relationships, ECR, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    attachment

  17. Suicide ideation, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    Suicide ideation


Secondary Outcome Measures :
  1. Substance use (from AUDIT and DUDIT), change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    substance use

  2. EuroQoL, EQ-5D, change during treatment and 3 months follow-up [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    quality of life

  3. Modified Overt Aggression Scale (selected items), change during treatment and 3 months follow [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    aggression

  4. Working Alliance Inventory, WAI, change during treatment [ Time Frame: 6, 12, 18, 24, 30 and 36 months ]
    therapeutic alliance

  5. Group Questionnaire, GQ, change during treatment [ Time Frame: 6, 12, 18, 24, 30 and 36 months ]
    alliance in group therapy

  6. Client Satisfaction Scale, CSS, change during treatment and 3 months follow [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    treatment satisfaction

  7. Health service use / NAV contacts and support, change during treatment and 3 months follow [ Time Frame: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up ]
    Health services, social support and benefits



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion Criteria:

- Borderline personality disorder or significant borderline traits

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157907


Contacts
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Contact: Theresa Wilberg, MD PhD +47 22923433 uxthwi@ous-hf.no
Contact: Elfrida Hartveit Kvarstein, MD PhD +47 23016940 e.h.kvarstein@medisin.uio.no

Locations
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Norway
Personality Outpatient Unit, Section of Personality Psychiatry, Clinic for Mental Health and Addiction, Oslo University Hospital Recruiting
Oslo, Norway, 4959 Nydalen
Contact: Theresa Wilberg, MD PhD    +47 22923433    uxthwi@ous-hf.no   
Contact: Elfrida Hartveit Kvarstein, MD PhD    +47 23016940    e.h.kvarstein@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Theresa Wilberg, professor Department of Research and Development, Oslo University Hospital

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Responsible Party: Theresa Wilberg, senior consultant and professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04157907     History of Changes
Other Study ID Numbers: 2018/0519
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders