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NCT04157907
Reflective Functioning and Psychotherapy Processes in MBT
trial testing Mentalization based therapy in Borderline Personality Disorder in 60 participants. Status unknown.
28 February 2025
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 1 November 2019 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Mentalization based therapy
Conditions studied
- Borderline Personality Disorder — all drugs for Borderline Personality Disorder →
Sponsor
Oslo University Hospital
Who can join
Adults 18 to 40, any sex, with Borderline Personality Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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?
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Minding mentalizing - convergent validity of the Mentalization Breakdown Interview.
Ulvestad DA, Johansen MS, Kvarstein EH, Pedersen G, et al · · 2024 · PMID 38974920 · DOI 10.3389/fpsyt.2024.1380532
Verify or expand the search:
- PubMed search for NCT04157907
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157907 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 8 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157907.
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