Dataset Information

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT).

ABSTRACT:

Introduction

Borderline personality disorder (BPD) is a severe and prevalent psychiatric disorder. Mentalization-based therapy (MBT) is an evidence-based intervention for BPD, and several countries offer treatment programs for BPD lasting for years, which is resource demanding. No previous trial has compared short-term with long-term MBT.

Objective

The aim of the study was to assess the efficacy and safety of short-term versus long-term MBT for outpatients with BPD.

Methods

Adult outpatients (≥18 years) with subthreshold or diagnosed BPD were randomly assigned (1:1) to short-term MBT (5 months) or long-term MBT (14 months). The primary outcome was BPD symptoms assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes were functional impairment, quality of life, global functioning, and severe self-harm. All outcomes were primarily assessed at 16 months after randomization. This trial was prospectively registered at ClinicalTrials.gov, NCT03677037.

Results

Between October 4, 2018, and December 3, 2020, we randomly assigned 166 participants to short-term MBT (n = 84) or long-term MBT (n = 82). Regression analyses showed no evidence of a difference when assessing BPD symptoms (MD 0.99; 95% CI: -1.06 to 3.03; p = 0.341), level of functioning (MD 1.44; 95% CI: -1.43 to 4.32; p = 0.321), quality of life (MD -0.91; 95% CI: -4.62 to 2.79; p = 0.626), global functioning (MD -2.25; 95% CI: -6.70 to 2.20; p = 0.318), or severe self-harm (RR 1.37; 95% CI: 0.70-2.84; p = 0.335). More participants in the long-term MBT group had a serious adverse event compared with short-term MBT (RR 1.63; 95% CI: 0.94-3.07; p = 0.088), primarily driven by a difference in psychiatric hospitalizations (RR 2.03; 95% CI: 0.99-5.09; p = 0.056).

Conclusion

Long-term MBT did not lead to lower levels of BPD symptoms, nor did it influence any of the secondary outcomes compared with short-term MBT.

SUBMITTER: Juul S

PROVIDER: S-EPMC10716869 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT).

Juul Sophie S Jakobsen Janus Christian JC Hestbaek Emilie E Jørgensen Caroline Kamp CK Olsen Markus Harboe MH Rishede Marie M Frandsen Frederik Weischer FW Bo Sune S Lunn Susanne S Poulsen Stig S Sørensen Per P Bateman Anthony A Simonsen Sebastian S

Psychotherapy and psychosomatics 20231107 5

<h4>Introduction</h4>Borderline personality disorder (BPD) is a severe and prevalent psychiatric disorder. Mentalization-based therapy (MBT) is an evidence-based intervention for BPD, and several countries offer treatment programs for BPD lasting for years, which is resource demanding. No previous trial has compared short-term with long-term MBT.<h4>Objective</h4>The aim of the study was to assess the efficacy and safety of short-term versus long-term MBT for outpatients with BPD.<h4>Methods</h4 ...[more]

PMID: 37935133

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Project description:BackgroundPsychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown.Methods/designThe Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36-mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan.DiscussionWe have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.Trial registrationClinicalTrials.gov NCT03677037 . Registered on 19 September 2018.

Project description:BackgroundPsychotherapy for borderline personality disorder is often lengthy and resource-intensive. However, the current length of outpatient treatments is arbitrary and based on trials that never tested if the treatment intensity could be reduced. As a result, there is insufficient evidence to inform the decision between short-term and long-term psychotherapy for borderline personality disorder. Mentalization-based therapy is one treatment option for borderline personality disorder and consists traditionally of an 18-month treatment program.Methods/designThis trial is an investigator-initiated single-center randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be included if they meet a minimum of four DSM-V criteria for borderline personality disorder. Participants will be assessed before randomization, and at 8, 16, and 24 months after randomization. The primary outcome is severity of borderline symptomatology assessed with the Zanarini Rating Scale for borderline personality disorder. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale, Global Assessment of Functioning) and quality of life (Short-Form Health Survey 36). Severity of psychiatric symptoms (Symptom Checklist 90-R) will be included as an exploratory outcome. Measures of personality functioning, attachment, borderline symptoms, group alliance, and mentalization skills will be included to explore potential predictors and mechanisms of change.DiscussionThis trial will provide evidence of the beneficial and harmful effects of short-term compared to long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.Trial registrationClinicalTrials.gov, NCT03677037 . Registered on September 19, 2018.

Project description:Conduct disorder (CD) is a common psychiatric disorder in youth characterized by persisting norm-violating or aggressive behavior. Considering high individual and societal burden, feasible and effective psychotherapeutic treatment is desirable. Yet, treatments and research in this patient group are scarce. This study investigates the feasibility of mentalization-based treatment for adolescents with CD (MBT-CD) in terms of acceptability of MBT-CD and scientific assessments by participants as well as necessary organizational resources to conduct a consecutive randomized controlled trial (RCT). Recruitment, adherence and treatment session numbers were descriptively analyzed. Treatment evaluation interviews were qualitatively analyzed. A subset of sessions of therapists without prior MBT experience was rated for MBT adherence. Quantitative data were used to plan a consecutive RCT. Pre to post treatment changes in diagnosis and self-reported aggression, mentalizing and personality functioning were preliminarily analyzed. N = 45 adolescents with CD were recruited. 43% dropped out. Acceptance of scientific assessments was somewhat lower than therapy adherence (questionnaires filled out by ~ 80% of adolescents in treatment), and low at follow-up (25% of treatment completers). Mean session number was 30.3. Most treatment completers were satisfied with MBT-CD. Referrals mainly came from child and youth services and psychiatry. Nine of 16 sessions rated for MBT adherence were adherent. A priori sample size estimation for a prospective RCT with a drop-out rate of 43% yielded a sample of N = 158 to detect an effect f = .15 with 80% power in a repeated measures ANOVA. Pre-post analyses revealed diagnostic improvement in 68%. Of self-reported data, empathy pathology improved. Findings provide a sound basis for a consecutive feasibility and pilot RCT. TRIAL REGISTRATION: Clinicaltrials.gov, registration number NCT02988453, November 30, 2016, https://clinicaltrials.gov/ct2/show/NCT02988453.

Dataset Information

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT).

Introduction

Objective

Methods

Results

Conclusion

Publications

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT).

Similar Datasets

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