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Published in: Trials 1/2019

Open Access 01-12-2019 | Psychotherapy | Study protocol

Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial

Authors: Sophie Juul, Susanne Lunn, Stig Poulsen, Per Sørensen, Mehrak Salimi, Janus Christian Jakobsen, Anthony Bateman, Sebastian Simonsen

Published in: Trials | Issue 1/2019

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Abstract

Background

Psychotherapy 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/design

This 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.

Discussion

This 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 registration

ClinicalTrials.gov, NCT03677037. Registered on September 19, 2018.
Appendix
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Literature
1.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5®). Arlington: American Psychiatric Pub; 2013.
2.
Togersen J. In: Oldham J, Skodol AE, Bender DS, editors. Prevalence, Sociodemographics, and Functional Impairment, in Textbook of personality disorders. Washington DC: American Psychiatric Publishing; 2014. p. 109–31.
3.
Fossati A, et al. Patterns of covariation of DSM-IV personality disorders in a mixed psychiatric sample. Compr Psychiatry. 2000;41(3):206–15.PubMedCrossRef
4.
Zimmerman M, Rothschild L, Chelminski I. The prevalence of DSM-IV personality disorders in psychiatric outpatients. Am J Psychiatr. 2005;162(10):1911–8.PubMedCrossRef
5.
Korzekwa MI, et al. Estimating the prevalence of borderline personality disorder in psychiatric outpatients using a two-phase procedure. Compr Psychiatry. 2008;49(4):380–6.PubMedCrossRef
6.
Conklin CZ, Westen D. Borderline Personality Disorder in Clinical Practice. Am J Psychiatr. 2005;162:867–75.CrossRef
7.
Zanarini MC, et al. Axis I comorbidity of borderline personality disorder. Am J Psychiatr. 1998;155:1733–9.PubMedCrossRef
8.
Trull TJ, et al. Borderline personality disorder and substance use disorders A review and integration. Clin Psychol Rev. 2000;20(2):235–53.PubMedCrossRef
9.
Barrachina J, et al. Axis II comorbidity in borderline personality disorder is influenced by sex, age, and clinical severity. Compr Psychiatry. 2011;52(6):725–30.PubMedCrossRef
10.
Lieb K, et al. Pharmacotherapy for borderline personality disorder: Cochrane systematic review of randomised trials. Br J Psychiatry. 2010;196(1):4–12.PubMedCrossRef
11.
Bateman AW, Gunderson J, Mulder R. Treatment of personality disorder. Lancet. 2015;385(9969):735–43.PubMedCrossRef
12.
Cristea IA, et al. Efficacy of Psychotherapies for Borderline Personality Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017;74(4):319–28.PubMedCrossRef
13.
Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatr. 2009;166(12):1355–64.PubMedCrossRef
14.
Bateman A, Fonagy P. Mentalization-based treatment for personality disorders: a practical guide. Oxford: Oxford University Press; 2016.
15.
Karterud S. Mentalization-Based Group Therapy (MBT-G): A theoretical, clinical, and research manual. Oxford: OUP Oxford; 2015.
16.
17.
Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1–27.PubMedCrossRef
18.
Kvarstein EH, et al. Changing from a traditional psychodynamic treatment programme to mentalization-based treatment for patients with borderline personality disorder--does it make a difference? Psychol Psychother. 2015;88(1):71–86.PubMedCrossRef
19.
Bales D, et al. Treatment outcome of 18-month, day hospital mentalization-based treatment (MBT) in patients with severe borderline personality disorder in the netherlands. J Personal Disord. 2012;26(4):568–82.CrossRef
20.
Jorgensen CR, et al. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013;127(4):305–17.PubMedCrossRef
21.
Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatr. 1999;156(10):1563–9.PubMedCrossRef
22.
Laurenssen EM, Luyten P, Kikkert MJ, Westra D, Peen J, Soons MB, Dekker JJ. Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial. Psychol Med. 2018;48(15):2522–29
23.
Bateman A, Fonagy P. 8-year follow-up of patients treated for borderline personality disorder: mentalization-based treatment versus treatment as usual. Am J Psychiatr. 2008;165(5):631–8.PubMedCrossRef
24.
Gratz KL, Tull MT, Levy R. Randomized controlled trial and uncontrolled 9-month follow-up of an adjunctive emotion regulation group therapy for deliberate self-harm among women with borderline personality disorder. Psychol Med. 2014;44(10):2099–112.PubMedCrossRef
25.
Blum N, St. John D, Pfohl B, Stuart S, McCormick B, Allen J, Arndt S, Black DW. Systems Training for Emotional Predictability and Problem Solving (STEPPS) for Outpatients With Borderline Personality Disorder: A Randomized Controlled Trial and 1-Year Follow-Up. Am J Psychiatr. 2008;165:468–78.PubMedCrossRef
26.
Bos EH, van Wel EB, Appelo MT, Verbraak MJ. A randomized controlled trial of a Dutch version of systems training for emotional predictability and problem solving for borderline personality disorder. J Nerv Ment Dis. 2010;198(4):299–304.PubMedCrossRef
27.
McMain SF, et al. A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. Acta Psychiatr Scand. 2017;135(2):138–48.PubMedCrossRef
28.
McMain SF. Advances in the Treatment of Borderline Personality Disorder: An Introduction to the Special Issue. J Clin Psychol. 2015;71(8):741–6.PubMedCrossRef
29.
Knekt P, et al. Randomized trial on the effectiveness of long-and short-term psychodynamic psychotherapy and solution-focused therapy on psychiatric symptoms during a 3-year follow-up. Psychol Med. 2008;38(5):689–703.PubMedCrossRef
30.
Lorentzen S, et al. Comparison of short- and long-term dynamic group psychotherapy: randomised clinical trial. Br J Psychiatry. 2013;203(3):280–7.PubMedCrossRef
31.
Boutron I, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309.PubMedCrossRef
32.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol. 2001;1:2.PubMedPubMedCentralCrossRef
33.
34.
Simonsen S, Heinskou T, Sørensen P, Folke S, Lau ME. Personality disorders: patient characteristics and level of outpatient treatment service. Nord J Psychiatry. 2017;71(5):325–31.
35.
Clifton A, Pilkonis PA. Evidence for a single latent class of Diagnostic and Statistical Manual of Mental Disorders borderline personality pathology. Compr Psychiatry. 2007;48(1):70–8.PubMedCrossRef
36.
Tyrer P, Reed GM, Crawford MJ. Classification, assessment, prevalence, and effect of personality disorder. Lancet. 2015;385(9969):717–26.PubMedCrossRef
37.
Beck E, et al. Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial. Trials. 2016;17(1):314.PubMedPubMedCentralCrossRef
38.
Zanarini. Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): a continuous measure of DSM-IV borderline psychopathology. J Personal Disord. 2003;17(3):233–42.CrossRef
39.
National Insitute for Health and Care Excellence (NICE). Borderline Personality Disorder: the NICE Guideline on Treatment and Management. Br Psychol Soc R Coll Psychiatrists. 2009.
40.
Karterud S, Bateman A. Manual for mentaliseringsbasert psykoedukativ gruppeterapi (MBT-I). Oslo: Gyldendal akademisk; 2011.
41.
Sundhedsstyrelsen, National klinisk retningslinje for behandling af emotionel ustabil personlighedsstruktur, borderline type. 2015.
42.
Lecrubier Y, et al. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997;12:224–31.CrossRef
43.
First MB, et al. The Structured Clinical Interview for DSM-II-R Personality Disorders (SCID-II). Part II: Multi-site test-retest reliability study. J Personal Disord. 1995;9(2):92–104.CrossRef
44.
Lobbestael J, Leurgans M, Arntz A. Inter-rater reliability of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID I) and Axis II Disorders (SCID II). Clin Psychol Psychother. 2011;18(1):75–9.PubMedCrossRef
45.
Cicchetti DV. Guidelines, Criteria, an Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology. Psychol Assess. 1994;6(4):284–90.CrossRef
46.
Pedersen G, Kvarstein EH, Wilberg T. The Work and Social Adjustment Scale: Psychometric properties and validity among males and females, and outpatients with and without personality disorders. Personal Ment Health. 2017;11(4):215–28.PubMedCrossRef
47.
Miles HH, Barrabee EL, Finesinger JE. Evaluation of psychotherapy: with a follow up study of 62 cases of anxiety neurosis. Psychosom Med. 1951 Mar-Apr;13(2):83-105.
48.
Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual Framework and Item Selection. Med Care. 1992;30(6):473–83.PubMedCrossRef
49.
Jones SH, et al. Reliability and Validity of the Global Assessment of Functioning (GAF). Br J Psychiatry. 1995;166:654–9.PubMedCrossRef
50.
Derogatis LR, Cleary PA. Confirmation of the dimensional structure of the SCL-90: a study in construct validation. J Clin Psychol. 1977;33(4):981–9.CrossRef
51.
Hutsebaut J, Feensta D, Kamphuis J. Development and Preliminary Psychometric Evaluation of a Brief Self-Report Questionnaire for the Assessment of the DSM–5 Level of Personality Functioning Scale: The LPFS Brief Form (LPFS-BF). Personal Disord Theory Res Treat. 2016;7(2):192–4.CrossRef
52.
Bartholomew K, Horowitz LM. Attachment Styles Among Young Adults: A Test of a Four-Category Model. J Pers Soc Psychol. 1991;61(2):226–44.PubMedCrossRef
53.
Zanarini, et al. Development of the self-report version of the Zanarini Rating Scale for Borderline Personality Disorder. Personal Ment Health. 2015;9(4):243–9.PubMedPubMedCentralCrossRef
54.
Krogel J, et al. The Group Questionnaire: a clinical and empirically derived measure of group relationship. Psychother Res. 2013;23(3):344–54.PubMedCrossRef
55.
Hausberg M, Schulz H, Piegler T, Happach C, Klöpper M, Brütt A, et al. Is a self-rated instrument appropriate to assess mentalization in patients with mental disorders? Development and first validation of the Mentalization Questionnaire (MZQ). Psychother Res. 2012;22(6):699–709.PubMedCrossRef
56.
Gotzsche PC. Blinding during data analysis and writing of manuscripts. Control Clin Trials. 1996;17(4):285–90 discussion 290-3.PubMedCrossRef
57.
Jarvinen TL, et al. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014;67(7):769–72.PubMedCrossRef
58.
Priebe S, et al. Effectiveness and cost-effectiveness of dialectical behaviour therapy for self-harming patients with personality disorder: a pragmatic randomised controlled trial. Psychother Psychosom. 2012;81(6):356–65.PubMedCrossRef
59.
Jakobsen JC, et al. The thresholds for statistical and clinical significance - a five-step procedure for evaluation of intervention effects in randomised clinical trials. BMC Med Res Methodol. 2014;14:34.PubMedPubMedCentralCrossRef
60.
Jakobsen JC, et al. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.PubMedPubMedCentralCrossRef
61.
Englev E, Petersen KP. ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives. Dan Med J. 2003;165(16):1659–62.
Metadata
Title
Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial
Authors
Sophie Juul
Susanne Lunn
Stig Poulsen
Per Sørensen
Mehrak Salimi
Janus Christian Jakobsen
Anthony Bateman
Sebastian Simonsen
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3306-7

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