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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Borderline Personality Disorder | Study protocol

The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial

Authors: Melissa G. A. Remeeus, Sharon L. Clarke, Dine J. Feenstra, Hester Van Eeren, Maaike L. Smits, Sara Debruyne, Mirjam E. J. Kouijzer, Patrick Luyten, Ron H. J. Scholte, Joost Hutsebaut

Published in: Trials | Issue 1/2024

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Abstract

Background

Although clinical guidelines prioritize the treatment of depression and anxiety in young persons, there is accumulating evidence that the presence of symptoms of borderline personality disorder (BPD) is associated with the limited effectiveness of these standard treatments. These findings stress the need for interventions addressing early-stage BPD in young people with presenting symptoms of anxiety and depressive disorders. The aim of this study is to investigate the (cost-)effectiveness of an early intervention programme for BPD (MBT-early) compared to first-choice psychological treatment for depression and anxiety according to Dutch treatment guidelines (CBT), in adolescents with either depression, anxiety, or both, in combination with early-stage BPD.

Methods

This study is a multi-centre randomized controlled trial. A total of 132 adolescents, presenting with either depression, anxiety, or both and significant BPD features will be randomized to either MBT-early or CBT. The severity of BPD, symptoms of depression and anxiety, personality, social and academic functioning, and quality of life will be assessed at baseline, end of treatment, and at 12-, 18-, and 24-month follow-up, along with medical costs and costs of productivity losses for cost-effectiveness analyses.

Discussion

This study will provide an empirical evaluation of the potential surplus value of early intervention in young people for whom treatment oriented at common mental disorders like anxiety and depression may be insufficient given their underlying personality problems.

Trial registration

Netherlands Trial Register, NL9569. Registered on June 15, 2021.
Literature
1.
Fok ML, Hayes RD, Chang CK, Stewart R, Callard FJ, Moran P. Life expectancy at birth and all-cause mortality among people with personality disorder. J Psychosom Res. 2012;73(2):104–7.PubMedCrossRef
2.
Grant BF, Chou SP, Goldstein RB, Huang B, Stinson FS, Saha TD, et al. Prevalence, correlates, disability, and comorbidity of DSM-IV borderline personality disorder: results from the Wave 2 National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2008;69(4):533–45.PubMedPubMedCentralCrossRef
3.
Moran P, Stewart R, Brugha T, Bebbington P, Bhugra D, Jenkins R, et al. Personality disorder and cardiovascular disease: results from a national household survey. J Clin Psychiatry. 2007;68(1):69–74.PubMedCrossRef
4.
Wright AG, Zalewski M, Hallquist MN, Hipwell AE, Stepp SD. Developmental trajectories of borderline personality disorder symptoms and psychosocial functioning in adolescence. J Pers Disord. 2016;30(3):351–72.PubMedCrossRef
5.
Zanarini MC, Frankenburg FR, Reich DB, Fitzmaurice G. Attainment and stability of sustained symptomatic remission and recovery among patients with borderline personality disorder and axis II comparison subjects: a 16-year prospective follow-up study. Am J Psychiatry. 2012;169(5):476–83.PubMedPubMedCentralCrossRef
6.
Hastrup LH, Kongerslev MT, Simonsen E. Low vocational outcome among people diagnosed with borderline personality disorder during first admission to mental health services in Denmark: a nationwide 9-year register-based study. J Pers Disord. 2019;33(3):326–40.PubMedCrossRef
7.
Soeteman DI, Verheul R, Busschbach JJ. The burden of disease in personality disorders: diagnosis-specific quality of life. J Pers Disord. 2008;22(3):259–68.PubMedCrossRef
8.
Soeteman DI, Hakkaart-van Roijen L, Verheul R, Busschbach JJ. The economic burden of personality disorders in mental health care. J Clin Psychiatry. 2008;69(2):259–65.PubMedCrossRef
9.
Chanen AM, McCutcheon LK, Germano D, Nistico H, Jackson HJ, McGorry PD. The HYPE Clinic: an early intervention service for borderline personality disorder. J Psychiatr Pract. 2009;15(3):163–72.PubMedCrossRef
10.
Hutsebaut J, Videler AC, Verheul R, Van Alphen SPJ. Managing borderline personality disorder from a life course perspective: clinical staging and health management. Personal Disord. 2019;10(4):309–16.PubMedCrossRef
11.
Hastrup LH, Jennum P, Ibsen R, Kjellberg J, Simonsen E. Welfare consequences of early-onset borderline personality disorder: a nationwide register-based case-control study. Eur Child Adolesc Psychiatry. 2022;31(2):253–60.PubMedCrossRef
12.
Wertz J, Caspi A, Ambler A, Arseneault L, Belsky DW, Danese A, et al. Borderline symptoms at age 12 signal risk for poor outcomes during the transition to adulthood: findings from a genetically sensitive longitudinal cohort study. J Am Acad Child Adolesc Psychiatry. 2020;59(10):1165-77 e2.PubMedPubMedCentralCrossRef
13.
Hutsebaut J, Clarke SL, Chanen AM. The diagnosis that should speak its name: why it is ethically right to diagnose and treat personality disorder during adolescence. Front Psychiatry. 2023;14:1130417.PubMedPubMedCentralCrossRef
14.
Laurenssen EMP, Hutsebaut J, Feenstra DJ, Van Busschbach JJ, Luyten P. Diagnosis of personality disorders in adolescents: a study among psychologists. Child Adolesc Psychiatry Ment Health. 2013;7(1):3.PubMedPubMedCentralCrossRef
15.
O’Dwyer N, Rickwood D, Buckmaster D, Watsford C. Therapeutic interventions in Australian primary care, youth mental health settings for young people with borderline personality disorder or borderline traits. Borderline Personality Disord Emot Dysregul. 2020;7(1):23.CrossRef
16.
Kiviruusu O, Strandholm T, Karlsson L, Marttunen M. Outcome of depressive mood disorder among adolescent outpatients in an eight-year follow-up. J Affect Disord. 2020;266:520–7.PubMedCrossRef
17.
Jørgensen MS, Storebø OJ, Stoffers-Winterling JM, Faltinsen E, Todorovac A, Simonsen E. Psychological therapies for adolescents with borderline personality disorder (BPD) or BPD features—a systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis. PLoS One. 2021;16(1):e0245331.PubMedPubMedCentralCrossRef
18.
Li ET, Midgley N, Luyten P, Sprecher EA, Campbell C. Mapping the journey from epistemic mistrust in depressed adolescents receiving psychotherapy. J Couns Psychol. 2022;69(5):678–90.PubMedCrossRef
19.
Miller AL, Rathus JH, Linehan MM. Dialectical behavior therapy with suicidal adolescents. New York (NY): Guilford Press; 2006.
20.
Bleiberg E, Rossouw T, Fonagy P. Adolescent breakdown and emerging borderline personality disorder. 2012.
21.
Foelsch PA, Schlüter-Müller S, Odom AE, Arena HT, Borzutzky A, Schmeck K. Adolescent identity treatment: an integrative approach for personality pathology. Heidelberg (DE): Springer International Publishing; 2014.CrossRef
22.
Beck E, Bo S, Jorgensen MS, Gondan M, Poulsen S, Storebo OJ, et al. Mentalization-based treatment in groups for adolescents with borderline personality disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2020;61(5):594–604.PubMedCrossRef
23.
Chanen AM, Jackson HJ, McCutcheon LK, Jovev M, Dudgeon P, Yuen HP, et al. Early intervention for adolescents with borderline personality disorder: quasi-experimental comparison with treatment as usual. Aust N Z J Psychiatry. 2009;43(5):397–408.PubMedCrossRef
24.
Gleeson JF, Chanen A, Cotton SM, Pearce T, Newman B, McCutcheon L. Treating co-occurring first-episode psychosis and borderline personality: a pilot randomized controlled trial. Early Interv Psychiatry. 2012;6(1):21–9.PubMedCrossRef
25.
McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, et al. Efficacy of dialectical behavior therapy for adolescents at high risk for suicide: a randomized clinical trial. JAMA Psychiat. 2018;75(8):777–85.CrossRef
26.
Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, et al. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014;53(10):1082–91.PubMedCrossRef
27.
Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012;51(12):1304-13 e3.PubMedCrossRef
28.
Salzer S, Cropp C, Jaeger U, Masuhr O, Streeck-Fischer A. Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial. Psychol Med. 2014;44(10):2213–22.PubMedCrossRef
29.
Santisteban DA, Mena MP, Muir J, McCabe BE, Abalo C, Cummings AM. The efficacy of two adolescent substance abuse treatments and the impact of comorbid depression: results of a small randomized controlled trial. Psychiatr Rehabil J. 2015;38(1):55–64.PubMedPubMedCentralCrossRef
30.
Schuppert HM, Timmerman ME, Bloo J, van Gemert TG, Wiersema HM, Minderaa RB, et al. Emotion regulation training for adolescents with borderline personality disorder traits: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012;51(12):1314-23 e2.PubMedCrossRef
31.
Schuppert HM, Giesen-Bloo J, van Gemert TG, Wiersema HM, Minderaa RB, Emmelkamp PM, et al. Effectiveness of an emotion regulation group training for adolescents—a randomized controlled pilot study. Clin Psychol Psychother. 2009;16(6):467–78.PubMedCrossRef
32.
Hutsebaut J, Debbané M, Sharp C. Designing a range of mentalizing interventions for young people using a clinical staging approach to borderline pathology. Borderline Personal Disord Emot Dysregul. 2020;7(1):1–10.
33.
Chanen AM, Berk M, Thompson K. Integrating early intervention for borderline personality disorder and mood disorders. Harv Rev Psychiatry. 2016;24(5):330–41.PubMedCrossRef
34.
McGorry PD, Mei C. Clinical staging for youth mental disorders: progress in reforming diagnosis and clinical care. Annu Rev Dev Psychology. 2021;3(1):15–39.CrossRef
35.
Arntz A, Kamphuis JH, Derks JL. SCID-5-S: Gestructureerd klinisch interview voor DSM-5 Syndroomstoornissen. Amsterdam: Boom; 2018. p. 454.
36.
Arntz A, Kamphuis JH, Derks JL. SCID-5-P: Gestructureerd klinisch interview voor DSM-5 persoonlijkheidsstoornissen. Amsterdam: Boom; 2017. p. 120.
37.
Landelijke Stuurgroep Multidisciplinaire Richtlijnontwikkeling in de GGZ. Multidisciplinaire richtlijn persoonlijkheidsstoornissen. Utrecht: Trimbos-Instituut; 2008.
38.
Davidson KM. Cognitive therapy for personality disorders: a guide for therapists. Oxford; Boston: Butterworth-Heinemann; 2000.
39.
Braet C, Bögels SM. Protocollaire behandelingen voor kinderen en adolescenten met psychische klachten. Amsterdam: Boom; 2020.
40.
Stoffers-Winterling JM, Storebø OJ, Kongerslev MT, Faltinsen E, Todorovac A, Sedoc Jørgensen M, et al. Psychotherapies for borderline personality disorder: a focused systematic review and meta-analysis. Br J Psychiatry. 2022;221(3):538–52.PubMedCrossRef
41.
Hajek Gross C, Oehlke S-M, Prillinger K, Goreis A, Plener PL, Kothgassner OD. Efficacy of mentalization-based therapy in treating self-harm: a systematic review and meta-analysis. Suicide Life-Threat Behav. 2024;00:1–21.
42.
Byrne G, Murphy S, Connon G. Mentalization-based treatments with children and families: a systematic review of the literature. Clin Child Psychol Psychiatry. 2020;25(4):1022–48.PubMedCrossRef
43.
Hutsebaut J, Feenstra D, Keur E, Schäfer B, Bales D. Tijdig herkennen en behandelen van borderlineproblematiek bij jongeren met MBT-early. Tijdschr Psychother. 2017;43(5):330–44.CrossRef
44.
Luyten P, Campbell C, Allison E, Fonagy P. The mentalizing approach to psychopathology: state of the art and future directions. Annu Rev Clin Psychol. 2020;16(1):297–325.PubMedCrossRef
45.
Bateman A, Fonagy P. Psychotherapy for borderline personality disorder: mentalization-based treatment. New York (NY): Oxford University Press; 2004.CrossRef
46.
Schuppert HM, Bloo J, Minderaa RB, Emmelkamp PM, Nauta MH. Psychometric evaluation of the Borderline Personality Disorder Severity Index-IV–adolescent version and parent version. J Pers Disord. 2012;26(4):628–40.PubMedCrossRef
47.
48.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.PubMedCrossRef
49.
50.
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–77.PubMedPubMedCentralCrossRef
51.
De Beurs E. Brief Symptom Inventory 18-BSI 18-Handleiding herziene editie. Leiden: PITS BV; 2011.
52.
Verhulst F, Van der Ende J. Handleiding ASEBA-Vragenlijsten voor leeftijden 6 t/m 18 jaar: CBCL/6–18. Rotterdam: YSR en TRF, ASEBA; 2013.
53.
Weekers LC, Hutsebaut J, Kamphuis JH. The level of Personality Functioning Scale-Brief Form 2.0: update of a brief instrument for assessing level of personality functioning. Personal Ment Health. 2019;13(1):3–14.PubMedCrossRef
54.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. Washington (DC): American Psychiatric Association Publishing; 2013.CrossRef
55.
Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, et al. Development and validation of a self-report measure of mentalizing: the Reflective Functioning Questionnaire. PLoS One. 2016;11(7):e0158678.PubMedPubMedCentralCrossRef
56.
Üstün TB, Kostanjsek N, Chatterji S, Rehm J. Measuring health and disability: manual for WHO Disability Assessment Schedule (WHODAS 2.0). Geneva: World Health Organization; 2010. p. vii + 84.
57.
Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, et al. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents’ well-being and health-related quality of life. Qual Life Res. 2010;19(10):1487–500.PubMedPubMedCentralCrossRef
58.
Versteegh MM, Vermeulen KM, Evers SM, de Wit GA, Prenger R, Stolk EA. Dutch tariff for the five-level version of EQ-5D. Value in health. 2016;19(4):343–52.CrossRef
59.
Van Aken M, Hessels C. Nederlandse vertaling van de Network of Relationships Inventory—Behavioral System Version. Utrecht: Ontwikkelingspsychologie, Universiteit Utrecht; 2012.
60.
iMTA Productivity and Health Research Group. Handleiding iMTA Productivity Cost Questionnaire (iPCQ). Rotterdam: iMTA, Erasmus Universiteit; 2018.
61.
Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13(1):217.PubMedPubMedCentralCrossRef
62.
Hoefman R, Van Exel N, Brouwer W. iMTA Valuation of Informal Care Questionnaire (iVICQ). Version 1.0 (December 2011). Rotterdam: IBMG/iMTA; 2011. 2013.
63.
Brooks R, Rabin R, De Charro F. The measurement and valuation of health status using EQ-5D: a European perspective: evidence from the EuroQol BIOMED Research Programme. Dordrecht (NL): Springer Science & Business Media; 2013.
64.
Laurenssen EM, Hutsebaut J, Feenstra DJ, Bales DL, Noom MJ, Busschbach JJ, et al. Feasibility of mentalization-based treatment for adolescents with borderline symptoms: a pilot study. Psychotherapy (Chic). 2014;51(1):159–66.PubMedCrossRef
65.
Bales DL, Timman R, Andrea H, Busschbach JJ, Verheul R, Kamphuis JH. Effectiveness of day hospital mentalization-based treatment for patients with severe borderline personality disorder: a matched control study. Clin Psychol Psychother. 2015;22(5):409–17.PubMedCrossRef
66.
Smits ML, Feenstra DJ, Eeren HV, Bales DL, Laurenssen EMP, Blankers M, et al. Day hospital versus intensive out-patient mentalisation-based treatment for borderline personality disorder: multicentre randomised clinical trial. Br J Psychiatry. 2020;216(2):79–84.PubMedCrossRef
67.
Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, et al. Cost-effectiveness analysis alongside clinical trials II-an ISPOR Good Research Practices Task Force report. Value Health. 2015;18(2):161–72.PubMedCrossRef
68.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)–explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013;16(2):231–50.PubMedCrossRef
69.
Zorginstituut Nederland. Richtlijnen voor het uitvoeren van economische evaluaties in de gezondheidszorg. Diemen: Zorginstituut Nederland; 2016.
70.
Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio I, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194–220.PubMedCrossRef
71.
Metadata
Title
The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
Authors
Melissa G. A. Remeeus
Sharon L. Clarke
Dine J. Feenstra
Hester Van Eeren
Maaike L. Smits
Sara Debruyne
Mirjam E. J. Kouijzer
Patrick Luyten
Ron H. J. Scholte
Joost Hutsebaut
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08095-9

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