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Open Access 01-12-2018 | Study protocol

Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): a pragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy

Authors: Marit Kool, Henricus L. Van, Anna Bartak, Saskia C. M. de Maat, Arnoud Arntz, Johanna W. van den Eshof, Jaap Peen, Matthijs Blankers, Judith E. Bosmans, Jack J. M. Dekker

Published in: BMC Psychiatry | Issue 1/2018

Abstract

Background

Patients with comorbid depression and personality disorders suffer from a heavy disease burden while tailored treatment options are limited, accounting for a high psychological and economic burden. Little is known about the effect of treatment dosage and type of psychotherapy for this specific co-morbid patient population, in terms of treatment-effect and cost-effectiveness. This study aims to compare treatment outcome of 25 versus 50 individual therapy sessions in a year. We expect the 50-session condition to be more effective in treating depression and maintaining the effect. Secondary objectives will be addressed in order to find therapy-specific and non-specific mechanisms of change.

Methods

In a mono-center pragmatic randomized controlled trial with a 2 × 2 factorial design, 200 patients with a depressive disorder and personality disorder(s) will be included. Patients will be recruited from a Dutch mental health care institute for personality disorders. They will be randomized over therapy dosage (25 vs 50 sessions in a year) and type of therapy (schema therapy vs short-term psychodynamic supportive psychotherapy). The primary clinical outcome measure will be depression severity and remission. Changes in personality functioning and quality of life will be investigated as secondary outcomes. A priori postulated effect moderators and mediators will be collected as well. All patients are assessed at baseline and at 1, 2, 3, 6, 9–12 months (end of therapy) and at follow up (6 and 12 months after end of treatment). Alongside the trial, an economic evaluation will be conducted. Costs will be collected from a societal perspective.

Discussion

This trial will be the first to compare two psychotherapy dosages in patients with both depression and personality disorders. Insight in the effect of treatment dosage for this patient group will contribute to both higher treatment effectiveness and lower costs. In addition, this study will contribute to the limited evidence base on treating patients with both depression and personality disorders. Understanding the processes that account for the therapeutic changes could help to gain insight in what works for whom.

Trial registration

This trial has been registered on July 20th 2016, Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR5941).

Friborg O, Martinsen EW, Martinussen M, Kaiser S, Overgard KT, Rosenvinge JH. Comorbidity of personality disorders in mood disorders: a meta-analytic review of 122 studies from 1988 to 2010. J Affect Disord. 2014;152–154:1–11. https://doi.org/10.1016/j.jad.2013.08.023.CrossRefPubMed

Skodol AE, Stout RL, McGlashan TH, Grilo CM, Gunderson JG, Shea MT, et al. Co-occurrence of mood and personality disorders: a report from the collaborative longitudinal personality disorders study (CLPS). Depress Anxiety. 1999;10(4):175–82.PubMedCrossRef

Renner F, Bamelis LL, Huibers MJ, Speckens A, Arntz A. The impact of comorbid depression on recovery from personality disorders and improvements in psychosocial functioning: results from a randomized controlled trial. Behav Res Ther. 2014;63:55–62. https://doi.org/10.1016/j.brat.2014.09.006.CrossRefPubMed

Svartberg M, Stiles TC, Seltzer MH. Randomized, controlled trial of the effectiveness of short-term dynamic psychotherapy and cognitive therapy for cluster C personality disorders. Am J Psychiatry. 2004;161(5):810–7.PubMedCrossRef

Howard KI, Kopta SM, Krause MS, Orlinsky DE. The dose-effect relationship in psychotherapy. Am Psychol. 1986;41(2):159–64.PubMedCrossRef

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

Soeteman DI, Verheul R, Busschbach JJ. The burden of disease in personality disorders: diagnosis-specific quality of life. J Personal Disord. 2008;22(3):259–68. https://doi.org/10.1521/pedi.2008.22.3.259.CrossRef

Newton-Howes G, Tyrer P, Johnson T, Mulder R, Kool S, Dekker J, et al. Influence of personality on the outcome of treatment in depression: systematic review and meta-analysis. J Personal Disord. 2014;28(4):577–93. https://doi.org/10.1521/pedi_2013_27_070.CrossRef

Hellerstein DJ, Skodol AE, Petkova E, Xie H, Markowitz JC, Yen S, et al. The impact of comorbid dysthymic disorder on outcome in personality disorders. Compr Psychiatry. 2010;51(5):449–57. https://doi.org/10.1016/j.comppsych.2009.11.002.CrossRefPubMedPubMedCentral

10.

Leichsenring F, Schauenburg H. Empirically supported methods of short-term psychodynamic therapy in depression - towards an evidence-based unified protocol. J Affect Disord. 2014;169:128–43.PubMedCrossRef

11.

Driessen E, Cuijpers P, de Maat SC, Abbass AA, de Jonghe F, Dekker JJ. The efficacy of short-term psychodynamic psychotherapy for depression: a meta-analysis. Clin Psychol Rev. 2010;30(1):25–36. https://doi.org/10.1016/j.cpr.2009.08.010.CrossRefPubMed

12.

Kool S, Schoevers R, de Maat S, Van R, Molenaar P, Vink A, et al. Efficacy of pharmacotherapy in depressed patients with and without personality disorders: a systematic review and meta-analysis. J Affect Disord. 2005;88(3):269–78. https://doi.org/10.1016/j.jad.2005.05.017.CrossRefPubMed

13.

Fonagy P. The effectiveness of psychodynamic psychotherapies: an update. World Psychiatry. 2015;14(2):137–50. https://doi.org/10.1002/wps.20235.CrossRefPubMedPubMedCentral

14.

Connolly Gibbons MB, Gallop R, Thompson D, Luther D, Crits-Christoph K, Jacobs J, et al. Comparative effectiveness of cognitive therapy and dynamic psychotherapy for major depressive disorder in a community mental health setting: a randomized clinical noninferiority trial. JAMA Psychiatry. 2016;73(9):904–11. https://doi.org/10.1001/jamapsychiatry.2016.1720.CrossRefPubMed

15.

Young JE, Klosko JS & Weishaar ME. Schema therapy: a practitioner’s guide. New York: Guilford Press; 2003.

16.

Bamelis LL, Evers SM, Spinhoven P, Arntz A. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders. Am J Psychiatry. 2014;171(3):305–22.PubMedCrossRef

17.

Renner F, Arntz A, Leeuw I, Huibers M. Treatment for chronic depression using schema therapy. Clin Psychol Sci Pract. 2013;20:166–80.CrossRef

18.

Carter JD, McIntosh VV, Jordan J, Porter RJ, Frampton CM, Joyce PR. Psychotherapy for depression: a randomized clinical trial comparing schema therapy and cognitive behavior therapy. J Affect Disord. 2013;151(2):500–5. https://doi.org/10.1016/j.jad.2013.06.034.CrossRefPubMed

19.

Malogiannis IA, Arntz A, Spyropoulou A, Tsartsara E, Aggeli A, Karveli S, et al. Schema therapy for patients with chronic depression: a single case series study. J Behav Ther Exp Psychiatry. 2014;45(3):319–29.PubMedCrossRef

20.

Renner F, Arntz A, Peeters FP, Lobbestael J, Huibers MJ. Schema therapy for chronic depression: results of a multiple single case series. J Behav Ther Exp Psychiatry. 2016;51:66–73. https://doi.org/10.1016/j.jbtep.2015.12.001.CrossRefPubMed

21.

Negt P, Brakemeier EL, Michalak J, Winter L, Bleich S, Kahl KG. The treatment of chronic depression with cognitive behavioral analysis system of psychotherapy: a systematic review and meta-analysis of randomized-controlled clinical trials. Brain Behav. 2016;6(8):e00486. https://doi.org/10.1002/brb3.486.CrossRefPubMedPubMedCentral

22.

Fonagy P, Rost F, Carlyle JA, McPherson S, Thomas R, Pasco Fearon RM, et al. Pragmatic randomized controlled trial of long-term psychoanalytic psychotherapy for treatment-resistant depression: the Tavistock adult depression study (TADS). World Psychiatry. 2015;14(3):312–21. https://doi.org/10.1002/wps.20267.CrossRefPubMedPubMedCentral

23.

Leichsenring F, Rabung S. Long-term psychodynamic psychotherapy in complex mental disorders: update of a meta-analysis. Br J Psychiatry. 2011;199(1):15–22.PubMedCrossRef

24.

Perry JC, Banon E, Ianni F. Effectiveness of psychotherapy for personality disorders. Am J Psychiatry. 1999;156(9):1312–21.PubMedCrossRef

25.

Freedman N, Hoffenberg JD, Vorus N, Frosch A. The effectiveness of psychoanalytic psychotherapy: the role of treatment duration, frequency of sessions, and the therapeutic relationship. J Am Psychoanal Assoc. 1999;47(3):741–72.PubMedCrossRef

26.

Kordy H, von M R, Senf W. Time and its relevance for a successful psychotherapy. Psychother Psychosom. 1988;49(3–4):212–22.PubMedCrossRef

27.

Lambert JJO, B.M. The efficacy and effectiveness of psychotherapy. In: L MJ, editor. Bergin and Gafield’s handbook of psychotherapy and behavior change. New York: Wiley; 2013.

28.

Kool S, Dekker J, Duijsens IJ, de J F, Puite B. Changes in personality pathology after pharmacotherapy and combined therapy for depressed patients. J Personal Disord. 2003;17(1):60–72.CrossRef

29.

Cuijpers P, Huibers M, Ebert DD, Koole SL, Andersson G. How much psychotherapy is needed to treat depression? A metaregression analysis. J Affect Disord. 2013;149(1–3):1–13.PubMedCrossRef

30.

Bruijniks SJ, Bosmans J, Peeters FP, Hollon SD, van O P, van den B M, et al. Frequency and change mechanisms of psychotherapy among depressed patients: study protocol for a multicenter randomized trial comparing twice-weekly versus once-weekly sessions of CBT and IPT. BMC Psychiatry. 2015;15:137.PubMedPubMedCentralCrossRef

31.

Reardon ML, Cukrowicz KC, Reeves MD, Joiner TE. Duration and regularity of therapy attendance as predictors of treatment outcome in an adult outpatient population. Psychother Res. 2002;12(3):273–85.CrossRef

32.

Bartak A, Spreeuwenberg MD, Andrea H, Holleman L, Rijnierse P, Rossum BV, et al. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorders: results of a large prospective multicentre study. Psychother Psychosom. 2010;79(1):20–30.PubMedCrossRef

33.

Soeteman DI, Verheul R, Meerman AM, Ziegler U, Rossum BV, Delimon J, et al. Cost-effectiveness of psychotherapy for cluster C personality disorders: a decision-analytic model in the Netherlands. J Clin Psychiatry. 2011;72(1):51–9.PubMedCrossRef

34.

De Jonghe F, De Maat S, Hendriksen M, Nooteboom A, Dekker J, Van HL. Short-term psychoanalytic supportive psychotherapy for depression. Psychoanal Inq. 2013;33(6):614–25.CrossRef

35.

Martin DJ, Garske JP, Davis MK. Relation of the therapeutic alliance with outcome and other variables: a meta-analytic review. J Consult Clin Psychol. 2000;68(3):438–50.PubMedCrossRef

36.

Hendriksen M, Peen J, Van R, Barber JP, Dekker J. Is the alliance always a predictor of change in psychotherapy for depression? Psychother Res. 2014;24(2):160–70.PubMedCrossRef

37.

Driessen E, Van HL, Don FJ, Peen J, Kool S, Westra D, et al. The efficacy of cognitive-behavioral therapy and psychodynamic therapy in the outpatient treatment of major depression: a randomized clinical trial. Am J Psychiatry. 2013;170(9):1041–50.PubMedCrossRef

38.

Arntz A, Jacob G. Schema therapy in practice. Chichester: Wiley; 2012.

39.

Beck AT, Steer, R.A., Brown, G.K., van der Does, A.J.W. BDI-II-NL-R Handleiding. 2016.

40.

Beck AT, Steer, R.A. & Brown, G. Manual for the Beck depression inventory-second edition (BDI-II). 1996.

41.

Whisman MA, Perez JE, Ramel W. Factor structure of the Beck depression inventory-second edition (BDI-II) in a student sample. J Clin Psychol. 2000;56(4):545–51.PubMedCrossRef

42.

Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck depression inventory: twenty-five years of evaluation. Clin Psychol Rev. 1988;8(1):77–100.CrossRef

43.

Luteijn F, Bouman TK. De validiteit van Beck’s Depression Inventory. Nederlands Tijdschrift voor de Psychologie. 1988;43:340–3.

44.

Vliet IMv, Leroy H, Megen HJGMv. MINI international neuropsychiatric interview (M.I.N.I.). Nederlandse versie 5.0.0 ed. 2000.

45.

Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, et al. The MINI international neuropsychiatric interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997;12(5):224–31.CrossRef

46.

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33. quiz 4–57PubMed

47.

First MB, Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for DSM-IV Axis II personality disorders, (SCID-II). Washington, D.C.: American Psychiatric Press, Inc.; 1997.

48.

Weertman A, Arntz A, Kerkhofs MLM. Gestructureerd Klinisch Interview voor DSM-IV As-II Persoonlijkheidsstoornissen (SCID-II): Lisse. Swets Test Publishers; 2000.

49.

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

50.

Maffei C, Fossati A, Agostoni I, Barraco A, Bagnato M, Deborah D, et al. Interrater reliability and internal consistency of the structured clinical interview for DSM-IV axis II personality disorders (SCID-II), version 2.0. J Personal Disord. 1997;11(3):279–84.CrossRef

51.

First MB, Williams JB, Benjamin LS, Spitzer RL. Structured clinical interview for DSM-5 personality disorders: SCID-5-PD. Arlington: American Psychiatric Association Publishing; 2016.

52.

First MB, Williams JB, Benjamin LS, & Spitzer RL. SCID-5-SPQ: Structured Clinical Interview for DSM-5 Screening Personality Questionnaire: Designed to be Used as a Screener for the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD). Arlington: American Psychiatric Association Publishing; 2016.

53.

Verheul R, Andrea H, Berghout CC, Dolan C, Busschbach JJ, van der Kroft PJ, et al. Severity indices of personality problems (SIPP-118): development, factor structure, reliability, and validity. Psychol Assess. 2008;20(1):23–34.PubMedCrossRef

54.

Rijkeboer MM. Schema-Vragenlijst Verkorte Vorm. Utrecht: Ambulatorium Universiteit Utrecht; 2008.

55.

Rijkeboer MM, van den B H, van den B J. Stability and discriminative power of the young Schema-questionnaire in a Dutch clinical versus non-clinical population. J Behav Ther Exp Psychiatry. 2005;36(2):129–44.PubMedCrossRef

56.

Baranoff J, Oei TP, Cho SH, Kwon SM. Factor structure and internal consistency of the young Schema questionnaire (short form) in Korean and Australian samples. J Affect Disord. 2006;93(1–3):133–40.PubMedCrossRef

57.

Young JE, Arntz A, Atkinson T, Lobbestael J, Weishaar M, Vreeswijk M, et al. The Schema mode inventory (SMI). New York: Schema Therapy Institute; 2007.

58.

Lobbestael J, Van Vreeswijk MF, Arntz A. An empirical test of schema mode conceptualizations in personality disorders. Behav Res Ther. 2008;46(7):854–60.PubMedCrossRef

59.

Lobbestael J, van V M, Spinhoven P, Schouten E, Arntz A. Reliability and validity of the short Schema mode inventory (SMI). Behav Cogn Psychother. 2010;38(4):437–58.PubMedCrossRef

60.

Polak MG, Van Riel L, Ingenhoven TJ, & Van HL. The Developmental Profile Inventory: Constructing a clinically useful self-report for levels of psychodynamic personality functioning. Journal of Psychiatric Practice. 2018;24(4):239-252.

61.

Polak M, Van HL, Overeem-Seldenrijk J, Heiser WJ, Abraham RE. The developmental profile: validation of a theory-driven instrument for personality assessment. Psychother Res. 2010;20(3):259–72. https://doi.org/10.1080/10503300903352701.CrossRefPubMed

62.

Beurs E. Brief symptom inventory. Handleiding. Lieden: Pits Publishers; 2004.

63.

Jong dK, Nugter MA, L MJ, Burlingame GM. Handleiding voor afname en scoring van de Outcome Questionaire OQ-45.2. Salt Lake City: OQ Measures LLC; 2009.

64.

Veenhoven R. Happiness Questionnaire.2014 http://worlddatabaseofhappiness.eur.nl/hap_quer/hqs_fp.htm.

65.

Hakkaart-van Roijen L, van Straten A, Donker M, Tiemens B. Trimbos/iMTA questionnaire for costs with psychiatric illness (TIC-P): Rotterdam. Institute for Medical Technology Assessment; 2002.

66.

Brooks R, Rabin R, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. London: Kluwer Academic Publishers; 2003.CrossRef

67.

Horvath AO, Greenberg LS. Development and validation of the working alliance inventory. J Couns Psychol. 1989;36(2):223–33.CrossRef

68.

Busseri MA, Tyler JD. Interchangeability of the working alliance inventory and working alliance inventory. Short Form Psychol Assess. 2003;15(2):193–7.PubMedCrossRef

69.

Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59(1):12–9.PubMedCrossRef

70.

Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated health economic evaluation reporting standards (CHEERS) statement. BMJ. 2013;346:f1049. https://doi.org/10.1136/bmj.f1049.CrossRefPubMed

71.

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. https://doi.org/10.1016/j.jval.2015.02.001.CrossRefPubMed

72.

Hakkaart-van Roijen L, van der Linden N, Bouwmans C, Kanters T, Tan SS. Kostenhandleiding: methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. Rotterdam: Institute for Medical Technology Assessment, Erasmus Universiteit Rotterdam; 2015.

73.

Debray TP, Vergouwe Y, Koffijberg H, Nieboer D, Steyerberg EW, Moons KG. A new framework to enhance the interpretation of external validation studies of clinical prediction models. J Clin Epidemiol. 2015;68(3):279–89. https://doi.org/10.1016/j.jclinepi.2014.06.018.CrossRefPubMed

74.

Driessen E, Hegelmaier LM, Abbass AA, Barber JP, Dekker JJ, Van HL, et al. The efficacy of short-term psychodynamic psychotherapy for depression: a meta-analysis update. Clin Psychol Rev. 2015;42:1–15. https://doi.org/10.1016/j.cpr.2015.07.004.CrossRefPubMed

75.

Norcross JC, Wampold BE. Evidence-based therapy relationships: research conclusions and clinical practices. Psychotherapy (Chic). 2011;48(1):98–102. https://doi.org/10.1037/a0022161.CrossRefPubMed

Title: Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): a pragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy
Authors: Marit Kool
Henricus L. Van
Anna Bartak
Saskia C. M. de Maat
Arnoud Arntz
Johanna W. van den Eshof
Jaap Peen
Matthijs Blankers
Judith E. Bosmans
Jack J. M. Dekker
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2018
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-018-1829-1

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): a pragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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