1. To investigate the implementation of Schema Therapy (ST) in regular mental healthcare and investigate whether its effectiveness and cost-effectiveness is comparable to the original RCT (Outpatient Psychotherapy for Borderline Personality Disorder…
Bron
Verkorte titel
Aandoening
Out-patient Schema Therapy for patients with a borderline personality disorder.
Ambulante schematherapie voor patiënten met een borderline persoonlijkheidsstoornis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is the score on the BPDSI-IV, a DSM-IV BPD criteria- based semi structured interview: this 70- item index represents the current severity and frequency of the DSM-IV BPD manifestations. This instrument shows excellent psychometric features (Cronbach’s alpha = 0.85, interrater reliability, 0.99; validity and sensitivity to change; Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006). Previous research (Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006) found a cut-off score (Jacobson & Truax, 1991) of 15 between patients with BPD and controls, with a specificity of 0.97 and a sensitivity of 1.00.
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Recovery criterion:<br>
The recovery criterion is, therefore, defined as achieving a BPDSI-IV score of less than 15 and maintaining this score until the last assessment.
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Reliable change:<br>
A second criterion is reliable change (Jacobson & Truax, 1991), which reflects individual clinically significant improvement. For the BPDSI-IV, reliable change is achieved when improvement is at least 11.70 points at the last assessment (Giesen-Bloo et al., 2009).
Achtergrond van het onderzoek
Background:
Schema Therapy (ST) is an integrative psychotherapy based upon a cognitive schema model and aims at identifying and changing dysfunctional schemas and modes through cognitive, experiential and behavioral pathways. It is specifically developed for patients with personality disorders. Its (cost) effectiveness has been demonstrated in a randomized controlled trial [1,2]. However, no other studies have as yet replicated these findings and ST has not been tested in regular mental healthcare settings. This protocol describes a randomized clinical trial on the implementation of ST in the Netherlands.
Methods/Design:
The purpose of this paper is to report the study protocol of a multisite randomized 2-group design, testing the implementation of outpatient schema therapy for borderline patients in regular mental healthcare and determining the added value of therapist telephone availability outside office hours in case of crisis. Patients outcome measures will be assessed with a semi-structured interview and self-report measures on BPD, quality of life and general psychopathology at baseline, 6, 12 and 18 months. Intention-to-treat analyses will be executed with survival analysis for dichotomous variables, and one-sample t-tests and ANCOVAs for continuous variables with baseline as covariate and condition as between group factor. All tests will be two-tailed with a significance level of 5%.
Discussion:
The study will provide an answer to the question whether ST can be effectively implemented and whether phone support by the therapist has an additional value.
Doel van het onderzoek
1. To investigate the implementation of Schema Therapy (ST) in regular mental healthcare and investigate whether its effectiveness and cost-effectiveness is comparable to the original RCT (Outpatient Psychotherapy for Borderline Personality Disorder: A randomized trial of Schema Focused Therapy versus Transference Focused Therapy (Giesen-Bloo et al., (2006).Archives of General Psychiatry, 63, 649-58);
2. To investigate the added value of telelphone support outside office hours, provided by the therapist.
Onderzoeksopzet
BPDSI-IV: baseline, 6 months, 12 months, 18 months, follow-up three years, BPD-47, SCL-90, Young Schema Questionnaire, EuroQol, WHO Qol, Cost interview, WAI-T, WAI-P, idem all measures at baseline, 6 months, 12 months, 18 months and follow-up at three years.
Onderzoeksproduct en/of interventie
Schema Therapy with two sessions a week in the first year and one session a week in the second year. 50% of the patients will receive Schema Therapy with extra phone support outside office hours and 50% without extra phone support outside office hours.
Publiek
GGZinGeest,
A.J. Ernststraat 887
Amsterdam 1081 HL
The Netherlands
+31 (0)20 7885795
m.nadort@ggzingeest.nl
Wetenschappelijk
GGZinGeest,
A.J. Ernststraat 887
Amsterdam 1081 HL
The Netherlands
+31 (0)20 7885795
m.nadort@ggzingeest.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients (aged 18-60) are eligible to participate if their main diagnosis is a Borderline Personality Disorder according to the DSM-IV criteria. The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-II) (First, Gibbon, et al., 1997; Weertman, Arntz, et al., 2000) will be used for assessing the diagnosis BPD. In addition, the level of symptom severity should be > 20 on the Borderline Personality Disorder Severity Index (BPDSI-IV). (Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006). Co morbid axis-I and axis-II disorders are allowed as is medication use.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients are excluded from the study if they suffer from one or more of the following disorders: a psychotic disorder (except short, reactive psychotic episodes), bipolar disorder, dissociative identity disorder, antisocial personality disorder, attention deficit hyperactivity disorder, addiction of such severity that clinical detoxification is indicated (after which entering treatment is possible), psychiatric disorders secondary to medical conditions and mental retardation or if they do not have sufficient command of the Dutch language necessary to participate in the study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL1680 |
NTR-old | NTR1781 |
Ander register | ZonMw : 945-16-313 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |