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Efficacy and cost-effectiveness of Short-Term Inpatient Psychotherapy (STIP) as compared to outpatient psychotherapy: a randomized clinical trial among patients with personality disorders in the Netherlands.


- candidate number1957
- NTR NumberNTR583
- ISRCTNISRCTN99682667
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR30-jan-2006
- Secondary IDsN/A 
- Public TitleEfficacy and cost-effectiveness of Short-Term Inpatient Psychotherapy (STIP) as compared to outpatient psychotherapy: a randomized clinical trial among patients with personality disorders in the Netherlands.
- Scientific TitleEfficacy and cost-effectiveness of Short-Term Inpatient Psychotherapy (STIP) as compared to outpatient psychotherapy: a randomized clinical trial among patients with personality disorders in the Netherlands.
- ACRONYMN/A
- hypothesisIt is expected that STIP shows superior efficacy in terms of faster improvement in the first 12 months of the trial and a higher recovery rate at 24 months of follow-up. In addition, it is expected that the higher direct medical costs of STIP are compensated by higher reduction of indirect medical costs and productivity losses. Therefore, we hypothesize that STIP shows a superior cost-benefit ratio as well.
- Healt Condition(s) or Problem(s) studiedPersonality disorder
- Inclusion criteria1. DSM-IV diagnosis of one or more cluster B or C personality disorders or PDNOS (as evidenced by a semi-structured interview); 2. Personality pathology as focus of treatment; 3. Age at least 18; 4. Residing within a 30-mile circle around Centre of Psychotherapy De Viersprong in Halsteren (i.e., Rotterdam, Dordrecht, Breda, Antwerpen, Zeeland).
- Exclusion criteria1. Insufficient command of Dutch language; 2. Severe cognitive impairments; 3. Mental retardation or borderline intellectual functioning; 4. Severe Axis I comorbidity as indicated by the presence of chronic psychotic disorder, bipolar disorder or substance dependence; 5. A history of psychosis; 6. Past year teratment history including one of the treatments in the current study AND a clear rationale why repetition of that treatment is contraindicated.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-feb-2006
- planned closingdate15-feb-2009
- Target number of participants80
- InterventionsShort-term inpatient psychotherapy (STIP) and outpatient psychotherapy.
- Primary outcome1. Symptomatic improvement; 2. Structural improvement; 3. Functional improvement; 4. Quality of life.
- Secondary outcomeN/A
- Timepoints
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESPhD. Helene Andrea
- CONTACT for SCIENTIFIC QUERIESProf. PhD. Roel Verheul
- Sponsor/Initiator Viersprong Institute for Studies on Personality Disorders (VISPD)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryAnnouncement d.d 23-jan-2007: Stop PSILO trial We aimed to compare short-term inpatient psychotherapy (STIP) with long-term outpatient schema-focused therapy (SFT). Unfortunately, this trial has failed to succeed due to slow patient recruition, a large refusal rate and several methodological reasons. After five months of patient recruition, we had only been able to include one patient in the study. Eight other patients refused participation in the randomised trial, but were included in a parallel preference trial in which they received the treatment of their choice (either SFT or STIP). An important implication of this research failure may be that a randomised design is not feasible for all scientific studies. Patient preferences play an important role in this matter, especially when huge differences between the treatment conditions exist (for example in treatment length and setting) as in our study. Alternative designs should then be considered. Summary d.d. Jan-2006 Background: The effectiveness of Short-Term Inpatient Psychotherapy (STIP) for a wide range of personality disorders (PDs) has recently been shown by two naturalistic cohort studies. A conservative estimate for the effect size of this 3-month inpatient program ranges from 1.6 to 1.7, which can be considered (very) large as compared to effect sizes reported for alternative treatment programs. As to yet, the clinical utility and cost-effectiveness of STIP still requires to be established by comparison with less intensive (outpatient or day treatment) alternatives in a randomized study design. Aims: To investigate the (cost)effectiveness of STIP as compared to alternative psychotherapeutic programs designed for the treatment of patients with PDs. Method: Comparative Randomized Clinical Trial (RCT) among 80 patients with cluster B or C PDs and personality disorder not-otherwise-specified (PDNOS) who are able to cope with the high "pressure" exerted in the inpatient condition. The comparison (control) treatment is 12-month outpatient psychotherapy. The intake team is allowed to determine the theoretical frame of reference (either psychoanalytically or cognitive-behaviorally oriented) in the outpatient setting. Patients will be followed 24-36 months at multiple times of measurement (with intervals of 3-12 mo). The treatment outcome battery includes measures for symptom improvement, structural (personality) change, quality of life, social and occupational functioning, and care consumption. Cost-effectiveness will be computed as the ratio between quality of life improvement (a generic measure of effect), and direct and indirect medical costs. Relevance: This study is the first to compare inpatient and outpatient alternatives to the treatment of cluster B and C personality disorders and PDNOS, and has relevance to both health care management and policy (cost-effectiveness) and clinical practice (efficacy).
- Main changes (audit trail)
- RECORD30-jan-2006 - 23-jan-2007


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