Condition category
Mental and Behavioural Disorders
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helene Andrea

ORCID ID

Contact details

Viersprong Institute for Studies on Personality Disorders (VISPD)
P.O. Box 7
Halsteren
4660 AA
Netherlands
+31 (0)164 632200
helene.andrea@deviersprong.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR583

Study information

Scientific title

Acronym

Study hypothesis

It 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 hypothesise that STIP shows a superior cost-benefit ratio as well.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Personality disorder

Intervention

Short-term inpatient psychotherapy (STIP) versus 12-month outpatient psychotherapy

This trial was terminated in October 2006:

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 recruitment, a large refusal rate and several methodological reasons. After five months of patient recruitment, 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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Symptomatic improvement
2. Structural improvement
3. Functional improvement
4. Quality of life

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/02/2006

Overall trial end date

15/02/2009

Reason abandoned

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.

Eligibility

Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of one or more cluster B or C personality disorders or personality disorder not otherwise specified (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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. 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 treatment history including one of the treatments in the current study AND a clear rationale why repetition of that treatment is contraindicated

Recruitment start date

15/02/2006

Recruitment end date

15/02/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Viersprong Institute for Studies on Personality Disorders (VISPD)
Halsteren
4660 AA
Netherlands

Sponsor information

Organisation

Viersprong Institute for Studies on Personality Disorders (VISPD) (The Netherlands)

Sponsor details

P.O. Box 7
Halsteren
4660 AA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes