Efficacy and cost-effectiveness of short-term inpatient psychotherapy (STIP) as compared to outpatient psychotherapy: a randomised clinical trial among patients with personality disorders in the Netherlands

ISRCTN	ISRCTN99682667
DOI	https://doi.org/10.1186/ISRCTN99682667
Secondary identifying numbers	NTR583

Submission date: 08/03/2006
Registration date: 08/03/2006
Last edited: 05/11/2008

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helene Andrea
Scientific

Viersprong Institute for Studies on Personality Disorders (VISPD)
P.O. Box 7
Halsteren
4660 AA
Netherlands

Phone	+31 (0)164 632200
Email	helene.andrea@deviersprong.nl

Study information

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Symptomatic improvement 2. Structural improvement 3. Functional improvement 4. Quality of life
Secondary outcome measures	No secondary outcome measures
Overall study start date	15/02/2006
Completion date	15/02/2009
Reason abandoned (if study stopped)	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 type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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)
Key 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
Date of first enrolment	15/02/2006
Date of final enrolment	15/02/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Viersprong Institute for Studies on Personality Disorders (VISPD)

Halsteren
4660 AA
Netherlands

Sponsor information

Viersprong Institute for Studies on Personality Disorders (VISPD) (The Netherlands)
Not defined

P.O. Box 7
Halsteren
4660 AA
Netherlands

"ROR"	https://ror.org/048jnwk41

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan