|- candidate number||8310|
|- NTR Number||NTR2470|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-aug-2010|
|- Secondary IDs||2010-KP-917 Commissie Ethiek voor de programmagroep Klinische psychologie, UvA|
|- Public Title||Therapeutic Assessment Study.|
|- Scientific Title||Testing the Treatment Utility of Therapeutic Assessment in Patients with Severe Personality Pathology: A RCT.|
|- hypothesis||A short semi-structured assessment intervention (TA) results in immediate gains in terms of:
1. Clinical distress;|
2. Hope/ demoralization;
3. Readiness for treatment (alliance, stage of change), as compared to a short action-oriented intervention of equal duration (‘4-gesprekken model’).
|- Healt Condition(s) or Problem(s) studied||Personality disorder, Therapeutic assessment|
|- Inclusion criteria||1. Patients on the Waiting list of the Viersprong;|
2. Between 18 and 65 years old;
3. Were assigned to one of the following treatment programs: IKDP, IOP, Kliniek, day-hospital or outpatient treatment programs;
4. Exhibiting (severe) personality pathology as operationalized as satisfying the criteria for one or more DSM Axis-II disorders.
|- Exclusion criteria||1. Insufficient command of the Dutch Language;|
2. Severe organic disorders;
3. Mental Retardation;
4. Primary Psychotic Disorder;
5. Autism- or other severe developmental disorders;
6. Suffer from dementia, delirium or bipolar disorder.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2011|
|- Target number of participants||80|
|- Interventions||Patients in the experimental group participate in a Therapeutic Assessment (TA) procedure. The full model TA follows a semi-structured format that involves a) an initial interview aimed at collaboratively formulating assessment questions, b) standard test administration, c) an
assessment interventions session, and d) the final feedback session. Individualized reports are subsequently provided (and may include amendments suggested by the patients).
Patients in the control group participate in supportive counselling (SC) sessions, following a modified protocol developed for short term clinical care ("4 gesprekken model"). The aim of this intervention is to get more insight into the most important (core) problem of the patient.
|- Primary outcome||1. Symptomatic Change (BSI);|
2. Demoralization (MMPI).
|- Secondary outcome||1. Self-esteem (Rosenberg);|
2. Motivation for Change.
|- Timepoints||1. Start-TA/SC;|
3. 6 weeks after TA/SC;
4. 6 weeks into treatment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hilde Saeger, de|
|- CONTACT for SCIENTIFIC QUERIES|| J.H. Kamphuis|
|- Sponsor/Initiator ||Psychotherapeutic Center 'The Viersprong'|
(Source(s) of Monetary or Material Support)
|PTC De Viersprong|
|- Brief summary||Background:|
More than ever, clinical assessment needs to demonstrate treatment utility, that is ‘the degree to which assessment [contributes] to beneficial treatment outcome’ (Hayes, Nelson, & Jarrett, 1987), to serve the economic aims of optimal allocation of scarce resources. The presumed paucity of research documenting the treatment utility of clinical assessment has even led some to advocate a reduction of its use in clinical practice.
The present proposal puts the treatment utility of Therapeutic Assessment (TA) to the test following a manipulated assessment design.
Patients with complex personality pathology will be randomized to either a) TA, or b) a short supportive counseling intervention (SC). Treatment outcome narrowly defined as symptomatic change as well as more broadly defined by self-esteem, motivation for change and demoralization will be compared immediately after assessment, at 6 weeks after assessment and 6 weeks into treatment. Both groups will be compared to a Waitlist Only (WL) group, using the Propensity Score method (demonstrated by Bartak et al., 2008). In addition, using an N=1 approach, the change process will be analyzed using a multiple baseline design.
Demonstrate treatment utility of Therapeutic Assessment for this group; expand repertoire of evidence-based assessment interventions.
|- Main changes (audit trail)|
|- RECORD||4-aug-2010 - 3-sep-2010|