|- candidate number||9167|
|- NTR Number||NTR2763|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-feb-2011|
|- Secondary IDs||2009/359 METC VU University, Amsterdam|
|- Public Title||Collaborative Care for patients with severe personality disorderss.|
|- Scientific Title||Collaborative Care for patients with severe borderline and NOS personality disorders: A comparative multiple case study on processes and outcomes.|
|- hypothesis||The hypothesis is that a Collaborative Care Program for patients with severe personality disorders improves quality of life and self management skills, and reduce destructive behaviour and other manifestations of the personality disorder in comparison with Care as Usual. |
|- Healt Condition(s) or Problem(s) studied||Personality disorder, Selfmanagement, Destructive behaviour, Suicidal behaviour|
|- Inclusion criteria||1. Patients with a DSM-IV diagnosis for Borderline Personality Disorder or Personality Disorder Not Otherwise Specified;|
2. Patients with a score > 15 on the Borderline Personality Disorder Severity Index;
3. Patients received care/treatment for more than 2 years;
4. Patients aged between 18-65.
|- Exclusion criteria||1. Patients who participate in a structured psychotherapeutic program at the moment of the study;|
2. Patients with insufficient command of the Dutch language for completing questionnaires;
3. Patients without informed consent statement.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||32|
|- Interventions||A Collaborative Care Program consisting of several interventions, including:|
1. Organization of care and contracting;
2. Forming of a Collaborative Care team;
3. Problem Solving Treatment;
4. Early Warning and early intervention;
5. Life Orientation;
The collaborative Care is executed by a collaborative care manager (nurse) who has the central control function in maintaining the coordination and continuity of care. The design is elaborated in a workbook for the patient and his nurse, which states the various interventions. The following interventions are executed by the nurse:
1. Working with a method of early detection and early intervention for destructive behaviour and drafting an alert plan;
2. Problem solving intervention in six session, given by the nurse;
3. Life orientation in which elements of the Solution Focused Treatment are used to discover and expand positive experiences and powers to get a more positively oriented life orientation;
4. Psycho-education, issued in the workbook and taken care of by the nurse.
An evaluation will be held every three months by the Collaborative Care team.
|- Primary outcome||1. Quality of life: Manchester Short Appraisal (MANSA);|
2. Borderline Personality Disorder Severity Index (BPDSI).
|- Secondary outcome||1. Destructive behaviours: BPDSI, Beck Scale for Suicide Ideation (BSSI), CAGE questions- adapted to include drugs (CAGE-AID), Suicide Behavior Attitude Questionnaire (SBAQ), Attitudes Towards Deliberate Self-Harm Questionnaire (ADSHQ);|
2. Health care use: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (Tic-P);
3. Psychosocial symptoms: Brief Symptom Inventory (BSI);
4. Patient satisfaction: Consumer Quality- index (CQ-index);
5. Quality of the therapeutic relationship: Scale to Asses Therapeutic Relationships in Community Mental Health Care (STAR);
6. Mastery: Pearlin’s Mastery Scale (PMS).
|- Timepoints||1. Baseline measure;|
2. 5 months (T1);
3. 9 months (T2).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| B. Stringer|
|- CONTACT for SCIENTIFIC QUERIES|| B. Stringer|
|- Sponsor/Initiator ||GGZ inGeest, Vrije Universiteit Amsterdam, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, GGZ Ingeest, Vrije Universiteit Amsterdam, Inholland University|
|- Brief summary||Background:|
Structured psychotherapy is recommended as the preferred treatment of personality disorders. A substantial group of patients, however, has no access to these therapies or does not benefit. For those patients who have no (longer) access to psychotherapy a Collaborative Care Program (CCP) is developed. Collaborative Care originated in somatic health care to increase shared decision making and to enhance self management skills of chronic patients. Nurses have a prominent position in CCP’s as they are responsible for optimal continuity and coordination of care. The aim of the CCP is to improve quality of life and self management skills, and reduce destructive behaviour and other manifestations of the personality disorder.
Quantitative and qualitative data are combined in a comparative multiple case study. This makes it possible to test the feasibility of the CCP, and also provides insight into the preliminary outcomes of CCP. Two treatment conditions will be compared, one in which the CCP is provided, the other in which Care as Usual is offered. In both conditions 16 patients will be included. The perspectives of patients, their informal carers and nurses are integrated in this study. Data (questionnaires, documents, and interviews) will be collected among these three groups of participants. The process of treatment and care within both research conditions is described with qualitative research methods. Additional quantitative data provide insight in the preliminary results of the CCP compared to CAU. With a stepped analysis plan the ‘black box’ of the application of the program will be revealed in order to understand which characteristics and influencing factors are indicative for positive or negative outcomes.
The present study is, as to the best of our knowledge, the first to examine Collaborative Care for patients with severe personality disorders receiving outpatient mental health care. With the chosen design we want to examine how and which elements of the CC Program could contribute to a better quality of life for the patients.
|- Main changes (audit trail)|
|- RECORD||25-feb-2011 - 3-dec-2012|