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Implementation of out-patient schema-focused therapy for borderline personality disorder in regular mental healthcare.

Implementation of out-patient schema-focused therapy for borderline personality disorder in regular mental healthcare.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22039
Enrollment
62
Registered
2009-04-29
Start date
2005-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-patient Schema Therapy for patients with a borderline personality disorder. Ambulante schematherapie voor patiënten met een borderline persoonlijkheidsstoornis.

Interventions

Schema Therapy with two sessions a week in the first year and one session a week in the second year. 50% of the patients will receive Schema Therapy with extra phone support outside office hours and 5

Sponsors

ZonMw Grant application 945-16-313asand GGZinGeest
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients (aged 18-60) are eligible to participate if their main diagnosis is a Borderline Personality Disorder according to the DSM-IV criteria. The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-II) (First, Gibbon, et al., 1997; Weertman, Arntz, et al., 2000) will be used for assessing the diagnosis BPD. In addition, the level of symptom severity should be > 20 on the Borderline Personality Disorder Severity Index (BPDSI-IV). (Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006). Co morbid axis-I and axis-II disorders are allowed as is medication use.

Exclusion criteria

Exclusion criteria: Patients are excluded from the study if they suffer from one or more of the following disorders: a psychotic disorder (except short, reactive psychotic episodes), bipolar disorder, dissociative identity disorder, antisocial personality disorder, attention deficit hyperactivity disorder, addiction of such severity that clinical detoxification is indicated (after which entering treatment is possible), psychiatric disorders secondary to medical conditions and mental retardation or if they do not have sufficient command of the Dutch language necessary to participate in the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the score on the BPDSI-IV, a DSM-IV BPD criteria- based semi structured interview: this 70- item index represents the current severity and frequency of the DSM-IV BPD manifestations. This instrument shows excellent psychometric features (Cronbach’s alpha = 0.85, interrater reliability, 0.99; validity and sensitivity to change; Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006). Previous research (Arntz, van den Hoorn, et al., 2003; Giesen-Bloo, Wachters, et al., 2006) found a cut-off score (Jacobson & Truax, 1991) of 15 between patients with BPD and controls, with a specificity of 0.97 and a sensitivity of 1.00. Recovery criterion: The recovery criterion is, therefore, defined as achieving a BPDSI-IV score of less than 15 and maintaining this score until the last assessment. Reliable change: A second criterion is reliable change (Jacobson & Truax, 1991), which reflects individual clinically significant improvement. For the BPDSI-IV, reliable change is achieved when improvement is at least 11.70 points at the last assessment (Giesen-Bloo et al., 2009).

Secondary

MeasureTime frame
Information on demographic factors (age, gender, marital status, education and employment status) will be collected at baseline. A secondary outcome measure is quality of life, which will be assessed by means of two widely used and psychometrically sound self-report questionnaires: the EuroQol-thermometer and EQ-5D and the World Health Organisation Quality of Life Questionnaire (EuroQol Group, 1990; Dolan, 1997; Brooks, 1996; WHOQOL Group, 1998). The vertical EuroQol-thermometer rating indicates one’s experienced level between best (100) and worst (0) imaginable health status. The EQ-5D contains 5 dimensions: mobility, self care, daily activities, pain/discomfort and depression/anxiety. Each dimension is rated at three levels: no problems, some problems and major problems. EQ-5D health states can be converted into utility scores. The WHOQOL is a 100-item self-report questionnaire, and through the domains of physical health, psychological health, environment, personal convictions, social relationships and extent of independency, the WHO concept of quality of life is assessed. BPD-47, SCL-90, Young Schema Questionnaire. Other secondary outcome measures are general psychopathologic measures and measures of ST personality concepts, all in self-report format and with robust psychometric properties. These measures include the BPD Checklist on the burden of BPD-specific symptoms ( Giesen-Bloo, Arntz, et al., 2006) and the Symptom Checklist-90 for subjective experience of general psychopathology (Derogatis, Lipman, et al., 1973, Arrindell and Ettema (1986). A theory specific instrument is the Young Schema Questionnaire on schemas underlying Young’s theory (Rijkeboer, 2005, Rijkeboer, van den Bergh, et al., 2005; Schmidt, Joiner, et al., 1995; Sterk and Rijkeboer, 1997). Economic evaluation: In addition to the clinical evaluation, an economic evaluation will be performed to assess the cost-effectiveness of ST with versus ST without extra phone support outside office ho

Contacts

Public ContactM. Nadort
m.nadort@ggzingeest.nl+31 (0)20 7885795

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)