Group Schema Therapy is more effective and more cost-effective than treatment as usual for Borderline Personality Disorder. Two subforms of group Schema Therapy (with different ratio of group and individual sessions) will also be compared, and…
ID
Bron
Aandoening
Borderline Personality Disorder
Borderline Persoonlijkheidsstoornis
Ondersteuning
Central study costs paid by performer.
Local patient care costs covered by mental health care institutes.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Borderline Personality Disorder Severity Index, mean score.
Achtergrond van het onderzoek
In an international multicenter RCT two forms of group Schema Therapy for Borderline Personality Disorder will be compared to the usual treatment provided to these patients. Effectiveness, cost-effectivenss (with full economic analysis, incl cost-utility and cost-effectiveness), and stakeholders'opnions will be assessed. A secondary aim is to find out what format of group Schema Therapy is to be preferred: mainly group treatment, or the combination of group and individual treatment. the study will take place in at least 14 centers in the Netherlands, Germany, USA, UK, Sweden, Ireland and Australia. At each center min. 32 participants will be recruited, and randomized over the two forms of group Schema Therapy and treatment as usual. Experimental treatment will be provided for 2 years, and a last follow-up assessment will be done at year 3.
Doel van het onderzoek
Group Schema Therapy is more effective and more cost-effective than treatment as usual for Borderline Personality Disorder.
Two subforms of group Schema Therapy (with different ratio of group and individual sessions) will also be compared, and stakeholders' opinions will be investigated (patients, therapists).
Onderzoeksopzet
Baseline, 6,12,18, 24 months and 36 months.
Onderzoeksproduct en/of interventie
Experimental A: 118 group Schema Therapy sessions over 2 years with max. 17 individual sessions.
Experimental B: 63 group Schema Therapy over 2 years with max. 61 individual sessions.
Control: Treatment as usual - the standard treatment given for that patient at the treatment center.
Publiek
Arnoud Arntz
Maastricht 6200 MD
The Netherlands
+31 20 525 6810
a.r.arntz@uva.nl
Wetenschappelijk
Arnoud Arntz
Maastricht 6200 MD
The Netherlands
+31 20 525 6810
a.r.arntz@uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 18-65 year;
2. Primary DSM-IV diagnosis of BPD (assessed with the SCID-II interview);
3. BPD severity above 20 on the BPDSI interview;
4. Willingness to participate in the study (informed consent procedure);
5. Ability to participate in (group) treatment and research for 2 years (e.g., no plans to move to other city).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Lifetime psychotic disorder (short stress-related episodes are allowed, as described in DSM-IV BPD criterion 9);
2. IQ < 80 (in case of suspicion of low IQ, to be assessed with full intelligence test);
3. Unable to read, speak, or write the language used at the site (in case of suspicion an official language test is to
be used);
4. ADHD (when suspected on basis of self-report for the KID-SCID is used to assess ADHD);
5. Bipolar disorder type 1 (SCID-1);
6. Dissociative Identity Disorder (confirmed by senior investigators);
7. Full or sub-threshold (defined as one less than the number of criteria to qualify for the diagnosis ) narcissistic or antisocial personality disorder (SCID-2);
8. Substance dependence needing clinical detox (after detox and 2 months sobriety can be included);
9. Serious and/or unstable medical illness;
10. Previous schema therapy of more than 3 months duration.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Regulations given the privacy sensitive character of the data. Data and a data dictionary will be made available after publication, for at least 5 years. Requests for data sharing will be considered by the study board. Requests should be directed to a.r.arntz@uva.nl; requestors will need to sign a data access agreement.
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2266 |
| NTR-old | NTR2392 |
| CCMO | NL28016.068.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON43782 |