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van CCT (UK)

van CCT (UK)

Toetsing van een geďntegreerd behandelprotocol voor patiënten met een bipolaire stoornis en een comorbide borderline persoonlijkheidskenmerken. Een randomized clinical trial.

- candidate number14925
- NTR NumberNTR4016
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2013
- Secondary IDs2012/470 METc VUmc registratienummer
- Public TitleToetsing van een geďntegreerd behandelprotocol voor patiënten met een bipolaire stoornis en een comorbide borderline persoonlijkheidskenmerken. Een randomized clinical trial.
- Scientific TitleThe addition of step ps in the treatment of patients with bipolar disorder and comorbid borderline personality features: a randomized controlled trial.
- hypothesisThis will be the first randomized controlled trial of an integrated intervention in patients with BD and comorbid BPF. Given the overlapping phenomenology, the research will contribute to better understanding of similarities and differences between the two disorders, and thus the complex diagnosis in daily treatment practice. It is also expected that a specific treatment lead to mood stability, increased quality of life and to less care consumption.
- Healt Condition(s) or Problem(s) studiedBipolar disorder, Borderline personality disorder
- Inclusion criteria• age 18 – 65
• diagnosis of bipolar disorder-I, bipolar disorder-II, or bipolar disorder-NOS
• comorbid borderline personality disorder or borderline personality features (at least 3 of 9 DSM-IV-TR criteria, including at least impulsivity and anger bursts).
- Exclusion criteria• hospitalization for suicide risk
• current severe depressive episode (IDS-SR > 38)
• current severe manic episode (YMRS > 20)
• currently having a separate treatment for substance abuse
• unable to understand Dutch language
• patients having received STEPPS/VERS in the past 2 years
• patients who participate external in a STEPPS/VERS training during inclusion
• patients currently receive a psychotherapy
• patients without informed consent
• unable to comply STEPPS protocol.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-aug-2013
- planned closingdate1-mrt-2016
- Target number of participants120
- InterventionsInvestigational treatment of the study will be the STEPPS training added to individual TAU for bipolar disorder. The STEPPS training is a group treatment developed for patients with BPD to improve their emotion regulation. The training consists of 20 weekly sessions of approximately 2,5 hours and consists of 4 parts: psycho-education, emotion regulation skills, behavioral skills and emotion handling plan.
Controle group recieve treatment as usual for bipolar disorder. Treatmernt as usual consists of three necessary modules:
pharmacotherapy, information and psych-education and interventions to improve self-management.
- Primary outcomePrimary outcomes will be the frequency and severity of manic and depressive episodes as well as symptoms, course and burden of borderline personality features.
- Secondary outcomeSecondary outcomes will be quality of life, utilizing mental healthcare and psychopathologic symptoms not related to bipolar disorder or borderline personality features.
- TimepointsAssessment will be at baseline, after intervention, 12 and 18 month follow-up.
- Trial web site
- statusplanned
- Sponsor/Initiator VU University Medical Center, Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryBipolar disorder (BD) and borderline personality disorder (BPD) both are severe and chronic psychiatric disorders. Both disorders have overlapping symptoms, and current research shows that the presence of a BPD or borderline personality features (BPF) has an adverse effect on the course of BD (estimated comorbidity = 6% - 30%). The limited research available shows a very unfavourable disease course, a worse prognosis and response to medication, longer treatment duration and frequent psychiatric admissions, higher drop-out, increased risk of substance abuse, increased risk of suicide and more limitations in social and occupational functioning. However, there is no research available on the effect of a psychotherapeutic treatment in this group. Well-designed research on the treatment in BD with comorbid BPD is rare. The study population consists of patients treated for BD at specialized outpatient clinics for BD in the Netherlands.
- Main changes (audit trail)
- RECORD28-mei-2013 - 14-jun-2013

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