search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effectiveness of an algorithm of evidence-based treatments in patients with Obsessive-Compulsive Disorder


- candidate number3923
- NTR NumberNTR1444
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2008
- Secondary IDs97/211A VU University Medical Center
- Public TitleThe effectiveness of an algorithm of evidence-based treatments in patients with Obsessive-Compulsive Disorder
- Scientific TitleThe effectiveness of an algorithm of evidence-based treatments in patients with Obsessive-Compulsive Disorder
- ACRONYMN/A
- hypothesis1. Phase I:
Exposure in vivo with response prevention (ERP) performed by experienced behavior therapists is more effective than ERP performed by master clinical psychology students. Therapist-controlled ERP is more effective than self-controlled ERP. ERP performed by experienced behavior therapists leads to a lower drop-out rate than ERP performed by master clinical psychology students.

2. Phase II:
After 12-week treatment with exposure in vivo with response prevention, in non-responders, 12-week treatment with cognitive therapy is superior to 12-week treatment with fluvoxamine in patients with Obsessive Compulsive Disorder.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD), Selective serotonin reuptake inhibitors (SSRIs), Cognitive behavior therapy, Antidepressants, Fluvoxamine, Algorithm
- Inclusion criteria1. Main diagnosis of Obsessive Compulsive Disorder according to DSM-IV
2. Duration at least one year
3. Age > 16 years
4. Informed Consent
5. No treatment for OCD elsewhere
6. Willing and able to stop with antidepressant and/or antipsychotic treatment.
- Exclusion criteria1. Obsessions only
2. Suicidal intention
3. Organic brain disease
4. Past or present psychotic disorder
5. Psychoactive substance use disorder
6. Borderline or anti-social personality disorder
7. Pregnancy
8. CBT 6 months before inclusion
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1999
- planned closingdate1-jan-2005
- Target number of participants150
- InterventionsFirst Phase:
12-week exposure in vivo with response prevention (ERP). Participants were randomized to:
1. Therapist-controlled ERP performed by experienced behavior therapists;
2. Therapist-controlled ERP performed by clinical psychology students;
3. Self-controlled ERP performed by experienced behavior therapists;
4. Self-controlled ERP performed by clinical psychology students
Second Phase:
Non-responders of the first phase were randomised to 12 weeks treatment with:
1. Cognitive therapy;
2. Fluvoxamine.
- Primary outcomeYale-Brown Obsessive Compulsive Scale (Y-BOCS), measured by trained and weekly supervised interviewers who are blind to the treatment condition of the patients.
- Secondary outcome1. Padua Inventory-Revised (PI-R)
2. Anxiety Discomfort Scale (ADS)
3. Beck Depression Inventory (BDI)
- TimepointsFirst Phase:
Pretest and posttest after 12-weeks. In case of non-response (defined as improvement of less than 35% measured with the Y-BOCS) admittance to phase 2
Second Phase:
Pretest and posttest after 12 weeks
Follow-up measures after 3 and 12 months
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.J.L.M. Balkom, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.J.L.M. Balkom, van
- Sponsor/Initiator VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryPhase 1:
Background:
The importance of the therapistís education and experience for the successful behavior treatment of OCD has not been investigated. Data on the relative effectiveness of self-controlled versus therapist-controlled exposure in vivo with response prevention (ERP) have yielded conflicting results. The present study evaluated the effectiveness of different formats of ERP in a referred sample of Obsessive Compulsive Disorder (OCD) patients.

Method:
Of the 146 eligible outpatients with primary DSM-IV-defined OCD, 118 patients enrolled in this randomized controlled trial and were randomly assigned to 1) therapist-controlled ERP performed by experienced behavior therapists; 2) therapist-controlled ERP performed by master students of clinical psychology; 3) self-controlled ERP performed by experienced behavior therapists; and 4) self-controlled ERP performed by master students of clinical psychology. This trial was performed from January 1999 to January 2005.

Results:
The results clearly reveal that ERP can be effectively delivered in different ways. On the one hand patient-controlled ERP is as effective as therapist-controlled ERP and on the other hand ERP delivered by experienced behavior therapists is equally effective as ERP delivered by master student therapists in the treatment of OCD. There was no significant difference in clinical outcome between these different form of ERP at posttreatment.

Conclusions:
Our results suggest that master student-therapists may become effective in the deliverance of ERP with OCD patients . Our results suggest that less-experienced and no certified behavior therapist were as capable as the behavior therapists with long experience and specialty certification in treating OCD patients. However, all therapists were instructed to deliver a standardized treatment, and all were adequately trained and supervised. Furthermore, therapist-controlled ERP was not more effective than self-controlled ERP in patients with OCD.
- Main changes (audit trail)
- RECORD5-sep-2008 - 23-sep-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl