|- candidate number||5700|
|- NTR Number||NTR1801|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mei-2009|
|- Secondary IDs|| |
|- Public Title||Is 'inference-based approach', een nieuwe psychotherapeutische behandeling voor patiŽnten met een obsessieve compulsieve stoornis met gering inzicht, effectiever dan een behandeling met cognitieve gedragstherapie? Een gerandomiseerd gecontroleerd onderzoek. |
|- Scientific Title||Inference-based approach treatment versus cognitive behavioral therapy in patients with obessive compulsive disorder with poor insight a randomized controlled trial.|
|- ACRONYM||OCD-IBA Trial|
|- hypothesis||In a sample of patients with obsessive compulsive disorder (OCD) with poor insight, treatment with 'inference-based approach' (IBA) is superior to cognitive behavioral therapy in decreasing OCD symptom severity.|
|- Healt Condition(s) or Problem(s) studied||Obsessive-compulsive disorder (OCD), Cognitive behavior therapy|
|- Inclusion criteria||1. Outpatients, older than 18 years of age, with a primary diagnosis of OCD with poor insight;|
2. Written informed consent.
|- Exclusion criteria||1. Psychotic disorders;|
2. Alcohol- and drug dependence.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-mei-2011|
|- Target number of participants||80|
|- Interventions||Inference-based approach (IBA): This treatment points mainly to enhancing reality testing. The purpose is to resolve obsessions by enabling the patient to better differentiate between actual situations as they can perceive by using their senses, versus imaginary situations.|
Control condition: Cognitive behavioral therapy.
|- Primary outcome||Yale-Brown Obsessive Compulsive Scale (Y-BOCS), an assessor-rated scale, measuring presence and severity of obsessive compulsive symptoms.|
|- Secondary outcome||1. Overvalued Ideation Scale (OVIS), an assessor-rated scale, measuring presence and severity of poor insight (overvalued ideation);|
2. Inferential Confusion Questionaire ICQ), a self-rated scale, measuring presence and severity of distorted inference processes occurring in OCD;
3. Proportion drop outs.
|- Timepoints||Baseline and posttest, after 24 weeks of treatment.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Mrs. H. Visser|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.J.L.M. Balkom, van|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Steun, Fonds Psychische Gezondheid, Utrecht|
|- Publications||Een nieuw verklaringsmodel voor de obsessieve-compulsieve stoornis
H.A.D. Visser, H.J.G.M. van Megen, P. Van Oppen, A.J.L.M. van Balkom
Tijdschrift voor Psychiatrie 2009 (4) 227-237.|
|- Brief summary||The aim of this project is to improve treatment options for OCD patients with poor insight (overvalued ideation). It studies whether Inference-Based Approach (IBA), a new form of psychotherapy that was specially developed for this subgroup of OCD patients, is more effective than Cognitive Behavioral Therapy (CBT). A recent cognitive model of OCD, the inferential confusion model, provides an explanation of poor insight. In addition, O'Connor and colleagues demonstrated in 2005 in Canada that IBA, which is based on the inferential confusion model, showed a greater clinical improvement for patients with OCD and poor insight.|
In this RCT, 80- patients with OCD and poor insight, recruited at the outpatient clinica of GGZ inGeest and GGZ Meerkanten will be randomised over IBA and CBT.
IBA is a new form of cognitive therapy which purposes to resolve obsessions by means of enhancing reality testing.
Patients with a primary diagnosis of OCD with poor insight are enrolled in the study.
Timepoints are basline and posttest, after 24 weeks of treatment.
The study will provide an answer to the question whether IBA is a useful treatment for OCD patients with high levels of poor insight.
|- Main changes (audit trail)|
|- RECORD||6-mei-2009 - 30-sep-2009|