|- candidate number||5694|
|- NTR Number||NTR1799|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2009|
|- Secondary IDs||27146 ABR |
|- Public Title||Reflex.|
|- Scientific Title||'Towards a cognitive- emotional intervention for insight in schizophrenia’.|
|- hypothesis||Can poor insight with schizophrenia be improved with a treatment aimed at selfreflection and the decrease of internalized stigma.|
|- Healt Condition(s) or Problem(s) studied||Schizophrenia, Psychotic disorders|
|- Inclusion criteria||1. A diagnosis of schizophrenia according to DSM-IV-TR criteria;|
2. Impaired insight (based on structured assessment);
3. Willing to give written informed consent.
|- Exclusion criteria||1. Florid psychosis;|
2. Patients falling under the BOPZ law, or who are unable to give informed consent according to the ‘Wet op Geneeskundige Behandelovereenkomsten’;
3. Co-morbid neurological disorder;
4. IQ below 75.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2011|
|- Target number of participants||80|
|- Interventions||Patients will have 16 group therapy sessions with a psychologist. In these sessions, stigmatizing beliefs are disputed and self-reflection is stimulated. On a daily basis SMS-messages will be sent to stimulate self-reflection. After a prompt patients are required to fill out a short form with short questions about their cognitions and emotions. Weekly group sessions will be based on the patients' responses.|
|- Primary outcome||Insight is the primary outcome measure.
The following instruments will be used:|
1. Beck Cognitive Insight Scale;
|- Secondary outcome||Social functioning, depression, internalized stigmata, quality of life and symptoms.|
1. Social Functioning Scale;
5. SERS-SF 20.
|- Timepoints||Start: 01-09-2009.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Pijnenborg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A. Aleman|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Many people with schizophrenia demonstrate impaired insight. It is often assumed that poor insight plays an important role in the negative prognosis of schizophrenia. Indeed, impaired insight has been linked to unfavourable outcome of the disease and poorer medication compliance. Impaired insight is therefore considered as one of the most prominent clinical symptoms of schizophrenia. There are a number of interventions to improve insight, but results of these interventions are mixed. We expect that insight in schizophrenia will increase by stimulating self-reflection. Based on a new model of insight in schizophrenia, a new intervention is developed and will be evaluated in a RCT. The primary objective is to enhance insight in individuals with psychosis. Secondary objectives are to enhance patients’ quality of life and community functioning. |
Design: A multi-centre randomised controlled trial, the intervention will be compared to treatment as usual.
Study population: 80 patients with psychosis and poor insight will be included and randomised over two conditions.
In the first part of the intervention stigmatizing beliefs are disputed and self-reflection is stimulated. Concurrently, SMS-messages will be send to patients on a daily basis to stimulate self-reflection and self-monitoring. The control condition exists of care as usual and additional befriending sessions with a therapist.
The primary outcome are the changes in two insight assessment instruments. Secondary outcome are changes in structured assessment of community functioning, depression, self-esteem, quality of life, internalised stigma and symptoms.
|- Main changes (audit trail)|
|- RECORD||7-mei-2009 - 30-sep-2009|