Contact information
Type
Scientific
Primary contact
Prof Andre Aleman
ORCID ID
Contact details
Department of Neurosciences
NeuroImaging Centre Groningen
Cognitive Neuropsychiatry
Ant. Deusinglaan 2
Groningen
9713 AW
Netherlands
a.aleman@med.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ABR 27146
Study information
Scientific title
Acronym
Study hypothesis
Current information as of 10/12/09:
The preconditions of poor insight in schizophrenia, self-reflection, idiosyncratic self-certainty and stigma sensitivity, can be improved by a treatment aiming to stimulate perspective taking and to decrease of internalized stigma.
Initial information at time of registration:
Can poor insight with schizophrenia be improved with a treatment aimed at self-reflection and the decrease of internalized stigmata?
Please note that as f 10/12/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date. In addition, please note that the target number of participants has been changed from 80 to 145. The anticipated start and end dates for this trial have been updated from 01/09/2009 and 01/09/2011 to 01/05/2010 and 01/10/2011.
Ethics approval
Added 10/12/09:
Approved by the Medical Ethical Testing Committee (METc) UMCG on 13th of October 2009
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psychic disorders; schizophrenia and other psychotic disorders
Intervention
Current information as of 10/12/09:
Patients will have 12 one-hour group therapy sessions with a psychologist. The training consists of three modules, each module consists of four group sessions. During these sessions patients are stimulated to reflect upon their own thoughts, behavior and feelings and integrate changes that have occurred during their illness in the self-image. They are constantly encouraged to distinguishing factual information from opinions and to take the perspective of others. The active control condition consists of group wise drill and practice cognitive remediation training.The total duration of the intervention will be 12 hours.
Initial information at time of registration:
Patients will have 16 group therapy sessions with a psychologist. In these sessions, stigmatising 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.
Control condition: care as usual and additional befriending sessions with a therapist.
The total duration of interventions will be 16 hours. Follow-up assessments will take 3 x 90 minutes.
Added 03/01/2011:
Added to the trial is a fMRI/MRS evaluation for 40 of the 145 patients in the study (20 patients and 20 controls). For the 20 patients the fMRI/MRS will be added before and after the psychosocial intervention/training. Duration: 2x 1 hour.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current information as of 10/12/09:
Self-reflection, idiosyncratic self-certainty and stigma sensitivity:
1. Beck Cognitive Insight Scale (BCIS)
2. Selfreflection and Insight Scale (ZRIS)
3. Internalised Stigma: Internalized Stigma of Mental Illness Scale (ISMIS)
Initial information at time of registration
Insight, assessed by the following:
1. Beck Cognitive Insight Scale (BCIS)
2. Schedule for the Assessment of Insight - Expanded Version (SAI-E)
Secondary outcome measures
Current information as of 10/12/09:
Depression, symptoms, self-esteem and quality of life:
1. Insight (SAI-E)
2. Depression: Beck Depression Inventory (BDI-II)
3. Symptoms: Positive and Negative Syndrome Scale (PANSS)
4. Self-esteem
5. Quality of life: Manchester Short Assessment of Quality of Life (MANSA)
Initial information at time of registration:
Social functioning, depression, internalised stigma, quality of life and symptoms will be assessed by the following:
1. Community Functioning: Social Functioning Scale
2. Depression: Beck Depression Inventory (BDI-II)
3. Symptoms: Positive and Negative Syndrome Scale (PANSS)
4. Internalised Stigma: Internalized Stigma of Mental Illness Scale (ISMIS)
5. Self-esteem: Self-Esteem Rating Scale (SERS) SF-20 (Dutch version)
6. Quality of life: Manchester Short Assessment of Quality of Life (MANSA)
Overall trial start date
01/05/2010
Overall trial end date
01/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age: 18 years or older
2. A diagnosis of schizophrenia according to Diagnostic And Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
3. Impaired insight (based on structured assessment) (PI< 9)
4. Internalized stigma (ISMIS items 6+13+17+18 <6 )
5. Able to give informed consent
Initial information at time of registration:
1. Both males and females, age between: 18-65
2. A diagnosis of schizophrenia according to Diagnostic And Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
3. Impaired insight (based on structured assessment)
4. Willing to give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added 10/12/09: 145
Participant exclusion criteria
Current information as of 10/12/09:
1. Florid psychosis
2. Co-morbid neurological disorder
Initial information at time of registration:
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
Recruitment start date
01/05/2010
Recruitment end date
01/10/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Neurosciences
Groningen
9713 AW
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (Netherlands)
Sponsor details
Hanzeplein 1
Groningen
9700 RB
Netherlands
a.aleman@med.umcg.nl
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
European Science Foundation/ The Netherlands Organization for Scientific Research (NWO) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21975132
Publication citations
-
Study protocol
Pijnenborg GH, Van der Gaag M, Bockting CL, Van der Meer L, Aleman A, REFLEX, a social-cognitive group treatment to improve insight in schizophrenia: study protocol of a multi-center RCT., BMC Psychiatry, 2011, 11, 161, doi: 10.1186/1471-244X-11-161.