Condition category
Mental and Behavioural Disorders
Date applied
04/05/2009
Date assigned
30/06/2009
Last edited
10/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcg.nl

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

  1. 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.

Additional files

Editorial Notes