Reflex

ISRCTN	ISRCTN50247539
DOI	https://doi.org/10.1186/ISRCTN50247539
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ABR 27146
Sponsor	University Medical Center Groningen (UMCG) (Netherlands)
Funder	European Science Foundation/ The Netherlands Organization for Scientific Research (NWO) (Netherlands)

Submission date: 04/05/2009
Registration date: 30/06/2009
Last edited: 18/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andre Aleman
Scientific

Department of Neurosciences
NeuroImaging Centre Groningen
Cognitive Neuropsychiatry
Ant. Deusinglaan 2
Groningen
9713 AW
Netherlands

Email	a.aleman@med.umcg.nl

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Reflex
Study objectives	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(s)	Added 10/12/09: Approved by the Medical Ethical Testing Committee (METc) UMCG on 13th of October 2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	145
Total final enrolment	121
Key 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
Key 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
Date of first enrolment	01/05/2010
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Neurosciences

Groningen
9713 AW
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2019	18/06/2020	Yes	No
Protocol article	study protocol	05/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/11/2019: Internal review.