| ISRCTN | ISRCTN50247539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50247539 |
| Secondary identifying numbers | ABR 27146 |
- 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
Not provided at time of registration
Contact information
Prof Andre Aleman
Scientific
Scientific
Department of Neurosciences
NeuroImaging Centre Groningen
Cognitive Neuropsychiatry
Ant. Deusinglaan 2
Groningen
9713 AW
Netherlands
| a.aleman@med.umcg.nl |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Reflex |
| 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(s) | Added 10/12/09: Approved by the Medical Ethical Testing Committee (METc) UMCG on 13th of October 2009 |
| 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 |
| Primary outcome measure | 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 study start date | 01/05/2010 |
| Overall study end date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added 10/12/09: 145 |
| Total final enrolment | 121 |
| 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 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
Study participating centre
Department of Neurosciences
Groningen
9713 AW
Netherlands
9713 AW
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (Netherlands)
University/education
University/education
Hanzeplein 1
Groningen
9700 RB
Netherlands
| a.aleman@med.umcg.nl | |
| Website | http://www.umcg.nl |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
European Science Foundation/ The Netherlands Organization for Scientific Research (NWO) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 05/10/2011 | Yes | No | |
| Results article | results | 01/04/2019 | 18/06/2020 | Yes | No |
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.
