SchizophreniaRemedRugbyNCT03775564
Effectiveness of the RemedRugby Program
A study testing REMEDRUGBY PROGRAM, TOUCH RUGBY PROGRAM and TAU in people with Schizophrenia and Social Cognition, run by Hospital Center Alpes-Isère at 8 sites in France.
Trial summary
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition". Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Social Cognition, Self Esteem
- What is being tested?
- REMEDRUGBY PROGRAM, TOUCH RUGBY PROGRAM and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesFrance
- Study dates
- Nov 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013).
- French mother tongue.
- psychotropic treatment unchanged during the month prior to inclusion.
- Patients who gave their informed consent to participate in the study.
- affiliated with a social security scheme or beneficiary of such a scheme
- Subject suitable for the practice of sport.
Who cannot join
- Recent dependence and abuse on cannabis or any other substance (DSM-V criteria), except tobacco.
- Neurological disorders of vascular, infectious or neurodegenerative origin.
- taking of medicinal products with a cerebral or psychic impact (e.g., corticosteroids).
- Inability to practice sport
- Pregnancy planned or in progress
- Simultaneous Participation in any other program of remediation of social cognition, training in social skills, self-esteem.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Ch Annecy-Genevois
Annecy, AURA, 74000
Ch Le Vinatier
Bron, Aura, 69678
Chs de La Savoie
Chambéry, AURA, 73000
Ch Sainte-Marie
Clermont-Ferrand, AURA, 63000
CHU de CLERMONT-FERRAND
Clermont-Ferrand, AURA, 63000
HCAlpesIsere
Saint-Égrève, AURA, 38120
Chu Saint-Etienne
Saint-Etienne, AURA, 42000
Chs Le Valmont
Valence, AURA, 26000
About this study
Official title: Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition".
"Social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life.
Read more
People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration.
The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.
- Conditions
- Schizophrenia, Social Cognition, Self Esteem, Empowerment, Recovery
- Being tested
- REMEDRUGBY PROGRAM, TOUCH RUGBY PROGRAM, TAU
- Medical subject headings
- Schizophrenia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMEDRUGBY PROGRAMOther
- 1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization.
- 2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing.
- 5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients.
- 8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed
- 10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog
- 12th General Debriefing session Including : - 3 tournaments
- 8 hours of Touch Rugby
TOUCH RUGBY PROGRAMOther
Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day
TAUOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| REMEDRUGBY | Experimental | TAU + RemedRugby Program Receives: Other: REMEDRUGBY PROGRAM; Other: TAU |
| TAU + TOUCH RUGBY | Active comparator | TAU + Touch Rugby Program Receives: Other: TOUCH RUGBY PROGRAM; Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movie to Assess Social Cognition (MASC)
Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Secondary outcomes (14)
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after social cognitive remediation
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Personal and Social Performance scale (PSP)
Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Self Esteem Rating Scale (SERS)
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Boston University Empowerment Scale (BUES)
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Internalized Stigma of Mental Illness (ISMI)
self-assessment of internalized stigma
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Stages of Recovery Instrument (STORI)
Self-assessment of personal recovery
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Social Perception and Knowledge (PerSo)
cognitive task to assess competence in perception of social situations and social knowledge
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Ambiguous Intentions and Hostility Questionnaire (AIHQ)
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1, maximum score 6) at a cognitive task to measure hostile social cognitive bias
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Questionnaire of Cognitive and Affective Empathy
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
French National Adult Reading Test (f-NART
cognitive task to assess premorbid intellectual quotient (IQ)
Measured: Baseline measure only
Trail Making Test A (TMT A)
cognitive task to assess speed of processing
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Trail Making Test B (TMT B)
cognitive task to assess reactive mental flexibility
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Self-assessment of Social Cognition (AcSo)
self-assessment of patient' perception of social cognitive deficits
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Commission Test (modified zoo test)
cognitive task to asess planification abilities
Measured: Changes between baseline function, after intervention and at 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study startNov 2014
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- RemedRugby program Vs TAU + TouchRugby
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Center Alpes-Isère
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Le Valmont (Valence), Hôpital le Vinatier, Centre Hospitalier Spécialisé de la Savoie (Chambéry), Centre Hospitalier Annecy Genevois, Centre Hospitalier Universitaire de Saint Etienne, Centre Hospitalier Sainte Marie de Clermont Ferrand, University Hospital, Clermont-Ferrand
- Responsible party
- Principal investigator, Dr Julien Dubreucq, Hospital Center Alpes-Isère
- Investigators
- Julien JD DUBREUCQ, MD, Principal investigator, Hospital Center Alpes-Isère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775564
- Sponsor's protocol ID
- 2014-A01612-45
- Acronym
- RemedRugby
- Status last verified
- Mar 2019
- First submitted
- 27 Jul 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abu-Akel A. A neurobiological mapping of theory of mind. Brain Res Brain Res Rev. 2003 Sep;43(1):29-40. doi: 10.1016/s0165-0173(03)00190-5.
PubMed 14499460Addington J, Addington D. Neurocognitive and social functioning in schizophrenia: a 2.5 year follow-up study. Schizophr Res. 2000 Jul 7;44(1):47-56. doi: 10.1016/s0920-9964(99)00160-7.
PubMed 10867311Addington J, Saeedi H, Addington D. Influence of social perception and social knowledge on cognitive and social functioning in early psychosis. Br J Psychiatry. 2006 Oct;189:373-8. doi: 10.1192/bjp.bp.105.021022.
PubMed 17012662Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.
PubMed 10484945Baudouin JY, Martin F, Tiberghien G, Verlut I, Franck N. Selective attention to facial emotion and identity in schizophrenia. Neuropsychologia. 2002;40(5):503-11. doi: 10.1016/s0028-3932(01)00114-2.
PubMed 11749980Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.
PubMed 2934210Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. doi: 10.1007/s11920-996-0035-x.
PubMed 11559478Bentall RP, Corcoran R, Howard R, Blackwood N, Kinderman P. Persecutory delusions: a review and theoretical integration. Clin Psychol Rev. 2001 Nov;21(8):1143-92. doi: 10.1016/s0272-7358(01)00106-4.
PubMed 11702511Bengtsson-Tops A. Mastery in patients with schizophrenia living in the community: relationship to sociodemographic and clinical characteristics, needs for care and support, and social network. J Psychiatr Ment Health Nurs. 2004 Jun;11(3):298-304. doi: 10.1111/j.1365-2850.2003.00718.x.
PubMed 15149377Bertrand MC, Sutton H, Achim AM, Malla AK, Lepage M. Social cognitive impairments in first episode psychosis. Schizophr Res. 2007 Sep;95(1-3):124-33. doi: 10.1016/j.schres.2007.05.033. Epub 2007 Jul 16.
PubMed 17630261Blair RJ. Responding to the emotions of others: dissociating forms of empathy through the study of typical and psychiatric populations. Conscious Cogn. 2005 Dec;14(4):698-718. doi: 10.1016/j.concog.2005.06.004. Epub 2005 Sep 12.
PubMed 16157488Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24. doi: 10.1093/oxfordjournals.schbul.a033336.
PubMed 9718633Bora E, Yucel M, Pantelis C. Theory of mind impairment in schizophrenia: meta-analysis. Schizophr Res. 2009 Apr;109(1-3):1-9. doi: 10.1016/j.schres.2008.12.020. Epub 2009 Feb 4.
PubMed 19195844Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.
PubMed 14572622Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.
PubMed 20347271
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
- ClinicalTrials.gov ID
- NCT03775564
- Acronym / sponsor ID
- RemedRugby / 2014-A01612-45
- Conditions
- Schizophrenia, Social Cognition, Self Esteem, Empowerment, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Center Alpes-IsèreUniversity, hospital or other
- Collaborators
- Centre Hospitalier Le Valmont (Valence), Hôpital le Vinatier, Centre Hospitalier Spécialisé de la Savoie (Chambéry), Centre Hospitalier Annecy Genevois, Centre Hospitalier Universitaire de Saint Etienne, Centre Hospitalier Sainte Marie de Clermont Ferrand, University Hospital, Clermont-Ferrand
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition".
"Social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life.
People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration.
The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RemedRugby program Vs TAU + TouchRugby
| Arm | Type | Receives |
|---|---|---|
| REMEDRUGBY | Experimental | Other: REMEDRUGBY PROGRAM, Other: TAUTAU + RemedRugby Program |
| TAU + TOUCH RUGBY | Active comparator | Other: TOUCH RUGBY PROGRAM, Other: TAUTAU + Touch Rugby Program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013).
- French mother tongue.
- psychotropic treatment unchanged during the month prior to inclusion.
- Patients who gave their informed consent to participate in the study.
- affiliated with a social security scheme or beneficiary of such a scheme
Key exclusion criteria (6 listed)
- Recent dependence and abuse on cannabis or any other substance (DSM-V criteria), except tobacco.
- Neurological disorders of vascular, infectious or neurodegenerative origin.
- taking of medicinal products with a cerebral or psychic impact (e.g., corticosteroids).
- Inability to practice sport
- Pregnancy planned or in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMEDRUGBY PROGRAM* 1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization. * 2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing. * 5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients. * 8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed * 10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog * 12th General Debriefing session Including : - 3 tournaments * 8 hours of Touch Rugby | Other | REMEDRUGBY |
| TOUCH RUGBY PROGRAMPractical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day | Other | TAU + TOUCH RUGBY |
| TAUTreatment as usual | Other | REMEDRUGBY, TAU + TOUCH RUGBY |
Primary outcome
Movie to Assess Social Cognition (MASC)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation
14 secondary outcomes
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Personal and Social Performance scale (PSP)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Self Esteem Rating Scale (SERS)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Boston University Empowerment Scale (BUES)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Internalized Stigma of Mental Illness (ISMI)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Stages of Recovery Instrument (STORI)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Social Perception and Knowledge (PerSo)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Ambiguous Intentions and Hostility Questionnaire (AIHQ)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Questionnaire of Cognitive and Affective Empathy
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
French National Adult Reading Test (f-NART
Time frame: Baseline measure only
Trail Making Test A (TMT A)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Trail Making Test B (TMT B)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Self-assessment of Social Cognition (AcSo)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Commission Test (modified zoo test)
Time frame: Changes between baseline function, after intervention and at 6 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 14499460Abu-Akel A. A neurobiological mapping of theory of mind. Brain Res Brain Res Rev. 2003 Sep;43(1):29-40. doi: 10.1016/s0165-0173(03)00190-5.
- Background: PubMed 10867311Addington J, Addington D. Neurocognitive and social functioning in schizophrenia: a 2.5 year follow-up study. Schizophr Res. 2000 Jul 7;44(1):47-56. doi: 10.1016/s0920-9964(99)00160-7.
- Background: PubMed 17012662Addington J, Saeedi H, Addington D. Influence of social perception and social knowledge on cognitive and social functioning in early psychosis. Br J Psychiatry. 2006 Oct;189:373-8. doi: 10.1192/bjp.bp.105.021022.
- Background: PubMed 10484945Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.
- Background: PubMed 11749980Baudouin JY, Martin F, Tiberghien G, Verlut I, Franck N. Selective attention to facial emotion and identity in schizophrenia. Neuropsychologia. 2002;40(5):503-11. doi: 10.1016/s0028-3932(01)00114-2.
- Background: PubMed 2934210Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.
- Background: PubMed 11559478Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. doi: 10.1007/s11920-996-0035-x.
- Background: PubMed 11702511Bentall RP, Corcoran R, Howard R, Blackwood N, Kinderman P. Persecutory delusions: a review and theoretical integration. Clin Psychol Rev. 2001 Nov;21(8):1143-92. doi: 10.1016/s0272-7358(01)00106-4.
- Background: PubMed 15149377Bengtsson-Tops A. Mastery in patients with schizophrenia living in the community: relationship to sociodemographic and clinical characteristics, needs for care and support, and social network. J Psychiatr Ment Health Nurs. 2004 Jun;11(3):298-304. doi: 10.1111/j.1365-2850.2003.00718.x.
- Background: PubMed 17630261Bertrand MC, Sutton H, Achim AM, Malla AK, Lepage M. Social cognitive impairments in first episode psychosis. Schizophr Res. 2007 Sep;95(1-3):124-33. doi: 10.1016/j.schres.2007.05.033. Epub 2007 Jul 16.
- Background: PubMed 16157488Blair RJ. Responding to the emotions of others: dissociating forms of empathy through the study of typical and psychiatric populations. Conscious Cogn. 2005 Dec;14(4):698-718. doi: 10.1016/j.concog.2005.06.004. Epub 2005 Sep 12.
- Background: PubMed 9718633Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24. doi: 10.1093/oxfordjournals.schbul.a033336.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien JD DUBREUCQ, MD principal investigator
Hospital Center Alpes-Isère
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMEDRUGBY PROGRAM, TOUCH RUGBY PROGRAM and TAU in people with Schizophrenia and Social Cognition, run by Hospital Center Alpes-Isère at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movie to Assess Social Cognition (MASC) (time frame: Changes between baseline function, after intervention and at 6 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775564, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.