SchizophreniaSCIT-VFNCT02667834
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
A study testing Social Cognition and Interaction Training (SCIT) and therapeutic education program (ETP) in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social Cognition and Interaction Training (SCIT) and therapeutic education program (ETP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Oct 2019
- 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
- Men and women aged 18 to 50 years old
- Diagnosis of schizophrenia according to the DSM-IV-TR
- French speaker
- Unchanged psychotropic treatment during month preceding the inclusion
- Patients having given their consent lit to participate in the study
- Patients not having been part of therapeutic education program during six months preceding the inclusion
- Affiliated to the French social security
Who cannot join
- Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco
- History of neurobiological illness or trauma
- Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)
- Simultaneous participation on another program of cognitive remediation
- The ineffectiveness of neuroleptic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia
Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.
Read the detailed description
This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.
160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.
- Conditions
- Schizophrenia
- Being tested
- Social Cognition and Interaction Training (SCIT), therapeutic education program (ETP)
- Keywords
- social cognition, cognitive remediation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition and Interaction Training (SCIT)Behavioural
A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders
therapeutic education program (ETP)Behavioural
usual treatment ,30 hours with therapist, only discussion between patients
| Study group | Role | What they receive |
|---|---|---|
| Social Cognition and Interaction Training (SCIT) | Experimental | SCIT Social cognition and interaction training program. Receives: Behavioral: Social Cognition and Interaction Training (SCIT) |
| Therapeutic education program (ETP) | Active comparator | Therapeutic education program Receives: Behavioral: therapeutic education program (ETP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Scale of Assessment of Negative Symptoms
Improvement of negative symptoms of schizophrenia in patients who received Social Cognition and Interaction Training (SCIT) program compared to patients receiving a Therapeutic Education Program (ETP), equivalent in number, duration and rhythm of sessions
Measured: 40 weeks
Secondary outcomes (1)
Change from baseline in positive and negative symptoms scale (PANSS)
Scales for clinical and psychosocial functioning measurement
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startOct 2014
- Primary completion30 Sep 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCK NICOLAS, PUPH, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667834
- Sponsor's protocol ID
- 2014-A00072-45
- Acronym
- SCIT-VF
- Status last verified
- Oct 2019
- First submitted
- 19 Jan 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT02667834
- Acronym / sponsor ID
- SCIT-VF / 2014-A00072-45
- Conditions
- Schizophrenia
- Keywords
- social cognition, cognitive remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.
Detailed description
This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.
160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Cognition and Interaction Training (SCIT) | Experimental | Behavioral: Social Cognition and Interaction Training (SCIT)SCIT Social cognition and interaction training program. |
| Therapeutic education program (ETP) | Active comparator | Behavioral: therapeutic education program (ETP)Therapeutic education program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women aged 18 to 50 years old
- Diagnosis of schizophrenia according to the DSM-IV-TR
- French speaker
- Unchanged psychotropic treatment during month preceding the inclusion
- Patients having given their consent lit to participate in the study
Key exclusion criteria (5 listed)
- Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco
- History of neurobiological illness or trauma
- Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)
- Simultaneous participation on another program of cognitive remediation
- The ineffectiveness of neuroleptic treatment
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 |
|---|---|---|
| Social Cognition and Interaction Training (SCIT)A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders | Behavioural | Social Cognition and Interaction Training (SCIT) |
| therapeutic education program (ETP)usual treatment ,30 hours with therapist, only discussion between patients | Behavioural | Therapeutic education program (ETP) |
Primary outcome
Change from baseline in Scale of Assessment of Negative Symptoms
Time frame: 40 weeks
Improvement of negative symptoms of schizophrenia in patients who received Social Cognition and Interaction Training (SCIT) program compared to patients receiving a Therapeutic Education Program (ETP), equivalent in number, duration and rhythm of sessions
1 secondary outcome
Change from baseline in positive and negative symptoms scale (PANSS)
Time frame: 40 weeks
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 30 Oct 2019.
- Individual participant dataSharing planned: No
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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.
FRANCK NICOLAS, PUPH principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition and Interaction Training (SCIT) and therapeutic education program (ETP) in people with Schizophrenia, run by Hôpital le Vinatier at 1 site 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 7 inclusion and 5 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline in Scale of Assessment of Negative Symptoms (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.