PsychosisNCT03962426
Efficacy of Social Cognitive Training (SCT) in Recent-onset Psychosis
A study testing SocialVille Social Cognitive Training in people with Psychosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Psychosis
- What is being tested?
- SocialVille Social Cognitive Training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to 29 Feb 2020
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Language skills sufficient for participation
- Sufficient capacity to consent
- Presence of Psychotic Syndrome (POPS) based on the Structured Interview for Prodromal Syndromes (any of the Scale of Prodromal Symptoms (SOPS) rated with a 6 + symptoms occurring daily for more than one week AND any of the SOPS scales scored 6 + symptoms seriously disorganizing or dangerous)
Who cannot join
- Intelligence Quotient (IQ) below 70
- insufficient hearing for neuro-cognitive testing
- current or past head trauma with loss of consciousness > 5 minutes
- current or past known neurological disorder of the brain
- current or past known somatic disorder potentially affecting the structure or functioning of the brain
- current or past alcohol dependency according to Diagnostic and Statistic Manual (DSM-IV)
Show all 9Show fewer
- polytoxicomania within the past six months
- inability to collect MRI data
- antipsychotic medication for more than 90 cumulative days at or above the minimum dosage allowed based on guidelines set by the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
LudwigMaximilians
München, Deutschland, 80336
Oliver Pogarell, PhD, +49 89 4400 ext. 55540, oliver.pogarell@med.uni-muenchen.de
Thomas Görlitz, Dipl-Ing, +49 89 4400 ext. 55861, thomas.goerlitz@med.uni-muenchen.de
About this study
Official title: Elucidating the Efficacy and Response to Social Cognitive Training (SCT) in Recent Onset Psychosis (ROP)
Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain.
The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition.
Read more
Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training.
In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging.
The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms.
For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.
- Conditions
- Psychosis
- Being tested
- SocialVille Social Cognitive Training
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocialVille Social Cognitive TrainingDevice
SocialVille exercises in this study include 4 exercises:
- Recognition: a speeded face matching task
- Face to Face: a speeded facial emotion matching task
- Gaze Match: a speeded gaze matching task
- Face Poke: a continuous performance task with facial expressions
| Study group | Role | What they receive |
|---|---|---|
| Social Cognitive Training (SCT) | Active comparator | 10 hours of computerized SCT using tablet with 30-minute sessions, 4-5 times per week Receives: Device: SocialVille Social Cognitive Training |
| Treatment as usual (TAU) | No intervention | This arm is getting treatment as usual, meaning antipsychotic medication (any needed medication in general) and psychotherapy/occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition
An average of all cognitive domains (social cognition: [DANVA], speed of processing: [TMT-A, VFS, DSST], working memory: [Digit Span tests (Forward and Backward)], verbal learning: [RAVLT immediate recall], Attention: [CPT-IP], executive functioning: [TMT-B, VFP]) will be done to calculate the z-score transformed (from -4 to 4) global cognition score. The change will be made between endpoint and baseline.
Measured: 6 weeks
Neural effects- Blood Oxygenation Level Dependent (BOLD) images
Changes in strength of BOLD images-resting state functional connectivity in the seeds medial prefrontal cortex (mPFC) and amygdala between baseline and follow-up testing. BOLD time series will first be extracted from a 10-millimeter (mm)-radius sphere centered at the coordinates (-1, 47, -4, Montreal Neurological Institute-MNI) for the mPFC. Similarly, BOLD time series will also be extracted for the amygdala, using a 6-mm-radius sphere centered at (-20, -5, -9). Using the Resting-State Data Analysis Toolkit, a correlation map will be produced by computing the Pearson correlation coefficients between the average time course that is extracted for each seed (mPFC and amygdala) and each voxel in the whole brain for every participant. Correlation coefficients will be then converted to z-values using Fisher's r-to-z transform to improve normality and allow for parametric testing. Higher correlational coefficients correspond to higher resting state functional connectivity.
Measured: 6 weeks
Decision scores of the ROP-HC classifier
A linear Support Vector Machine (SVM) algorithm was used to develop an independent model distinguishing healthy control (HC) and recent-onset psychosis (ROP) participants based on resting-state functional connectivity (rsFC). This model will be built to identify disorder-related brain rsFC signatures and depict a spectrum of "HC-likeness" to "ROP-likeness" based on this neuroimaging modality. To measure changes in disorder-related brain signatures as a result of SCT, the HC-ROP classifier will be applied using out-of-sample-cross-validation (OOCV) to the ROP patients in the training study sample. This would allow us to determine whether decision scores of patients who received SCT were more likely to shift across the SVM hyperplane according to their rsFC pattern in a particular direction (ranging from -1.5 to 1.5). Patients in the SCT condition were expected to show greater shifts in the "HC-like" direction (-negative) as opposite to "ROP-like" (+positive).
Measured: 6 weeks
Secondary outcomes (9)
Global functioning - Social (GF-S) and Role (GF-R)
This scale separates social and role functioning in early psychosis spectrum. The scale is rated from 0-10, the social scale assesses aspects of social functioning such as, peer relationships and conflicts, involvement with family and age appropriate intimate relationships. The role scale assesses aspects of role functioning including type of age appropriate role (school/work/homemaking), quality of role. Higher scores represent higher functioning.
Measured: 6 weeks
Global Assessment of Functioning (GAF)
The Global Assessment of Functioning (GAF) is is used to rate symptoms and disability, ranging from the highest of a 100 (extremely high functioning) to the lowest rating 1 (severely impaired). An example of the scoring criterion can be as follows
- 100 to 91: Superior functioning with no symptoms that impair functioning and 10 to 1: A person is in almost constant danger of hurting themselves or others, has made a serious suicidal act with clear expectation of death, or both (https://www. healthline.com/health/gaf-score/). It is also rated on 3 time points, namely: in lifetime, past year and past month.
Measured: 6 weeks
Positive and Negative Syndrome Scale (PANSS)
The PANSS consists of 30 items meant to gauge the Positive, Negative, and General Psychopathology scales, each rated from 1-7. Higher values indicate higher rate of psychopathology whereas lower values indicate lower rates of psychopathology.
Measured: 6 weeks
Cognitive Domain - Social Cognition (SC)
The Diagnostic Analysis of Nonverbal Accuracy (DANVA) is a test of social cognition measuring the ability to read nonverbal social information. Scores range from 0 to 24 correct responses and were z-score transformed based on the study sample. Higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Cognitive Domain - Speed of Processing (SoP)
Speed of processing was based on 3 neurocognitive tests:
- Trail Making Test: Part A (TMT-A)- A test of visual scanning and visuo- motor tracking (time to completion in milliseconds).
- Verbal Fluency: semantic (VFS)- A verbal index of speed of processing. The task is to recite as many words that belong to a particular category (animals) within 60 seconds (# of correct words).
- Wechsler Adult Intelligence Scale, 3rd ed., digit symbol coding task (DSST) - A measure of visuomotor speed within 90 seconds (# correct - maximum 90 items).
The three scores were z-score transformed based on the study sample and then combined (DSST - TMT-A + VFS). We subtract TMT-A because higher values represent worse performance in this measure, whereas VFS and DSST have higher scores representing better performance. For the z-score transformed scores that we will use higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Cognitive Domain - Working Memory (WM)
Wechsler Memory Scale, 3rd ed., digit span subtest (DS) - A measure of nonverbal working memory (sum of # correct forward and backwards - maximum 15). These scores were z-score transformed based on the study sample. Higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Cognitive Domain - Verbal Learning (VL)
Rey Auditory Verbal Learning Test (RAVLT) - A list of 15 words presented 5 times, which must be recalled from memory (total sum of correctly recalled words across 5 repetitions - maximum 75). These scores were z-score transformed based on the study sample. Higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Cognitive Domain - Attention (Attn)
Continuous Performance Task - Identical Pairs (CPT-IP) - A measure of attention and vigilance using the signal detection index (d' = hits - false alarms). These scores were also z-score transformed based on the study sample. Higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Cognitive Domain - Executive Functioning (EF)
Trail Making Test: Part B (TMT-B) - A test measuring cognitive flexibility and set shifting ability, connecting circles with a line alternating between letters and numbers (time to completion in milliseconds). Verbal Fluency: phonetic (VFP) - A verbal index of executive ability (# correct words). The two scores were z-score transformed based on the study sample and then combined (VFP - TMT-B). We subtract TMT-B because higher values represent worse performance in this measure. Higher z-scores stand for better performance and lower z-scores stand for worse performance (min -4.0, max +4.0).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study startMay 2016
- Primary completion29 Feb 2020 (estimated)
- Study completion29 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Posit Science Corporation
- Responsible party
- Principal investigator, Lana Kambeitz-Ilankovic, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962426
- Sponsor's protocol ID
- 972_961_PNKT_LKI
- Status last verified
- Jan 2020
- First submitted
- 15 May 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available on request.
Publications
Koutsouleris N, Kambeitz-Ilankovic L, Ruhrmann S, Rosen M, Ruef A, Dwyer DB, Paolini M, Chisholm K, Kambeitz J, Haidl T, Schmidt A, Gillam J, Schultze-Lutter F, Falkai P, Reiser M, Riecher-Rossler A, Upthegrove R, Hietala J, Salokangas RKR, Pantelis C, Meisenzahl E, Wood SJ, Beque D, Brambilla P, Borgwardt S; PRONIA Consortium. Prediction Models of Functional Outcomes for Individuals in the Clinical High-Risk State for Psychosis or With Recent-Onset Depression: A Multimodal, Multisite Machine Learning Analysis. JAMA Psychiatry. 2018 Nov 1;75(11):1156-1172. doi: 10.1001/jamapsychiatry.2018.2165.
PubMed 30267047Nahum M, Fisher M, Loewy R, Poelke G, Ventura J, Nuechterlein KH, Hooker CI, Green MF, Merzenich M, Vinogradov S. A novel, online social cognitive training program for young adults with schizophrenia: A pilot study. Schizophr Res Cogn. 2014 Mar 1;1(1):e11-e19. doi: 10.1016/j.scog.2014.01.003.
PubMed 25267937Ramsay IS, Ma S, Fisher M, Loewy RL, Ragland JD, Niendam T, Carter CS, Vinogradov S. Model selection and prediction of outcomes in recent onset schizophrenia patients who undergo cognitive training. Schizophr Res Cogn. 2017 Nov 8;11:1-5. doi: 10.1016/j.scog.2017.10.001. eCollection 2018 Mar.
PubMed 29159134
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Efficacy and Response to Social Cognitive Training (SCT) in Recent Onset Psychosis (ROP)
- ClinicalTrials.gov ID
- NCT03962426
- Acronym / sponsor ID
- 972_961_PNKT_LKI
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Posit Science Corporation
- Study start
- May 2016 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 24 May 2019 (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.
Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain.
The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition.
Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training.
In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging.
The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms.
For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Cognitive Training (SCT) | Active comparator | Device: SocialVille Social Cognitive Training10 hours of computerized SCT using tablet with 30-minute sessions, 4-5 times per week |
| Treatment as usual (TAU) | No intervention | –This arm is getting treatment as usual, meaning antipsychotic medication (any needed medication in general) and psychotherapy/occupational therapy |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Language skills sufficient for participation
- Sufficient capacity to consent
- Presence of Psychotic Syndrome (POPS) based on the Structured Interview for Prodromal Syndromes (any of the Scale of Prodromal Symptoms (SOPS) rated with a 6 + symptoms occurring daily for more than one week AND any of the SOPS scales scored 6 + symptoms seriously disorganizing or dangerous)
Key exclusion criteria (9 listed)
- Intelligence Quotient (IQ) below 70
- insufficient hearing for neuro-cognitive testing
- current or past head trauma with loss of consciousness > 5 minutes
- current or past known neurological disorder of the brain
- current or past known somatic disorder potentially affecting the structure or functioning of the brain
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 |
|---|---|---|
| SocialVille Social Cognitive TrainingSocialVille exercises in this study include 4 exercises: * Recognition: a speeded face matching task * Face to Face: a speeded facial emotion matching task * Gaze Match: a speeded gaze matching task * Face Poke: a continuous performance task with facial expressions | Device | Social Cognitive Training (SCT) |
Primary outcome
Global cognition
Time frame: 6 weeks
An average of all cognitive domains (social cognition: [DANVA], speed of processing: [TMT-A, VFS, DSST], working memory: [Digit Span tests (Forward and Backward)], verbal learning: [RAVLT immediate recall], Attention: [CPT-IP], executive functioning: [TMT-B, VFP]) will be done to calculate the z-score transformed (from -4 to 4) global cognition score. The change will be made between endpoint and baseline.
Neural effects- Blood Oxygenation Level Dependent (BOLD) images
Time frame: 6 weeks
Changes in strength of BOLD images-resting state functional connectivity in the seeds medial prefrontal cortex (mPFC) and amygdala between baseline and follow-up testing. BOLD time series will first be extracted from a 10-millimeter (mm)-radius sphere centered at the coordinates (-1, 47, -4, Montreal Neurological Institute-MNI) for the mPFC. Similarly, BOLD time series will also be extracted for the amygdala, using a 6-mm-radius sphere centered at (-20, -5, -9). Using the Resting-State Data Analysis Toolkit, a correlation map will be produced by computing the Pearson correlation coefficients between the average time course that is extracted for each seed (mPFC and amygdala) and each voxel in the whole brain for every participant. Correlation coefficients will be then converted to z-values using Fisher's r-to-z transform to improve normality and allow for parametric testing. Higher correlational coefficients correspond to higher resting state functional connectivity.
Decision scores of the ROP-HC classifier
Time frame: 6 weeks
A linear Support Vector Machine (SVM) algorithm was used to develop an independent model distinguishing healthy control (HC) and recent-onset psychosis (ROP) participants based on resting-state functional connectivity (rsFC). This model will be built to identify disorder-related brain rsFC signatures and depict a spectrum of "HC-likeness" to "ROP-likeness" based on this neuroimaging modality. To measure changes in disorder-related brain signatures as a result of SCT, the HC-ROP classifier will be applied using out-of-sample-cross-validation (OOCV) to the ROP patients in the training study sample. This would allow us to determine whether decision scores of patients who received SCT were more likely to shift across the SVM hyperplane according to their rsFC pattern in a particular direction (ranging from -1.5 to 1.5). Patients in the SCT condition were expected to show greater shifts in the "HC-like" direction (-negative) as opposite to "ROP-like" (+positive).
9 secondary outcomes
Global functioning - Social (GF-S) and Role (GF-R)
Time frame: 6 weeks
Global Assessment of Functioning (GAF)
Time frame: 6 weeks
Positive and Negative Syndrome Scale (PANSS)
Time frame: 6 weeks
Cognitive Domain - Social Cognition (SC)
Time frame: 6 weeks
Cognitive Domain - Speed of Processing (SoP)
Time frame: 6 weeks
Cognitive Domain - Working Memory (WM)
Time frame: 6 weeks
Cognitive Domain - Verbal Learning (VL)
Time frame: 6 weeks
Cognitive Domain - Attention (Attn)
Time frame: 6 weeks
Cognitive Domain - Executive Functioning (EF)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 30267047Koutsouleris N, Kambeitz-Ilankovic L, Ruhrmann S, Rosen M, Ruef A, Dwyer DB, Paolini M, Chisholm K, Kambeitz J, Haidl T, Schmidt A, Gillam J, Schultze-Lutter F, Falkai P, Reiser M, Riecher-Rossler A, Upthegrove R, Hietala J, Salokangas RKR, Pantelis C, Meisenzahl E, Wood SJ, Beque D, Brambilla P, Borgwardt S; PRONIA Consortium. Prediction Models of Functional Outcomes for Individuals in the Clinical High-Risk State for Psychosis or With Recent-Onset Depression: A Multimodal, Multisite Machine Learning Analysis. JAMA Psychiatry. 2018 Nov 1;75(11):1156-1172. doi: 10.1001/jamapsychiatry.2018.2165.
- Background: PubMed 25267937Nahum M, Fisher M, Loewy R, Poelke G, Ventura J, Nuechterlein KH, Hooker CI, Green MF, Merzenich M, Vinogradov S. A novel, online social cognitive training program for young adults with schizophrenia: A pilot study. Schizophr Res Cogn. 2014 Mar 1;1(1):e11-e19. doi: 10.1016/j.scog.2014.01.003.
- Background: PubMed 29159134Ramsay IS, Ma S, Fisher M, Loewy RL, Ragland JD, Niendam T, Carter CS, Vinogradov S. Model selection and prediction of outcomes in recent onset schizophrenia patients who undergo cognitive training. Schizophr Res Cogn. 2017 Nov 8;11:1-5. doi: 10.1016/j.scog.2017.10.001. eCollection 2018 Mar.
- Individual participant dataSharing planned: Undecided. Data will be made available on request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SocialVille Social Cognitive Training in people with Psychosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Pogarell, Ph.D. (089440053447, oliver.pogarell@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognition (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT03962426, which also lists 3 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 10 Jan 2020.