Efficacy of Social Cognitive Training (SCT) in Recent-onset Psychosis

NCT03962426 | Unknown

• 1 other identifier: 972_961_PNKT_LKI
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  6 weeks

Secondary Outcomes (9)

• Global functioning - Social (GF-S) and Role (GF-R)

  6 weeks

• Global Assessment of Functioning (GAF)

  6 weeks

• Positive and Negative Syndrome Scale (PANSS)

  6 weeks

• Cognitive Domain - Social Cognition (SC)

  6 weeks

• Cognitive Domain - Speed of Processing (SoP)

  6 weeks

Study Arms (2)

Social Cognitive Training (SCT)

ACTIVE COMPARATOR

10 hours of computerized SCT using tablet with 30-minute sessions, 4-5 times per week

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

Interventions

SocialVille Social Cognitive Training DEVICE

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

Social Cognitive Training (SCT)

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Posit Science Corporation: collaborator

Study Sites (1)

LudwigMaximilians

München, Deutschland, 80336, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 30267047 BACKGROUND

• Nahum 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.

  PMID: 25267937 BACKGROUND

• Ramsay 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.

  PMID: 29159134 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Oliver Pogarell, Ph.D.

CONTACT

089440053447; oliver.pogarell@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ,PhD

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 24, 2019
• Study Start: May 1, 2016
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

DE (1)