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

NCT ID: NCT03962426

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Social Cognitive Training (SCT)

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

Group Type: ACTIVE_COMPARATOR

SocialVille Social Cognitive Training

Intervention Type: 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

Treatment as usual (TAU)

This arm is getting treatment as usual, meaning antipsychotic medication (any needed medication in general) and psychotherapy/occupational therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SocialVille Social Cognitive Training

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Posit Science Corporation

INDUSTRY

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Lana Kambeitz-Ilankovic

Principal Investigator ,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LudwigMaximilians

München, Deutschland, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Oliver Pogarell, Ph.D.

Role: CONTACT

oliver.pogarell@med.uni-muenchen.de

089440053447

Facility Contacts

Oliver Pogarell, PhD

Role: primary

oliver.pogarell@med.uni-muenchen.de

+49 89 4400 ext. 55540

Thomas Görlitz, Dipl-Ing

Role: backup

thomas.goerlitz@med.uni-muenchen.de

+49 89 4400 ext. 55861

References

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.

Reference Type: BACKGROUND

PMID: 30267047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25267937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29159134 (View on PubMed)

Other Identifiers

972_961_PNKT_LKI

Identifier Type: -

Identifier Source: org_study_id