Clinical trial NCT03962426: Efficacy of Social Cognitive Training (SCT) in Recent-onset Psychosis
Official title: Elucidating the Efficacy and Response to Social Cognitive Training (SCT) in Recent Onset Psychosis (ROP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Posit Science Corporation
First posted: 2019-05-24
Enrollment: 66
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Global cognition
timeFrame: 6 weeks
measure: Neural effects- Blood Oxygenation Level Dependent (BOLD) images
timeFrame: 6 weeks
measure: Decision scores of the ROP-HC classifier
timeFrame: 6 weeks
Secondary outcomes:
measure: Global functioning - Social (GF-S) and Role (GF-R)
timeFrame: 6 weeks
measure: Global Assessment of Functioning (GAF)
timeFrame: 6 weeks
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 6 weeks
measure: Cognitive Domain - Social Cognition (SC)
timeFrame: 6 weeks
measure: Cognitive Domain - Speed of Processing (SoP)
timeFrame: 6 weeks
measure: Cognitive Domain - Working Memory (WM)
timeFrame: 6 weeks
measure: Cognitive Domain - Verbal Learning (VL)
timeFrame: 6 weeks
measure: Cognitive Domain - Attention (Attn)
timeFrame: 6 weeks
measure: Cognitive Domain - Executive Functioning (EF)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: LudwigMaximilians
state: Deutschland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.