Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-20
SponsorNorthwell Health
About this trial
This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet Clinical High Risk (CHR) criteria on the Structured Interview for Psychosis Risk Syndromes, defined by the presence of at least one attenuated positive symptom at a moderate to severe level
A score representing 0.5 SD below the mean on Animal Naming, Trails A or BACS: Symbol Coding from the MATRICS Consensus Cognitive Battery (MCCB).
Disqualifiers
Any DSM 5 Schizophrenia-Spectrum diagnosis
Non-English speaking
Past or current history of a clinically significant central nervous system disorder (e.g., seizure disorder)
Estimated IQ<70
Trial design
Design model
Parallel
Treatments tested in this trial
SCORES (Specific COgnitive Remediation with Support)
BehavioralThis study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention. In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB. The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Speeded Cognitive TrainingExperimental treatment 1 intervention
Group B: Non-Speeded Cognitive TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
Change in processing speed domain score and individual measures within the domain.
Time frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)Secondary outcomes
1
Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)
Change in GF:Social score from baseline to follow up timepoints. The GF:Social scale scores range from 1 to 10 with higher scores representing better social functioning.
Time frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)2
SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)
Change in Total Positive Symptom score from baseline to follow up timepoints. Each of the 5 positive symptoms on the SOPS range from 0-6 (6 indicating a psychotic symptom).
Time frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwell Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov