Prodromal Schizophrenia, Prodromal Symptoms, Psychosis
Conditions
Keywords
Clinical High Risk (CHR), Processing Speed, Social Functioning, Social Impairment, Social Skills, Adolescents, Cognitive Remediation
Brief summary
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.
Detailed description
This study evaluates the effectiveness of a cognitive remediation (CR) program plus group coaching and support designed to improve processing speed and, in turn, social functioning and attenuated positive symptoms in individual considered Clinical High Risk for psychosis. The SCORES (Specific COgnitive REmediation with Support) intervention is a novel Cognitive Remediation program combined with group coaching, performance-based rewards, game-like tasks, and educational elements to increase engagement and retention. The study is funded by a R61/R33 award. In the R61 phase, all participants were asked to complete 40 hours of Cognitive Remediation or brain training (4 hours per week/10 weeks) with a mid-point assessment (at 5 weeks) to determine the training dose needed to impact processing speed as measured by the Matrics Cognitive Consensus Battery. The current R33 (Phase 2) will look to replicate the results of the R61 and assess the specificity of the targeted intervention with the addition of a non-speeded cognitive training group..
Interventions
BEHAVIORALSCORES (Specific COgnitive Remediation with Support)
This 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.
Sponsors
National Institute of Mental Health (NIMH)
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The R33 study design will utilize a randomized intervention model. All participants will participate in cognitive training with small group support.One group will complete speeded cognitive training tasks and the other group will complete non-speeded cognitive training tasks.
Eligibility
Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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 * Significant head injury * Significant substance abuse * Significant visual or auditory impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB) | Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks) | Change in processing speed domain score and individual measures within the domain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Functioning: Social (GF:Social) scale (Phase 2/R33 only) | Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks) | 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. |
| SIPS/SOPS: Positive Symptoms (Phase 2/R33 only) | Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks) | 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). |
Countries
United States
Contacts
Primary ContactRicardo E Carrion, Ph.D.
Backup ContactDanielle McLaughlin, M.A.
Outcome results
None listed