"Cognitive Training Delivered Remotely to Individuals With Psychosis
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/15/2018 |
| Start Date: | September 2016 |
| End Date: | April 2019 |
| Contact: | Neelu Ghiasi |
| Email: | roam@umn.edu |
| Phone: | 612-625-1586 |
The purpose of this study is to use remote methods and scalable interactive neurotechnology
to generate important data on the potential for remote targeted cognitive treatment in people
with schizophrenia. The investigators will perform a double-blind randomized control trial in
120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40
hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours
per week), delivered with an innovative digital application which provides users with a
motivation coach to set personalized goals and with secure social networking for peer
support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A
control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per
week over 12 weeks, delivered with a standard commercial goal-setting app, "Daily Goals".
to generate important data on the potential for remote targeted cognitive treatment in people
with schizophrenia. The investigators will perform a double-blind randomized control trial in
120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40
hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours
per week), delivered with an innovative digital application which provides users with a
motivation coach to set personalized goals and with secure social networking for peer
support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A
control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per
week over 12 weeks, delivered with a standard commercial goal-setting app, "Daily Goals".
A double-blind randomized control trial in schizophrenia, comparing: 1) The treatment
condition-- 40 hours of cognitive training over 12 weeks (~3.5 hours per week) in a
structured program of 10 hours of social cognition exercises followed by 30 hours of auditory
processing exercises, combined with the Personalized Real-time Intervention for Motivational
Enhancement (PRIME) coaching app; or 2) The active control condition-- free-choice access to
a broad range of cognitive exercises across various domains, encouraged at 3.5 hours per week
over 12 weeks, combined with the commercial Daily Goals app. The investigators will recruit
204 schizophrenia subjects to be stratified by age (18-40, 40-60) and education (<14 years,
>14 years) and randomly assigned to one of the two conditions. Subjects and assessors will be
blind to group assignment. The investigators will perform both per protocol and
intent-to-treat analyses.
condition-- 40 hours of cognitive training over 12 weeks (~3.5 hours per week) in a
structured program of 10 hours of social cognition exercises followed by 30 hours of auditory
processing exercises, combined with the Personalized Real-time Intervention for Motivational
Enhancement (PRIME) coaching app; or 2) The active control condition-- free-choice access to
a broad range of cognitive exercises across various domains, encouraged at 3.5 hours per week
over 12 weeks, combined with the commercial Daily Goals app. The investigators will recruit
204 schizophrenia subjects to be stratified by age (18-40, 40-60) and education (<14 years,
>14 years) and randomly assigned to one of the two conditions. Subjects and assessors will be
blind to group assignment. The investigators will perform both per protocol and
intent-to-treat analyses.
1. Eligible participants will have a Structured Clinical Interview for Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV) Axis I Disorders (SCID-I) confirmed
clinical diagnosis of schizophrenia or schizoaffective disorder.
2. Eligible participants must be in good general physical health.
3. Eligible participants must be between the ages of 18 and 60 years old.
4. Eligible participants must speak English as their first language.
5. Eligible participants must have no neurological disorder.
6. Eligible participants must have no psychiatric hospitalizations for at least 3 months
prior to study participation.
7. Eligible participants must be on stable doses of psychiatric medications for at least
one month prior to participation.
Subjects will be excluded if:
1. There is a history of substance dependence in the past 12 months determined by DSM
criteria.
2. They do not meet any of the aforementioned exclusion criteria.
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