Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) (NCT02782442) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
United States109 participantsStarted 2016-09-01
Plain-language summary
Primary study:
This study is a single-site, double-blind, randomized, controlled clinical trial to compare an evidence-based structured program of 30-35 hours of on-line cognitive and social cognitive training exercises performed over 16 weeks (\~2 hours per week), delivered with an innovative digital app which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, "PRIME" ; vs. 2) A control condition of computer games, encouraged at \~2 hours per week over 16 weeks, delivered with "PRIME".
Unblinded Cognitive Training Sub-Study:
Participants who were randomized to the computer games arm of the trial may be offered access to the active cognitive training at the end of their 6 month follow up appointments, if they still meet inclusion criteria.
PRIME Super Users Sub-Study:
Participants who have provided all follow up data to the initial study, including those who are currently enrolled in the Unblinded Cognitive Training sub-study, may be offered continued participation in the PRIME community as super-users.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. SCID confirmed clinical diagnosis of the following: schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, major depressive disorder with psychotic features, or bipolar disorder with psychotic features.
✓. Good general physical health.
✓. Between the ages of 18 and 60 years old at the time of screening.
✓. Be fluent in spoken and written English, in that the participant learned to speak English before the age of 12 or is able to demonstrate fluency in conversation with study staff, or through English language exams, such as TOEFL, or English language courses
✓. No neurological disorder.
✓. Have an outpatient status of at least 1 month prior to participation.
✓. Been on a stable dose of psychiatric medications for at least one month prior to participation (may include no medication).
✓. Have a personal smartphone
Exclusion criteria
What they're measuring
1
Change in Penn Computerized Neurocognitive Battery MATRICS Protocol (Penn CNB)
Timeframe: Baseline, Immediately after Intervention, 6 Month Follow-Up
2
Change in Abbreviated Quality of Life Scale (aQLS)
Timeframe: Baseline, Immediately after Intervention, 6 Month Follow-Up
. We will exclude participants with a history of severe substance abuse in the past 3 months determined by DSM criteria.
✕. Subject is unable to demostrate adequate decisional capacity, in the judgment of the consenting staff member, to make a choice about participating in the research study.
✕. Anyone who does not meet the aforementioned inclusion criteria.