Study Design and Timeline
DSM-5
DISORDERS, -20
In this recently completed double-blind randomized controlled trial (ClinicalTrials.gov: NCT02782442), participants were randomized to PRIME+30 hours of TCT or PRIME+30 hours of CG in a 1:1 ratio. Before enrolling participants, a random allocation sequence was created using a randomization generator. The sequence was stored in Box and concealed or inaccessible to study members blinded to the group assignment (ie, PRIME coaches and assessment staff). The sequence was accessible to our unblinded study coordinator who enrolled and randomized the participants.All of the study activities were completed remotely. Both groups used the PRIME app on their personal smartphones and completed cognitive training exercises or the CG on laptops or computers. The participants were asked to complete the following schedule of study activities: baseline assessments (weeks 0-3), intervention (weeks 4-20), postintervention assessments (weeks 21-23), and a 6-month follow-up assessment (weeks 49-50). The total time for study completion was approximately 1 year. Diagnosis was confirmed at baseline using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), Research Version (SCID-5-RV) and conducted through videoconferencing. Assessments of symptoms, functioning, motivation, and cognition at all 3 time points were also completed entirely remotely via videoconference, self-report surveys, and web-based cognitive batteries (refer to the “Measures” section for details). In total, 85% (85/100) of the participants enrolled before the COVID-19 pandemic and 15% (15/100) enrolled during the pandemic. During the COVID-19 pandemic, there was a decrease in enrollment and greater attrition during baseline assessments (ie, before randomization). Our final sample consisted of 100 randomized participants, which was a decrease from our original goal of 120 randomized participants.