Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
1 other identifier
interventional
109
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
May 25, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2022
CompletedJune 8, 2022
June 1, 2022
5.5 years
March 14, 2016
June 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Penn Computerized Neurocognitive Battery MATRICS Protocol (Penn CNB)
A series of computerized tests administered remotely that measure performance accuracy and speed on specific neurocognitive domains
Baseline, Immediately after Intervention, 6 Month Follow-Up
Change in Abbreviated Quality of Life Scale (aQLS)
A semi-structured interview which evaluates psychosocial functional outcome. Item scores range from 0 to 6 with higher scores indicating a better outcome.
Baseline, Immediately after Intervention, 6 Month Follow-Up
Secondary Outcomes (4)
Change in Behavioral Inhibition System/Behavioral Activation System (BIS-BAS)
Baseline, Immediately after Interviention, 6 Month Follow-Up
Change in Motivation and Pleasure Scale (MAP-SR)
Baseline, Immediately after Intervention, 6 Month Follow-Up
Change in Role Functioning Scale (RFS)
Baseline, Immediately after Intervention, 6 Month Follow-Up
Change in Quick Scale for the Assessment of Negative Symptoms/Quick Scale for the Assessment of Positive Symptoms (Q-SANS/Q-SAPS)
Baseline, Immediately after Intervention, 6 Month Follow-Up
Study Arms (2)
Structured Cognitive Training & PRIME
EXPERIMENTALStructured cognitive training consists of social cognition and auditory exercises.
Computer Games Control & PRIME
ACTIVE COMPARATORComputer games control condition comes in the official PositScience wrapper.
Interventions
The treatment condition-- 30-35 hours of CT over 16 weeks (\~2 hours per week) is a structured program of 20 hours of auditory processing exercises followed by 10 hours of social cognition exercises, combined with the personalized PRIME coaching application
Computer games control condition which comes in the official PositScience wrapper. 30-35 hours of games over 16 weeks (\~2 hours per week), combined with the personalized PRIME coaching application.
Eligibility Criteria
You may qualify if:
- 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
- Have access to a computer.
- No prior cognitive training experience within the past 3 years.
- Pregnant women may participate in this study.
- Has completed 6 month assessments for ROAM
- Was randomized to the control condition (computer games) and did not receive active cognitive training.
- Has participated in the 6 month assessments for ROAM
- Has shown adequate participation in PRIME during the ROAM study (e.g., active in PRIME community once a week on average)
- +4 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- University of California, San Franciscocollaborator
Study Sites (2)
University of California San Francisco
San Francisco, California, 94117, United States
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
Fisher M, Etter K, Murray A, Ghiasi N, LaCross K, Ramsay I, Currie A, Fitzpatrick K, Biagianti B, Schlosser D, Loewy R, Vinogradov S. The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. J Med Internet Res. 2023 Nov 13;25:e48634. doi: 10.2196/48634.
PMID: 37955951DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophia Vinogradov, MD
University of Minnesota Department of Psychiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
May 25, 2016
Study Start
September 1, 2016
Primary Completion
March 12, 2022
Study Completion
March 12, 2022
Last Updated
June 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- De-identified data will first be available for sharing 6 months after first publication of results. There is no planned end date to availability of data after release.
- Access Criteria
- Collaborators must request permission of the PI for access to the data. Additionally, any interested parties must complete a Data Use Agreement for access to the data.
Primary outcome data will be shared with the NIH Data Archive in the National Database for Clinical Trials related to Mental Illness. De-identified data will be available for sharing with other researchers upon request. Data will not be released until 6 months after the first publication of results from this study. The protocol, consent documents, statistical analysis plan, and analytic code may be made available upon request, per PI discretion. In addition to the primary and secondary outcome measures listed above, there are several experimental measures which have been collected in this study. These data may also be available for sharing with other researchers upon request.