Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
- Conditions
- Active ControlSchizophreniaPsychosisPsychotic DisordersPsychotic EpisodePsychotic Mood DisordersTreatmentPsychotic DepressionCognitive ImpairmentSchizoaffective Disorder
- Interventions
- Behavioral: Structured Cognitive Training & PRIMEBehavioral: Computer Games Control & PRIME
- Registration Number
- NCT02782442
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Primary study:
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 psychosis. We will perform a double-blind RCT in 120 participants with psychosis, comparing: 1) An evidence-based structured program of 30-35 hours of on-line cognitive and social cognitive training exercises (CT) 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" . Both conditions will be administered using personal smartphone devices and computers and all procedures will be conducted remotely, including on-line recruitment in locations all over the world. Using both per protocol and intent-to-treat analyses, we will determine clinical, cognitive, and functional effects after the intervention using operationalized assessments delivered remotely, and will determine their relationship to functional outcome measures at 6-month follow-up.
Both the active condition and the control condition will be provided through identical web portals designed for the study at no charge by Brain HQ (Posit Science, Inc.). PRIME, the personalized motivation coaching and social networking app, has been designed and developed by co-investigator Dr. Schlosser, supported by UCSF and NIMH. We will recruit a total of 204 subjects with psychosis to be stratified by age (18-40, 40-60) and education (\< 14 years, \>14 years) and randomly assigned to one of the two conditions.
Unblinded Cognitive Training Sub-Study:
During the debrief, participants will be asked if they would like to continue participating in the study and receive active cognitive training. If the participant agrees, they will sign a new consent form which covers the details of the next portion of the study. The data from their 6 month follow up appointment will be counted as their baseline data to reduce participant burden. They will start immediately with cognitive training and will continue through the 6 month follow up appointments, as above. Additionally, participants who enter into this study may be offered simultaneous participation in the PRIME Super Users sub-study (see below).
PRIME Super Users Sub-study:
As a super-user, PRIME members are asked to take on a peer-mentorship role in the community and maintain a certain level of activity within the application. Before offering participation in the sub-study, the study team will perform a case review to determine if PRIME would be beneficial to the individual, that they appear able to fulfill the role of a peer mentor, that they are likely to be consistently active within the community, and they are able to adhere to the PRIME code of conduct. Participants will sign informed consent before rejoining the community.
As super-users, participants will be asked to be active members within the community and to maintain activity of once a week, on average. Participants will be asked to notify study staff if they anticipate or experience any extended absences from the app for any reason so their access to the community will not be revoked. Super-users will participate in the community by making posts, sharing moments, and commenting on the posts of other community members (including ROAM participants, Super-Users, and coaches). They are encouraged to share stories from their experiences and offer advice to other users for making and achieving goals, dealing with symptoms, and improving quality of life.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Structured Cognitive Training & PRIME Structured Cognitive Training & PRIME Structured cognitive training consists of social cognition and auditory exercises. Computer Games Control & PRIME Computer Games Control & PRIME Computer games control condition comes in the official PositScience wrapper.
- Primary Outcome Measures
Name Time Method Change in Penn Computerized Neurocognitive Battery MATRICS Protocol (Penn CNB) Baseline, Immediately after Intervention, 6 Month Follow-Up A series of computerized tests administered remotely that measure performance accuracy and speed on specific neurocognitive domains
Change in Abbreviated Quality of Life Scale (aQLS) Baseline, Immediately after Intervention, 6 Month Follow-Up A semi-structured interview which evaluates psychosocial functional outcome. Item scores range from 0 to 6 with higher scores indicating a better outcome.
- Secondary Outcome Measures
Name Time Method Change in Motivation and Pleasure Scale (MAP-SR) Baseline, Immediately after Intervention, 6 Month Follow-Up A self-report measure of the severity of negative symptoms. Item scores range from 0 to 4 with higher scores indicating a better outcome.
Change in Behavioral Inhibition System/Behavioral Activation System (BIS-BAS) Baseline, Immediately after Interviention, 6 Month Follow-Up A self-report measure of motivation examining both motivation to avoid aversive outcomes and motivation to approach goal-oriented outcomes. Item scores range from 1 to 4. BIS: lower scores indicate more behavioral inhibition (a worse outcome). BAS: lower scores indicate more behavioral activation (a better outcome).
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 A semi-structured interview assessing the severity of negative and positive symptoms of psychosis. Item scores range from 0 to 100 with lower scores indicating a better outcome.
Change in Role Functioning Scale (RFS) Baseline, Immediately after Intervention, 6 Month Follow-Up A measure of the level of functioning in four domains: working productivity, independent living and self care, family network relationships, and immediate social network relationships. Item scores range from 1 to 7 with higher scores indicating a better outcome.
Trial Locations
- Locations (2)
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Minnesota, Dept of Psychiatry
🇺🇸Minneapolis, Minnesota, United States