TreatmentNCT02782442
Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
A study testing Structured Cognitive Training & PRIME in people with Treatment and Active Control, run by University of Minnesota at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment, Active Control, Schizophrenia
- What is being tested?
- Structured Cognitive Training & PRIME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 12 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
- Inclusion Criteria for Unblinded Cognitive Training Sub-Study:
- Continues to meet inclusion criteria for ROAM (except for access to smart phone)
- 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)
- Has adhered to the PRIME App and Study Rules
- Is clinically stable and, in the opinion of the study staff and PRIME coaches, does not pose a risk to themselves or the PRIME community by continuing participation.
- Is capable of participating in the PRIME community independently with minimal support from study staff or PRIME coaches.
- Had a positive experience with the PRIME community and appears to be capable of positively contributing to the community.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55454
University of California San Francisco
San Francisco, California, 94117
About this study
Official title: Cognitive Training Delivered Remotely to Individuals With Psychosis
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".
Read more
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.
Read the 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.
- Conditions
- Treatment, Active Control, Schizophrenia, Psychosis, Schizoaffective Disorder, Psychotic Depression
- Being tested
- Structured Cognitive Training & PRIME, Computer Games Control & PRIME
- Keywords
- Cognitive Training, Motivation Enhancement
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Affective Disorders, Psychotic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Cognitive Training & PRIMEBehavioural
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 & PRIMEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Cognitive Training & PRIME | Experimental | Structured cognitive training consists of social cognition and auditory exercises. Receives: Behavioral: Structured Cognitive Training & PRIME |
| Computer Games Control & PRIME | Active comparator | Computer games control condition comes in the official PositScience wrapper. Receives: Behavioral: Computer Games Control & PRIME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, Immediately after Intervention, 6 Month Follow-Up
Secondary outcomes (4)
Change in Behavioral Inhibition System/Behavioral Activation System (BIS-BAS)
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).
Measured: Baseline, Immediately after Interviention, 6 Month Follow-Up
Change in Motivation and Pleasure Scale (MAP-SR)
A self-report measure of the severity of negative symptoms. Item scores range from 0 to 4 with higher scores indicating a better outcome.
Measured: Baseline, Immediately after Intervention, 6 Month Follow-Up
Change in Role Functioning Scale (RFS)
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.
Measured: 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)
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.
Measured: Baseline, Immediately after Intervention, 6 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start1 Sep 2016
- Primary completion12 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of Minnesota Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782442
- Sponsor's protocol ID
- PSYCH-2016-24813
- Status last verified
- Jun 2022
- First submitted
- 14 Mar 2016
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37955951
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training Delivered Remotely to Individuals With Psychosis
- ClinicalTrials.gov ID
- NCT02782442
- Acronym / sponsor ID
- PSYCH-2016-24813
- Conditions
- Treatment, Active Control, Schizophrenia, Psychosis, Schizoaffective Disorder, Psychotic Depression
- Keywords
- Cognitive Training, Motivation Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Cognitive Training & PRIME | Experimental | Behavioral: Structured Cognitive Training & PRIMEStructured cognitive training consists of social cognition and auditory exercises. |
| Computer Games Control & PRIME | Active comparator | Behavioral: Computer Games Control & PRIMEComputer games control condition comes in the official PositScience wrapper. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Cognitive Training & PRIMEThe 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 | Behavioural | Structured Cognitive Training & PRIME |
| Computer Games Control & PRIMEComputer 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. | Behavioural | Computer Games Control & PRIME |
Primary outcome
Change in Penn Computerized Neurocognitive Battery MATRICS Protocol (Penn CNB)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Change in Behavioral Inhibition System/Behavioral Activation System (BIS-BAS)
Time frame: Baseline, Immediately after Interviention, 6 Month Follow-Up
Change in Motivation and Pleasure Scale (MAP-SR)
Time frame: Baseline, Immediately after Intervention, 6 Month Follow-Up
Change in Role Functioning Scale (RFS)
Time frame: 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)
Time frame: Baseline, Immediately after Intervention, 6 Month Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 37955951Fisher 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Vinogradov, MD principal investigator
University of Minnesota Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Cognitive Training & PRIME in people with Treatment and Active Control, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penn Computerized Neurocognitive Battery MATRICS Protocol (Penn CNB) (time frame: Baseline, Immediately after Intervention, 6 Month Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.