CLINICAL TRIAL

Personalized Real-Time Motivational Enhancement (PRIME) App for Psychotic Disorders

Recruiting · < 65 · All Sexes · Minneapolis, MN

This study is evaluating whether a mobile intervention can improve cognition and motivation in people with early psychosis.

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About the trial for Psychotic Disorders

Eligible Conditions
Psychotic Disorders · Psychosis · Mental Disorders

Treatment Groups

This trial involves 2 different treatments. Personalized Real-Time Motivational Enhancement (PRIME) App is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Personalized Real-Time Motivational Enhancement (PRIME) App
DEVICE
Cognitive and Social Cognitive Training
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
Has access to a smartphone or other mobile device to use the PRIME app
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 18 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 18 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Personalized Real-Time Motivational Enhancement (PRIME) App will improve 12 primary outcomes, 1 secondary outcome, and 2 other outcomes in patients with Psychotic Disorders. Measurement will happen over the course of 6 months.

Tolerability of BrainHQ Cognitive Training & PRIME
6 MONTHS
This measure contains both qualitative and quantitative information. Participants will compete questionnaires regarding the tolerability for PRIME and the tolerability of BrainHQ cognitive training. A global score will be calculated and participants are categorized as low tolerability, medium tolerability, or high tolerability. Outcome will be reported as the number of participants in each tolerability category - low, medium, and high.
6 MONTHS
BrainHQ Cognitive Training Performance Data
6 MONTHS
The number of hours of training completed will be reported ranging from 0-20.
6 MONTHS
COMPASS-10
18 MONTHS
The Compass-10 scale consists of 10 items rated on a scale from 0 to 6, with higher scores indicating more severe symptoms of depression and anxiety. Outcome will be reported as 10 separate domain scores.
18 MONTHS
Quality of Life Scale - Abbreviated
18 MONTHS
The quality of life scale contains 9 items rated from 0 to 6, with higher scores indicating increased functioning/decreased symptom severity. Outcome is reported as 9 separate domain scores.
18 MONTHS
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Social Pleasure Score
18 MONTHS
MAPS-SR social pleasure questionnaire consists of 15 items with total scores ranging from 0-12, where higher scores indicate increased pathology in this domain. MAPS-SR social pleasure will be assessed at baseline, 6 months, 12 months, and 18 months.
18 MONTHS
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score
18 MONTHS
BIS/BAS BAS fun seeking questionnaire consists of 24 items with total scores ranging from 4-16, where higher scores indicate greater tendency to be influenced by novelty and seeking out new experiences. BIS/BAS BAS fun seeking will be assessed at baseline, 6 months, 12 months, and 18 months.
18 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes psychotic disorders?

The genetic profile of a child or adolescent with a first psychotic episode is not necessarily reflective of their risk of psychosis in adulthood. Understanding this genetic basis can facilitate the development of the most effective and cost-effective early intervention programs for schizophrenia.

Anonymous Patient Answer

What is psychotic disorders?

The presentation of psychotic disorders is varied; consequently, there are many diagnostic classifications. The simplest and most widely applied class descriptors are psychotic disorders, schizophrenia, and substance-induced psychotic symptoms. Although the psychotic spectrum is an excellent classification of psychotic disorders, there are many different classifications. Thus, it is of interest to summarize the most common and appropriate class descriptions used in medical literature, and their diagnostic capabilities and specific treatment options.

Anonymous Patient Answer

What are the signs of psychotic disorders?

In an unselected sample from the general population, signs of psychosis include confusion, an irregular, inappropriate mood, and hallucinations and delusions. All of these signs are more common in psychotic disorders and most of them are relatively easily detected by the general public (e.g., delusions).

Anonymous Patient Answer

What are common treatments for psychotic disorders?

The treatment of psychotic disorders is often long and difficult and many people with psychotic diseases either never receive treatment or are treated with many different medications which do not help. The majority of people with psychotic disorders have been on the same first line medication for long periods, a factor which may be associated with lack of treatment adherence to the medication. People with psychotic disorders frequently see many different psychiatrists, and if the prescribing is poor then this can have a negative effect on people with psychotic disorders who need prompt and correct treatment for the psychotic disorder.

Anonymous Patient Answer

How many people get psychotic disorders a year in the United States?

A total of about 1.1 million people would be diagnosed with psychotic disorders at some point in their life. As psychosis is a chronic, relapsing and often underdiagnosed disease there is significant scope for further research into its prevalence in this population in order to improve prognosis and treatment outcomes.

Anonymous Patient Answer

Can psychotic disorders be cured?

While individuals with psychotic disorders may not be able to be completely cured with psychotic disorder, some recovery does take place. The possibility of complete remission cannot be discounted.

Anonymous Patient Answer

Have there been other clinical trials involving personalized real-time motivational enhancement (prime) app?

There has been little evidence from clinical trials to show that apps can reduce risk factors for psychosis. However, given the strong potential of mobile phone based interventions for mental health research, the ongoing development and testing of personalized motivational enhancement apps may offer an exciting and innovative means of assessing the effect of personalised interventions. Clinical trials registration number: H_290729.

Anonymous Patient Answer

Is personalized real-time motivational enhancement (prime) app typically used in combination with any other treatments?

A personalized RE-MME app has the potential to improve treatment adherence to medication adherence, reduce symptoms, and consequently, improve outcomes of those with schizophrenia and chronic psychosis. A large RCT is warranted (N = 1400 participants). www.clinicaltrials.gov"

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Anonymous Patient Answer

What does personalized real-time motivational enhancement (prime) app usually treat?

Results from a recent clinical trial demonstrated the value of self-administrated clinical data in the provision of personalized tailored advice to patients to help them manage their medication. The combination of the drug monitoring and the information provided to each patient allowed the clinicians to personalise their treatment and thereby optimise results. The patients were more satisfied with the support from the clinicians through the use of a realtime app.

Anonymous Patient Answer

Is personalized real-time motivational enhancement (prime) app safe for people?

In a recent study, findings of this study show that people have an interest in the Prime application not only to optimize their physical and moods, but also their cognitive functions and motivation in everyday life, which can be used as a tool to provide more personalized support. The Prime app, as a potentially applicable and safe clinical tool, may motivate individuals with psychotic disorders to improve certain aspects of their lives that may not adequately be pursued otherwise, such as social competence.

Anonymous Patient Answer

How does personalized real-time motivational enhancement (prime) app work?

Patients treated with the Prime app reported improved medication adherence and self-efficacy, with no significant change in depressive symptoms. Moreover, patients using the Prime app reported better functioning and quality of life and had higher overall treatment satisfaction.

Anonymous Patient Answer

What is personalized real-time motivational enhancement (prime) app?

Given that the Internet has become an invaluable resource for many people affected by psychotic disorders, this study demonstrates the potential of an Internet-based treatment program to be valuable in a clinical setting to patients who are not able to tolerate being seen on an in-person therapy program.

Anonymous Patient Answer
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