Cognitive + Motivational Enhancement for Early Psychosis

Overseen By Melissa Dalhoe, MSW, LICSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurological disorder, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 12-week mobile program designed to improve thinking skills and motivation in individuals experiencing early psychosis. The study compares outcomes between participants using the mobile intervention and those receiving standard care at specialized clinics. Participants must have shown psychosis symptoms within the last five years and have access to a smartphone and computer. The goal is to determine if the mobile program can impact real-world treatment settings. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have had significant changes to medications recently, suggesting that stable medication use is preferred.

What prior data suggests that this mobile intervention program is safe for individuals with early psychosis?

Research has shown that exercises to improve thinking skills can benefit people with psychosis. One study on these exercises found no serious side effects, indicating they are generally safe and well-tolerated.

Similarly, researchers tested the PRIME app, designed to boost motivation, in young people with schizophrenia and similar conditions. The app proved easy to use and effective in improving mood and motivation, without causing significant negative effects.

Overall, past studies have shown both the cognitive exercises and the PRIME app to be safe. This is reassuring for anyone considering joining a trial with these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for early psychosis because they combine cognitive and social cognitive training with a personalized mobile app, offering a fresh approach to enhancing motivation. Unlike traditional treatments that often focus solely on medication and therapy, this approach integrates technology through the PRIME app, providing real-time support and personalized coaching. This innovative method aims to boost motivation and engagement in young people, potentially leading to better outcomes by addressing cognitive and motivational aspects directly.

What evidence suggests that this trial's treatments could be effective for early psychosis?

Research has shown that training programs focused on thinking and social skills can help people with early psychosis. In this trial, one group will receive Cognitive and Social Cognitive Training combined with the PRIME app, designed to boost motivation. These programs enhance thinking and social interaction, helping manage symptoms and easing daily life. The PRIME app offers personalized support and has reduced negative thoughts and feelings. Together, these methods aim to improve thinking skills and motivation, offering hope for those with early psychosis. Participants in the other group will receive standard treatment in their early psychosis CSC program. ^{2 6 7 8 9}

Who Is on the Research Team?

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Piper Meyer-Kalos, PhD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 with early psychosis or related conditions, enrolled in a specialty care clinic. They must be stable (no recent hospitalization or active suicidal thoughts), have access to a smartphone and computer, speak English fluently, and have an IQ above 70.

Inclusion Criteria

Has access to a computer or tablet to complete cognitive training exercises and study assessments

Participants will show overall clinical stability as determined by interview measures. Generally, participants who have not been hospitalized within the last 30 days and do not have active suicidal ideation will be considered stable

I am in good health and can participate in all study activities.

Exclusion Criteria

I have a neurological condition that could affect my study participation.

Clinically significant substance abuse that is impeding the participant's ability to participate fully during enrollment, assessment, or training (i.e., is unable to remain sober)

Risk of suicidal behavior

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive a 12-week mobile intervention program targeting cognitive functioning and motivated behavior

12 weeks

Remote participation with own devices

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at 6 and 12 months post-training

18 months

2 follow-up appointments (virtual) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive and Social Cognitive Training
• Early Psychosis Coordinated Specialty Care
• Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App

Trial Overview The study tests a mobile intervention program targeting cognition and motivation over 12 weeks against usual treatment. Participants will use the PRIME App and cognitive training exercises at home, with follow-ups at 6 and 12 months post-training.

How Is the Trial Designed?

Group I: Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement Experimental Treatment 3 Interventions

The Mobile Intervention. 20 hours of training consisting of 10 hours of cognitive training exercises plus 10 hours of social cognitive training exercises will be delivered over the course of 12 weeks. Participants will also engage in the PRIME app on a smart phone and will receive personalized support from a motivation enhancement coach.

Group II: Treatment as Usual Active Control 1 Intervention

Participants will be treated as usual in their early psychosis CSC program and will not complete cognitive training or use the Personalized Real-Time Motivational Enhancement App.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Social cognition training, which includes targeted, broad-based, and comprehensive programs, shows promise in improving social interactions for individuals with psychosis, with targeted programs being the most effective.

While there is some evidence that Theory of Mind (ToM) can be improved through these interventions, other areas like facial affect recognition and attributional bias show less potential for change, indicating a need for further research to enhance the effectiveness of these training strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of social cognition training on recovery from psychosis. Henderson, AR.[2018]

The study involved 100 participants with psychosis spectrum disorders who underwent 30 hours of targeted cognitive training combined with a motivational app (PRIME), showing significant improvements in global cognition and attention, as well as motivation and symptoms of depression.

Participants using the TCT+PRIME intervention demonstrated greater gains in emotion recognition compared to those using a computer games control, indicating that this combined approach may be more effective in enhancing cognitive and motivational outcomes in individuals with psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. Fisher, M., Etter, K., Murray, A., et al.[2023]

A cognitive health toolkit was developed and implemented in 18 OnTrackNY teams, involving 933 participants, to assess and address cognitive strengths and weaknesses in individuals with first-episode psychosis.

Preliminary results showed that 43.9% of new admissions received cognitive assessments, leading to the identification of cognitive health needs in over half of participants, which facilitated targeted services like psychoeducation and skills training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toolkit for assessing and addressing cognitive health in early psychosis: Evaluation of feasibility and utility in a coordinated specialty care setting. Saperstein, AM., Medalia, A., Malinovsky, I., et al.[2023]

A survey of 53 clinicians from the OnTrackNY program revealed a strong belief in the importance of addressing cognitive health during the early phase of psychosis, with most clinicians recognizing a significant link between cognitive impairment and community functioning.

88% of clinicians expressed a high likelihood of adopting new cognitive health tools if provided, indicating a readiness to integrate compensatory approaches into their practices, but highlighting the need for systematic training to effectively implement these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing cognitive health in coordinated specialty care for early psychosis: Real-world perspectives. Saperstein, AM., Medalia, A., Bello, I., et al.[2023]

Cognitive training and remediation (CTR) interventions show promise in improving cognitive functions such as global cognition, verbal learning, memory, and executive function in individuals experiencing their first episode of psychosis, based on a review of ten randomized controlled trials.

While most studies reported cognitive improvements, the evidence for CTR's impact on social functioning was less consistent, indicating a need for further research to optimize treatment components for better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training and Remediation in First-Episode Psychosis: A Literature Review. Miley, K., Hadidi, N., Kaas, M., et al.[2021]

The project aims to enhance early psychosis treatment in Minnesota by implementing measurement-based care and a neuroscience-informed cognitive training program across 6 treatment teams, as part of the national EPINET initiative.

Participants will engage in a 12-week mobile intervention designed to improve cognitive and motivational deficits, with assessments conducted at multiple time points to evaluate both immediate and long-term effects, all of which can be done remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A Grant Report. Roisum, R., Jenkins, D., Fisher, M., et al.[2022]

Cognitive remediation has been shown to effectively treat cognitive dysfunction in individuals with early psychosis, and early intervention is linked to better outcomes.

Since its implementation in 2016, an integrative cognitive remediation program has been successfully integrated into standard care in Iceland, benefiting over 100 patients and demonstrating sustainability in a coordinated specialty care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Successful Implementation of Integrative Cognitive Remediation for Early Psychosis. Vidarsdottir, OG., Roberts, DL., Twamley, EW., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7863980/

Cognitive Training and Remediation in First-Episode Psychosis Early evidence suggests that social cognition training may lead to improved reward processing related to motivation in schizophrenia (Fisher et al., 2017).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124004761

Social cognition interventions for patients with first-episode ... This scoping review seeks to identify existing evidence of social cognition interventions for patients with first-episode psychosis.

3. jmir.org jmir.org/2023/1/e48634/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30605045/

Effectiveness of Cognitive Training in an Intensive ... Efficacy studies have demonstrated cognitive training can produce improvement in cognition, symptoms, and functional outcomes for psychosis. A ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01973270

Community-Based Cognitive Training in Early Schizophrenia The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10682932/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, barriers include ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7696401/

The Effect of Smartphone-Based Cognitive Training on ... The effect of smartphone-based cognitive training on the functional/cognitive markers of schizophrenia: a one-year randomized study.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215001324000416

Efficacy and safety of iclepertin (BI 425809) with adjunctive ... Research paper. Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia.

9. cotipplab.umn.edu cotipplab.umn.edu/cognitive-training-delivered-remotely-individuals-psychosis-roam

Cognitive Training Delivered Remotely to Individuals with ... The objective of this study is to assess the utility of remote mobile interventions for psychosis and their impact on behavior, cognition, and functioning. +.