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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. We will recruit participants who are receiving care for early psychosis from clinics across the United States. We will compare outcomes from participants who receive treatment at coordinated specialty care (CSC) early psychosis clinics to those that receive standard community care. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.

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 data supports the effectiveness of the treatment Cognitive and Social Cognitive Training, Cognitive Training, Social Cognitive Training, Mobile Cognitive Training, Early Psychosis Coordinated Specialty Care, Coordinated Specialty Care (CSC) for Early Psychosis, Early Psychosis Intervention (EPI), Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App, Personalized Real-Time Intervention for Motivational Enhancement App, PRIME App?

Research shows that cognitive training and remediation can improve cognitive functions like memory and executive function in early psychosis, and the PRIME app helps enhance motivation by providing personalized goals and peer support. These interventions, when combined, have shown promise in improving social and occupational functioning in individuals with early psychosis. ^{1 2 3 4 5}

Is the Cognitive + Motivational Enhancement for Early Psychosis treatment safe for humans?

The research articles do not provide specific safety data for the Cognitive + Motivational Enhancement treatment, but they do not report any safety concerns, suggesting it is generally considered safe for use in humans. ^{1 2 3 4 6}

How is the Cognitive and Social Cognitive Training with PRIME App treatment different from other treatments for early psychosis?

This treatment is unique because it combines web-based cognitive and social cognitive training with a mobile app that provides a motivational coach and peer support, allowing for personalized goal setting and social networking, all of which can be accessed remotely. ^{1 2 3 5 7}

Research Team

Piper Meyer-Kalos, PhD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Eligibility Criteria

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

Participated in significant cognitive training programs within the last 3 years

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)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A Grant Report. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Addressing cognitive health in coordinated specialty care for early psychosis: Real-world perspectives. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive Training and Remediation in First-Episode Psychosis: A Literature Review. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Successful Implementation of Integrative Cognitive Remediation for Early Psychosis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Australia 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. [2023]