InVEST Program for High Risk for Psychosis

(InVEST Trial)

Overseen By Michelle West

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Full psychosis diagnosis, others

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

Compensation: Varies

Number of Visits: 2

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called InVEST (Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis), which aims to help young people at risk for psychosis improve daily role functioning, such as managing school or work. Initially, the study will test the program on a small group to evaluate its effectiveness and gather feedback. It will then compare InVEST with a delayed version to determine if immediate participation is more effective. Suitable participants are those aged 12-22 who are at risk of psychosis and experience mild difficulties in daily role activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative support strategies for young people at risk of psychosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the InVEST program is safe for individuals at high risk for psychosis?

Research shows that the InVEST program, designed for individuals at high risk for psychosis, lacks specific safety data from existing studies. However, as a behavioral program rather than a medication, it is generally considered low-risk. The program aids young people in enhancing their daily activities and role performance, suggesting it is manageable for participants.

Sources have not reported negative effects, so potential participants can reasonably consider the program safe to try. Nonetheless, discussing any concerns with the study team or a healthcare provider before joining is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the InVEST program for individuals at high risk for psychosis because it offers a novel approach to early intervention. Unlike traditional treatments that often focus on managing symptoms after they appear, InVEST emphasizes proactive strategies to potentially prevent or delay the onset of psychosis. This program is unique because it combines tailored cognitive training and support strategies over a four-month period, which might enhance cognitive resilience and improve outcomes. By intervening early, InVEST aims to change the trajectory of the condition, offering hope for better long-term mental health.

What evidence suggests that InVEST is effective for high risk for psychosis?

Research shows that people at high risk for psychosis often struggle with managing daily tasks and responsibilities. InVEST, which participants in this trial may receive, aims to help with these challenges by offering personalized job and education support. Studies on similar programs, such as Supported Employment, suggest they improve how people handle daily tasks. This leads researchers to hope that InVEST could positively impact those at high risk for psychosis by helping them better manage their everyday roles and responsibilities. ^{1 6 7 8 9}

Who Is on the Research Team?

Michelle Friedman-Yakoobian, PHD

Principal Investigator

Department of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 12-18 who are at high risk for psychosis, as determined by a specific interview process. They must have some difficulty with daily roles and their parent must agree to allow communication between the trial coaches and treatment providers.

Inclusion Criteria

I am between 12 and 22 years old.

Meets broad CHR-P criteria based on the Structured Interview for Psychosis Risk Syndromes (SIPS)

Shows at least mild role functioning impairment on the Global Functioning-Role scale (GF:R)

Exclusion Criteria

Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes

Does not meet inclusion criteria listed above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Development Phase/Open Trial

Preliminary open trial of InVEST to collect feasibility and acceptability data, refine recruitment approaches, and modify the treatment manual.

4 months

Weekly sessions (in-person or virtual)

Pilot Study Phase

Randomized trial comparing InVEST treatment vs. Delayed InVEST to explore preliminary evidence of efficacy.

8 months

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• InVEST

Trial Overview The InVEST program is being tested in two parts: an initial phase to assess feasibility and refine methods, followed by a randomized controlled trial comparing immediate InVEST intervention against delayed (DI) intervention to evaluate its effectiveness in improving role functioning.

How Is the Trial Designed?

Group I: InVEST Experimental Treatment 1 Intervention

4 month treatment condition

Group II: delayed invest Active Control 1 Intervention

participants in delayed invest wait four months and are reassessed before taking part in the intervention

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

The SEEearly trial is a randomized controlled trial involving 184 participants with early psychosis, aiming to assess the effectiveness of Supported Employment and Education (SEE) combined with standard treatment compared to standard treatment alone.

The primary outcome focuses on achieving steady participation in competitive employment or mainstream education for at least 50% of the 12-month follow-up, with the hypothesis that the SEE intervention will lead to significantly better outcomes in employment and education compared to treatment as usual.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing educational and vocational recovery in adolescents and young adults with early psychosis through Supported Employment and Education (SEEearly): study protocol for a multicenter randomized controlled trial. Jäckel, D., Willert, A., Brose, A., et al.[2023]

Early Intervention Services (EIS) for psychosis have been successfully implemented worldwide, particularly in regions like the UK and Quebec, focusing on reducing treatment delays and enhancing engagement in specialized care for young people experiencing their first episode of psychosis.

Research, including a meta-analysis, shows that EIS are more effective than standard treatments in reducing hospitalizations, relapses, and improving social functioning, emphasizing the importance of essential components like outreach, rapid access to care, and a range of biopsychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early Detection and Intervention for Psychosis: Why and How?] Bertulies-Esposito, B., Sicotte, R., Iyer, SN., et al.[2022]

The Individual Placement and Support (IPS) model for first-episode psychosis patients requires an average of 92 minutes per client per week, with a significant portion of time dedicated to direct client contact and travel.

The time commitment for IPS services decreases over the duration of enrollment and is higher when clients are actively seeking work or school placements, suggesting that funding should accommodate the full range of IPS activities to ensure effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personnel time required for supported employment and education services for individuals in a recent-onset psychosis treatment program. Humensky, JL., Turner, LR., Dixon, LB., et al.[2022]

The study reviewed 56 studies on Clinical High Risk for Psychosis (CHR-P) services across 15 countries, highlighting that most services (80.4%) use integrated multidisciplinary teams to support individuals aged 12-35, with a focus on clinical monitoring and various therapeutic interventions.

Key outcomes from these services include tracking symptom persistence and transition to psychosis, with recommendations provided to enhance the implementation of CHR-P services globally, aiming to improve early intervention and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a clinical service to prevent psychosis: What, how and when? Systematic review. Salazar de Pablo, G., Estradé, A., Cutroni, M., et al.[2023]

The study demonstrated that implementing Individual Placement and Support (IPS) within a clinical service for individuals at high risk of psychosis is feasible, with a low dropout rate of 16.1% and 83.9% of participants completing the program over an average of nine sessions.

At the 6-month follow-up, 73.1% of participants were employed, working more hours and earning significantly higher salaries compared to their baseline, indicating that IPS may effectively support employment outcomes for young people at clinical high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual placement and support focusing on employment and education for young people at clinical high risk of psychosis: A feasibility study. Del Piccolo, MC., Valmaggia, L., Henderson, C., et al.[2023]

The targeted case identification intervention significantly increased referrals to the clinical high-risk unit for first-episode psychosis, with a notable rise in eligible cases (P = 0.01 and P = 0.03, respectively).

The majority of referrals came from the first-episode psychosis service, indicating that integrated outreach strategies can effectively enhance the identification of individuals at high risk for psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated outreach intervention targeting multiple stages of early psychosis improve the identification of individuals at clinical high risk? McIlwaine, SV., Jordan, G., Pruessner, M., et al.[2019]

Introducing a vocational specialist using the individual placement and support (IPS) model significantly reduced unemployment rates from 75% to 62% in young people with psychosis over a 12-month period.

The positive impact on employment was lost after the vocational specialist was withdrawn, highlighting the importance of ongoing support for improving occupational functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving vocational outcomes of service users in an Early Intervention in Psychosis service. Dudley, R., Nicholson, M., Stott, P., et al.[2014]

The NAVIGATE model for early psychosis intervention (EPI) includes four key components: individualized medication management, resiliency training, supported employment and education, and family education, aiming to improve recovery-based care in Ontario, Canada.

This study will evaluate the implementation of NAVIGATE across multiple sites with 400 participants over 2 years, focusing on fidelity to the EPI model and individual and system-level outcomes, while actively involving individuals with lived experience in the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults. Kozloff, N., Foussias, G., Durbin, J., et al.[2021]

A quality improvement collaborative in the Netherlands successfully implemented three interventions (individual placement and support, cognitive remediation, and shared decision making) for 332 patients with early psychosis over 24 months, achieving moderate-to-high fidelity scores for these interventions.

Despite the successful implementation, the uptake and availability of these interventions showed mixed results, suggesting that a multifaceted approach and careful testing phases are essential for effective integration into services for vocational recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Evidence-Based Interventions to Improve Vocational Recovery in Early Psychosis: A Quality-Improvement Report. van Duin, D., van Wamel, A., de Winter, L., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-mental-disorders-10-2021-c6c45

InVEST Program for High Risk for Psychosis (InVEST Trial) What data supports the effectiveness of the InVEST treatment for high risk for psychosis? Research shows that similar programs, like Supported Employment ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34309187/

Individualized vocational and educational support and ... Research demonstrates that clinical high risk for psychosis (CHR-p) populations experience impairments in role functioning. Although several ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05114733

Study Details | NCT05114733 | Individualized Vocational ... Our secondary outcome is role functioning. Official Title. Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis ( ...

4. reporter.nih.gov reporter.nih.gov/project-details/10640940

InVEST: Individualized Vocational and Educational Support and ... InVEST is a novel intervention for a prioritized treatment outcome (i.e., role functioning) in a high-risk population, and is distinct from other empirically ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/eip.13186

Individualized vocational and educational support and ... Research demonstrates that clinical high risk for psychosis (CHR-p) populations experience impairments in role functioning. Although several ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8799684/

Public health primary prevention implemented by clinical high ... Clinical High Risk for Psychosis (CHR-P) services have been primarily developed to support young people with attenuated symptoms (indicated ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/eip.13408

Sessions Abstracts - 2023 - Early Intervention in Psychiatry Methods: Individuals aged 15–65 years with clinically established ultra-high risk or first episode of psychosis were randomly assigned to TAU or ...

8. hse.ie hse.ie/eng/about/who/cspd/ncps/mental-health/psychosis/resources/hse-early-intervention-in-psychosis-model-of-care-june-20191.pdf

hse-early-intervention-in-psychosis-model-of-care-june- ... Revision Date: The HSE Mental Health National Clinical Programme for Early. Intervention in Psychosis will be reviewed in 2022, unless the need for revision is.

9. ochealthinfo.com ochealthinfo.com/sites/healthcare/files/2023-06/MHSA_2023-26_Plan_Low_Res_v02.pdf

Orange County - Mental Health Services Act ... program being transitioned from Innovation and sustained in PEI. Working with OC CREW, offers a continuum of specialized services for psychosis ...