InVEST Program for High Risk for Psychosis

(InVEST Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Michelle Friedman-Yakoobian, PHD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Full psychosis diagnosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the efficacy of InVEST (Individualized Vocational and Educational Support and Training) for CHR-P (clinical high risk for psychosis) to address specific role functioning difficulties associated with the CHR-P phase. Our specific goals are: 1. Part 1: Preliminary open trial of InVEST (n = 8) to collect preliminary feasibility and acceptability data by providing the intervention, administering assessments, and collecting focus group and self-report feedback from open trial participants. The open trial phase will help to refine recruitment approaches and to modify the treatment manual as needed. 2. Part 2: Preliminary randomized controlled trial of InVEST vs. Delayed InVEST (DI) to explore preliminary evidence of efficacy of InVEST vs. DI (n = 30). The investigators hope to gain understanding of the feasibility of InVEST and the study's assessment procedures, and to gain a preliminary understanding of the intervention's efficacy for functioning difficulties experienced by young people at CHR-P.

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 data supports the effectiveness of the InVEST treatment for high risk for psychosis?

Research shows that similar programs, like Supported Employment and Education (SEE) using the Individual Placement and Support (IPS) model, improve educational and vocational outcomes for people with early psychosis, suggesting that InVEST could have similar benefits. ^{1 2 3 4 5}

Is the InVEST Program for High Risk for Psychosis safe for humans?

The research articles do not provide specific safety data for the InVEST Program or its related interventions, but they do mention that early psychosis intervention programs, which include components like supported employment and education, are widely implemented and recommended in guidelines, suggesting a general acceptance of their safety in practice. ^{1 4 5 6 7}

How is the InVEST treatment different from other treatments for high risk for psychosis?

The InVEST treatment is unique because it focuses on individualized vocational and educational support, specifically targeting educational and employment recovery for those at high risk for psychosis, unlike most treatments that primarily address symptom management and relapse prevention. ^{1 2 5 8 9}

Research Team

Michelle Friedman-Yakoobian, PHD

Principal Investigator

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

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• InVEST (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Personnel time required for supported employment and education services for individuals in a recent-onset psychosis treatment program. [2022]

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

Improving vocational outcomes of service users in an Early Intervention in Psychosis service. [2014]

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

Implementing Evidence-Based Interventions to Improve Vocational Recovery in Early Psychosis: A Quality-Improvement Report. [2021]

4. Australia 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? [2019]

5. England 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. [2023]

6. England 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. [2021]

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

Establishing a clinical service to prevent psychosis: What, how and when? Systematic review. [2023]

8. United States 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. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

[Early Detection and Intervention for Psychosis: Why and How?] [2022]