Individual Placement and Support for Mental Illness

(IPS Trial)

Enrolling by invitation at 2 trial locations

Overseen By Alejandra Pérez De León, MPA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Disqualifiers: Age, Employment, Consent, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Individual Placement and Support (IPS) to assist people with mental illness in Jalisco, Mexico, in finding and maintaining competitive jobs. Researchers aim to determine if adapting this program to the local context can improve employment outcomes for participants. Participants will either receive the adapted IPS services or continue with the usual services offered at the clinic. Eligible individuals should have a mental illness, have been receiving services at CAISAME-EP for at least a month, and seek a paid job but have not held one in the past three months. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance employment support services in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on employment support rather than medication changes.

What prior data suggests that the Individual Placement and Support model is safe for people with mental illness?

Research has shown that the Individual Placement and Support (IPS) model is well-studied and considered safe. Studies have found that IPS services can significantly improve job opportunities for people with mental illness. Although specific safety data is not provided, IPS is a non-drug program that assists people in finding and keeping jobs. This method avoids medications or physical treatments, typically resulting in fewer side effects.

In clinical trials, researchers primarily test IPS for effectiveness rather than safety, as it is a supportive job service. No major safety issues have been reported in the studies mentioned. Given its established use and evidence of benefits, IPS is regarded as a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Individual Placement and Support (IPS) for mental illness because it offers a personalized, team-based approach that integrates employment support with mental health care. Unlike usual services, which may provide less intensive care due to shared resources with other conditions, IPS focuses exclusively on helping individuals with mental illness find and maintain employment through a coordinated effort among a team of specialists. This method ensures that clients receive consistent, individualized support, potentially leading to better outcomes in employment and mental health stability. IPS stands out by embedding employment specialists within the mental health treatment team, fostering ongoing collaboration and a seamless support experience for clients.

What is the effectiveness track record for the Individual Placement and Support (IPS) model in helping people with mental illness succeed in competitive employment?

Research has shown that the Individual Placement and Support (IPS) model, which participants in this trial may receive, effectively helps people with mental illness find jobs. Studies indicate that about two-thirds of people in IPS programs secure employment, more than twice the success rate of those not using IPS. A review of 17 studies found that people using IPS were 2.4 times more likely to find work than those using other services. IPS works well for various groups, including those with serious mental illnesses. It is a well-researched, evidence-based method that outperforms traditional services in helping people get jobs. ^{1 2 3 6 7}

Who Is on the Research Team?

JESUS A. ALDANA LOPEZ, MPH

Principal Investigator

Jalisco Institute of Mental Health (SALME)

Are You a Good Fit for This Trial?

This trial is for adults with mental illness in Jalisco, Mexico who want paid work but haven't had a job in the last 3 months. They must be getting help from CAISAME-EB, can't use other job services during the study, and need to have been to two info sessions before joining.

Inclusion Criteria

You are seeking paid, competitive employment.

You have been receiving services from CAISAME-EP for a minimum of one month.

You have attended two preceding instructional meetings before enlistment.

Exclusion Criteria

Are not willing to provide informed consent

I plan to continue seeking job-related services.

Are not receiving services from CAISAME-EP for at least one month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation and Training

Adaptation of the IPS model and training of the IPS teams

6 months

Implementation and Evaluation

Implementation of the adapted IPS model and evaluation through a pilot RCT

12 months

Baseline, 6-month, and 12-month assessments

Follow-up

Participants are monitored for outcomes such as employment and mental health functioning

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Individual Placement and Support (IPS)

Trial Overview The trial tests Individual Placement and Support (IPS), a program designed to help people with mental illness find and keep regular jobs. It's being adapted for Mexico and will include interviews and surveys over a year to see how well it works there.

How Is the Trial Designed?

Group I: Adapted IPS Experimental Treatment 1 Intervention

The IPS program adaptation process, will be conducted with 2 teams of providers, each consisting of an employment specialist, a case manager: psychologist, social worker and a psychiatrist, who will work in coordination to provide IPS services (each specialist will have between 15 and 20 clients). The IPS team will consist of providers and will be trained by the Research Adaptation Team in consultation and supervised. Weekly case-oriented supervision with a trained IPS supervisor, biweekly telephone contact, and telephone consultations as needed will help the IPS teams maintain high fidelity IPS. Following randomization, individuals assigned to receive IPS will be assigned to an IPS treatment team and will be introduced directly to their assigned case managers. Case management and IPS staff will be in close proximity to facilitate both IPS staff attendance at case management team meetings and the ongoing interaction necessary for efficient IPS implementation.

Group II: Usual Services. Active Control 1 Intervention

Generally, providers of rehabilitation Usual Care for PSMI at CAISAME-EP include 2 full-time psychologists, 2 full-time social workers, a half-time occupational therapist, and a half-time psychiatrist. This team, however, also provides services to clients with other mental conditions (e.g., substance use). As a result, the Usual Care services are of lower intensity than IPS and omit most of the key ingredients of the intervention. Moreover, it does not follow a standardized manual/protocol. The Usual Care team also offers other services such as psychiatric medication, individual and group psychotherapy, and psychoeducation for clients and relatives.

Individual Placement and Support (IPS) is already approved in United States, European Union for the following indications:

Approved in United States as IPS Supported Employment for:

• Serious Mental Illness
• Co-occurring Substance Use Disorders
• Veterans with Opioid Use Problems

Approved in European Union as Individual Placement and Support for:

• Serious Mental Illness
• Co-occurring Substance Use Disorders

Who Is Running the Clinical Trial?

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Lead Sponsor

Trials

15

Recruited

2,400+

Instituto Jalisciense de Salud Mental (SALME)

Collaborator

Trials

1

Recruited

120+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4417652/

Effectiveness of Individual Placement and Support Supported ... Overall, about two-thirds of IPS participants obtained competitive employment, more than twice the employment rate for those enrolled in ...

2. ipsworks.org ipsworks.org/index.php/evidence-for-ips/

Evidence for IPS A meta-analysis of 17 randomized controlled trials found that people receiving IPS services were 2.4 times more likely to be employed than controls.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11114326/

Individual placement and support: History, current status, and ... One meta‐analysis found that IPS was relatively more effective in subgroups of people with serious mental illness or schizophrenia spectrum ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524002018

Individual Placement and Support (IPS) beyond severe ... IPS services are consistently more effective in supporting diverse population groups into sustained employment compared to business-as-usual employment services ...

5. library.samhsa.gov library.samhsa.gov/product/individual-placement-and-support-ips-supported-employment-model/pep25-01-002

Individual Placement and Support (IPS) The IPS model of Supported Employment is grounded in research showing the transformative power of employment as a path to recovery.

6. nasmhpd.org nasmhpd.org/wp-content/uploads/2022-nasmhpd-ips-sed-whitepaper-508.pdf

Integrating Individual Placement and Support Model of ... IPS Supported Employment for young adults diagnosed with serious mental health conditions who either have not responded positively to IPS or who have very ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1936657424000013

Understanding interventions and outcomes in supported ... Two different SE fidelity scales exist: Individual Placement and Support (IPS) and the Supported Employment Quality Framework (SEQF). The IPS fidelity scale ...