Individual Placement and Support for Mental Illness

(IPS Trial)

Recruiting 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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Hothe investigatorsver, not a single country in Latin America offers IPS services. In addition, services to support employment and education tend to be ad hoc, low-intensity, and not the investigatorsll evaluated because most clinicians are not trained in evidence-based practices. Clinicians are not trained in evidence-based approaches and do not provide high-fidelity services. The overall goal of this project is to pilot the IPS for PSMI in the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco, Mexico. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=\~5,000). This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere. The investigators will use the Dynamic Adaptation Process model to first inform the adaptation of IPS in Mexico, using our previous experience adapting IPS and deep understanding of the local context (e.g., the nature of the labor market in Mexico) to inform the adaptations. The investigators will then evaluate the implementation and impact of the adapted IPS in a pilot RCT (N = 120). This pilot RCT will Include quantitative and qualitative assessments at baseline, 6 months, and 12 months with clients, providers, and other key stakeholders. The investigators aim to refine implementation processes, understand outcomes and tools, and estimate pothe investigatorsr for a future regional trial in Latin America.

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 data supports the effectiveness of the treatment Individual Placement and Support (IPS) for mental illness?

Research shows that Individual Placement and Support (IPS) is an effective approach to help people with severe mental illness find and keep jobs. Studies highlight its success in supporting competitive employment and improving recovery outcomes for individuals with mental disorders. ^{1 2 3 4 5}

Is Individual Placement and Support (IPS) safe for people with mental illness?

There is no specific safety data available for Individual Placement and Support (IPS) in the provided research articles. However, these articles discuss general safety concerns in mental health settings, highlighting the importance of monitoring and improving patient safety. ^{6 7 8 9 10}

How is the Individual Placement and Support (IPS) treatment different from other treatments for mental illness?

Individual Placement and Support (IPS) is unique because it focuses on helping people with serious mental illness find and keep competitive jobs in regular work settings, emphasizing personal preferences and rapid job placement. Unlike other treatments, IPS integrates employment specialists into mental health teams and provides ongoing support tailored to each individual's needs. ^{1 3 4 5 11}

Research Team

JESUS A. ALDANA LOPEZ, MPH

Principal Investigator

Jalisco Institute of Mental Health (SALME)

Eligibility Criteria

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 provided your informed consent to participate.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Vocational support in mental health service delivery in Australia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Who benefits from individual placement and support? A meta-analysis. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The contribution of IPS to recovery from serious mental illness: a case study. [2009]

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

Individual Placement and Support: a community mental health center approach to vocational rehabilitation. [2019]

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

An update on randomized controlled trials of evidence-based supported employment. [2019]

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

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

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

Developing and Aligning a Safety Event Taxonomy for Inpatient Psychiatry. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[Patient safety in psychiatric hospitalization - What incidents are reported and managed?] [2019]

9. England pubmed.ncbi.nlm.nih.gov

Mental health nurses experience of the introduction and practice of the Safewards model: a qualitative descriptive study. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Survey on critical incident reporting in a child and adolescent mental health service. [2013]

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

Update on funding IPS supported employment services in the IPS learning community. [2022]