Reducing Stigma Toward Mental Illness and Substance Use Issues in Primary Health Care in Chile

October 9, 2022 updated by: Pontificia Universidad Catolica de Chile

Reducing Stigma Toward Mental Illness and Substance Use Issues in Primary Health Care in Chile: A Cluster Randomized Control Trial.

This research project aims to determine the effectiveness of a comprehensive anti-stigma intervention in reducing stigmatizing attitudes and behaviours among Primary Health Care (PHC) providers toward individuals with mental illness and/or substance use issues (MISUI) in the Chilean context, using Centros de de Salud Familiar (CESFAMs) as the point of intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The intervention model will be culturally adapted with CESFAM PHC provider and user input to be relevant and valid to Chile. The 18-month intervention includes five (5) components that are simultaneously implemented in CESFAMs: (1) Develop a Team of Local Champions in each intervention CESFAM, comprising PHC providers and users; (2) Analysis of Internal CESFAM Policies, Procedures, and Protocols to determine areas of improvement in service delivery for individuals with MISUI; (3) Raising Awareness of stigma toward MISUI using various forms of media within the CESFAM; (4) Innovative Contact-Based Education workshops on anti-stigma and recovery principles, co-lead by academic/clinical trainers and a person with lived experience of MISUI; and (5) Recovery-Based Arts, a multi-week arts workshop for PHC providers and users to produce artwork related to MISUI and recovery, culminating in an exhibition to showcase artwork for the CESFAM providers, users, and community.

Due to Coronavirus disease of 2019 (COVID-19) sanitary context some of the interventions may be developed remotly dependind on each primary healthcare center needs and capability. This interventions will be implemented in years two and three of the study and the final year of the study is dedicated to integrated data analysis, a 6-month follow-up data collection, and dissemination of results.

If the intervention proves to be effective, control CESFAMs will be provided with an anti-stigma initial training and protocols for intervention implementation.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jaime C Sapag, Phd
  • Phone Number: +56988034628
  • Email: jsapag@uc.cl

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Cesfam Chuchunco
        • Contact:
          • Ximena Morlans, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CESFAM must serve a registered population of at least 15,000 people
  • CESFAM have at least 50 staff employed

Exclusion Criteria:

  • CESFAM being part of another antistigma program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

The experimental group will be composed by aproximately 8 CESFAM with 36 Primary Health Care providers that are currently employed with a total of 288 providers per arm. And some PHC users that have received care there for Mental Health Abuse Issues in the three months prior to study participation.

The interventions include a comprehensive, 18-month, recovery-oriented anti-stigma intervention is composed by five components.

  1. Developing a Team of Local Champions
  2. Analysis of Internal Policies, Procedures and Protocols
  3. Raising Awareness
  4. Innovative Contact-Based Education
  5. Recovery based Arts.

Teams of leaders developed as part of the first component will assist the research team with the implementation of the anti-stigma intervention at their respective CESFAM.
Other: Developing teams of Local Leaders
A team of local leaders, consisting of 3-5 PHC providers and 1-2 users at each CESFAM will be developed in months 1-3 of the intervention.The teams will comprise some individuals who have provided critical support and input, including participating in the exploratory research phase and the Community-Based Participatory Research (CBPR) adaptation of the intervention framework for the Chilean context developed previously. The teams will assist with the data collection process throughout the study by encouraging colleagues to complete questionnaires and recruit users, as well as oversee and implement the intervention at their respective CESFAM. They will receive training to develop their skills as leaders and support the implementation process at their respective CESFAM.
Other: Analysis of Internal Policies, Procedures and Protocols
This component involves evaluating CESFAM policies, procedures, and protocols using an anti-stigma/pro-recovery approach to identify strengths and areas for improvement in service delivery for individuals affected by MISUI. This will be completed using a policy analysis tool based on existing frameworks, such as the Health Equity Impact Assessment Tool (PHO & OMHLTC, 2012) and the QualityRights Toolkit (WHO, 2012). At least 5 policies, procedures, or protocols to be analyzed will be selected by the local leaders at intervention CESFAM during months 3-6 of the intervention. Recommendations concerning health equity, prevention of stigma, and promotion of recoveryoriented practices for individuals with MISUI will be developed and shared following analysis. Each intervention CESFAM will be expected to implement at least one recommendation and make the necessary efforts to educate PHC providers about the policy change in months 7-18 of the intervention.
Other: Raising Awareness
Various forms of media will be used to raise awareness about stigma related to MISUI among PHC providers and users. Local leaders at intervention CESFAM will determine the type of media they would like to use; this may include images, film, music, or a combination of media. The research team will work with local leaders to develop messaging to include in the media and assist with showcasing these pieces within each intervention CESFAM. This component will be implemented throughout the intervention (intervention months 1-18). Depending on the type of media, instances of use will be tracked accordingly. For example with posters, data on the number of posters posted at a CESFAM over what time period and an estimation of the number of PHC providers and users who have viewed the posters will be collected.
Other: Innovative Contact-Based Education
Educational workshops will include anti-stigma and recovery principles, along with specific MISUI topics relevant to PHC providers. This will be determined by findings from the exploratory phase, current research, best practices, and the perspectives of local leaders. It may include (1) supporting CESFAM PHC providers in preventing stigma and promoting recovery in their practice and (2) enhancing the competencies of CESFAM PHC providers for discussing MISUI with their users, identifying MISUI signs and symptoms, and referring users to psychosocial centres for treatment. The key feature of these workshops is the contact-based educational element, where people with lived experience participate in developing and delivering the curriculum to CESFAM PHC providers. Four three-hour workshops will be held at each intervention CESFAM and will be facilitated by two academic/clinical trainers with expertise in stigma research and practice, and one person with lived experience.
Other: Recovery-Based Arts
Local leaders at CESFAM will select one PHC provider member and recruit one artist to develop an arts curriculum and facilitate the art sessions. The facilitators will select an art form to use throughout the sessions, and in collaboration with local leaders they will determine themes related to MISUI to cover in each session (planning process will be completed in intervention months 7-8). Arts workshops will be held for 10 weeks, with each session lasting up to three hours (during intervention months 9-12). Ten users affected by MISUI and at least three CESFAM PHC providers will participate in the workshops each week. At the end of the 10-week program, each CESFAM will host an exhibition to showcase the artwork that has been produced (during intervention months 13-18). All PHC providers and users, as well as community members, will be invited to attend the exhibition. PHC providers and users will be invited to speak about their experiences learning and working together to create art.
No Intervention: Control group

The control group will be composed by aproximately 8 CESFAM with 36 Primary Health Care providers that are currently employed with a total of 288 providers per arm. And some PHC users that have received care there for Mental Health Abuse Issues in the three months prior to study participation.

Data will be collected from this group in order to generate an integrated analysis with the information recolected from the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey for PHC Providers (Scale 1 - main scale)
Time Frame: 2 years

A self-administered questionnaire will be used to examine stigma directed at persons with MISUI among health professionals. This questionnaire will be completed at four time-points (baseline, mid-point, end-point, and 6-month follow-up). It will collect data related to two main components: (1) socio-demographic and other relevant general variables (see Appendix 1.10 for variables); and (2) attitudes toward MISUI stigma and recovery. The end-point questionnaire will also include a third component focusing on the intervention and its implementation.

The main scale to measure stigma toward MISUI to include in the questionnaire is the Opening Minds Scale for Health Care Providers (OMS-HC6). This 20-item instrument can result in a possible score of 20 to 100, with a higher score indicating more stigmatizing attitudes and behavioral intentions. Some items in the scale require reverse coding. There is also a 15-item version.

In addition, complementing, four other scales are considered.
2 years
Survey for PHC Providers (Scale 2)
Time Frame: 2 years
Mental Illness: Clinicians' Attitudes (MICA 7; overall scores range from a minimum of 16 to a maximum of 96, with higher scores indicating more stigmatizing and negative attitudes toward mental illness).
2 years
Survey for PHC Providers (Scale 3)
Time Frame: 2 years
Modified Bogardus Social Distance Scale (scores from 9 to 36, higher scores represent greater social distance) or Grandon Social Distance Scale (scores from 5 to 25, higher scores represent less social distance)
2 years
Survey for PHC Providers (Scale 4)
Time Frame: 2 years
Recovery Assessment Scale for Providers (Score range: 13 -least negative attitudes toward recovery- to 117 -most negative attitudes regarding recovery-).
2 years
Survey for PHC Users
Time Frame: 2 years
A face-to-face survey assisted by a research team member be used to examine how users perceive stigmatizing attitudes and behaviours among CESFAM PHC providers. The questionnaire will include four main components: (1) socio-demographic and other relevant general variables; (2) perceived stigmatizing attitudes and behaviours among CESFAM PHC providers; (3) perceived recovery-oriented practices by CESFAM PHC providers; and (4) accessing healthcare at their CESFAM. The questionnaire will take approximately 30 minutes to complete. The Perceived Devaluation-Discrimination Scale will be used to assess the extent to which users believe that other people devalue or discriminate against someone with MISUI. And adapted version of the Discrimination Experience Subscale of the 29-item Internalized Stigma of Mental Illness (ISMI).
2 years
Identify critical barriers and opportunities for its implementation in PHC
Time Frame: 2 years

To evaluate implementation of the intervention, qualitative interviews will be held with two PHC providers (local champions) and one CESFAM authority per intervention site at baseline, mid-point, and end-point. In addition, at least one local champion from the community will be interviewed to explore his/her experience as a leader, pros and cons of the intervention and how it could be improved. Questions will relate to implementation outcomes for the intervention: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage and sustainability.

The Consolidated Framework for Implementation Research (CFIR) will be considered to guide the process.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

University of Chile

Investigators

  • Principal Investigator: Jaime C Sapag, Phd, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

October 9, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDECYT 1201504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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