NCT05578066

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 13, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

May 11, 2022

Last Update Submit

October 9, 2022

Conditions

Keywords

Primary Health CareImplementation sciencesocial stigma

Outcome Measures

Primary Outcomes (6)

  • Survey for PHC Providers (Scale 1 - main scale)

    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)

    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)

    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)

    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

    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

    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

Study Arms (2)

Intervention group

EXPERIMENTAL

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 LeadersOther: Analysis of Internal Policies, Procedures and ProtocolsOther: Raising AwarenessOther: Innovative Contact-Based EducationOther: Recovery-Based Arts

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

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.

Intervention group

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.

Intervention group

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.

Intervention group

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • CESFAM being part of another antistigma program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cesfam Chuchunco

Santiago, Chile

RECRUITING

Related Publications (22)

  • Parra Videla C, Sapag JC, Klabunde R, Velasco PR, Anriquez S, Aracena Alvarez M, Mascayano F, Bravo P, Sena BF, Jofre Escalona A, Bobbili SJ, Corrigan PW, Bustamante I, Poblete F, Alvarado R. Cross-cultural adaptation of four instruments to measure stigma towards people with mental illness and substance use problems among primary care professionals in Chile. Transcult Psychiatry. 2023 Apr;60(2):286-301. doi: 10.1177/13634615221100377. Epub 2022 Jul 12.

    PMID: 35821607BACKGROUND
  • Kassam A, Papish A, Modgill G, Patten S. The development and psychometric properties of a new scale to measure mental illness related stigma by health care providers: the Opening Minds Scale for Health Care Providers (OMS-HC). BMC Psychiatry. 2012 Jun 13;12:62. doi: 10.1186/1471-244X-12-62.

    PMID: 22694771BACKGROUND
  • Khenti A, Mann R, Sapag JC, Bobbili SJ, Lentinello EK, Maas MV, Agic B, Hamilton H, Stuart H, Patten S, Sanches M, Corrigan P. Protocol: a cluster randomised control trial study exploring stigmatisation and recovery-based perspectives regarding mental illness and substance use problems among primary healthcare providers across Toronto, Ontario. BMJ Open. 2017 Nov 20;7(11):e017044. doi: 10.1136/bmjopen-2017-017044.

    PMID: 29162572BACKGROUND
  • Murney MA, Sapag JC, Bobbili SJ, Khenti A. Stigma and discrimination related to mental health and substance use issues in primary health care in Toronto, Canada: a qualitative study. Int J Qual Stud Health Well-being. 2020 Dec;15(1):1744926. doi: 10.1080/17482631.2020.1744926.

    PMID: 32228393BACKGROUND
  • Khenti A, Bobbili SJ, Sapag JC. Evaluation of a Pilot Intervention to Reduce Mental Health and Addiction Stigma in Primary Care Settings. J Community Health. 2019 Dec;44(6):1204-1213. doi: 10.1007/s10900-019-00706-w.

    PMID: 31317439BACKGROUND
  • Khenti A, Thomas FC, Mohamoud S, Diaz P, Vaccarino O, Dunbar K, Sapag JC. Mental health and addictions capacity building for community health centres in Ontario. Can Fam Physician. 2017 Oct;63(10):e416-e424.

    PMID: 29025818BACKGROUND
  • Sapag JC, Sena BF, Bustamante IV, Bobbili SJ, Velasco PR, Mascayano F, Alvarado R, Khenti A. Stigma towards mental illness and substance use issues in primary health care: Challenges and opportunities for Latin America. Glob Public Health. 2018 Oct;13(10):1468-1480. doi: 10.1080/17441692.2017.1356347. Epub 2017 Aug 2.

    PMID: 28766377BACKGROUND
  • van der Maas M, Stuart H, Patten SB, Lentinello EK, Bobbili SJ, Mann RE, Hamilton HA, Sapag JC, Corrigan P, Khenti A. Examining the Application of the Opening Minds Survey in the Community Health Centre Setting. Can J Psychiatry. 2018 Jan;63(1):30-36. doi: 10.1177/0706743717719079. Epub 2017 Jun 30.

    PMID: 28665144BACKGROUND
  • Mascayano F, Toso-Salman J, Ho YCS, Dev S, Tapia T, Thornicroft G, Cabassa LJ, Khenti A, Sapag J, Bobbili SJ, Alvarado R, Yang LH, Susser E. Including culture in programs to reduce stigma toward people with mental disorders in low- and middle-income countries. Transcult Psychiatry. 2020 Feb;57(1):140-160. doi: 10.1177/1363461519890964. Epub 2019 Dec 19.

    PMID: 31856688BACKGROUND
  • Sapag JC, Velasco PR. [Stigma toward mental disorders and addictions: Study in Chilean primary care]. Aten Primaria. 2020 May;52(5):361-363. doi: 10.1016/j.aprim.2019.07.014. Epub 2019 Dec 9. No abstract available. Spanish.

    PMID: 31831205BACKGROUND
  • Sapag JC, Klabunde R, Villarroel L, Velasco PR, Alvarez C, Parra C, Bobbili SJ, Mascayano F, Bustamante I, Alvarado R, Corrigan P. Validation of the Opening Minds Scale and patterns of stigma in Chilean primary health care. PLoS One. 2019 Sep 5;14(9):e0221825. doi: 10.1371/journal.pone.0221825. eCollection 2019.

    PMID: 31487333BACKGROUND
  • Kemp CG, Jarrett BA, Kwon CS, Song L, Jette N, Sapag JC, Bass J, Murray L, Rao D, Baral S. Implementation science and stigma reduction interventions in low- and middle-income countries: a systematic review. BMC Med. 2019 Feb 15;17(1):6. doi: 10.1186/s12916-018-1237-x.

    PMID: 30764820BACKGROUND
  • Nyblade L, Stockton MA, Giger K, Bond V, Ekstrand ML, Lean RM, Mitchell EMH, Nelson RE, Sapag JC, Siraprapasiri T, Turan J, Wouters E. Stigma in health facilities: why it matters and how we can change it. BMC Med. 2019 Feb 15;17(1):25. doi: 10.1186/s12916-019-1256-2.

    PMID: 30764806BACKGROUND
  • Corrigan P, Schomerus G, Shuman V, Kraus D, Perlick D, Harnish A, Kulesza M, Kane-Willis K, Qin S, Smelson D. Developing a research agenda for understanding the stigma of addictions Part I: Lessons from the Mental Health Stigma Literature. Am J Addict. 2017 Jan;26(1):59-66. doi: 10.1111/ajad.12458. Epub 2016 Oct 25.

    PMID: 27779803BACKGROUND
  • Corrigan PW, Schomerus G, Shuman V, Kraus D, Perlick D, Harnish A, Kulesza M, Kane-Willis K, Qin S, Smelson D. Developing a research agenda for reducing the stigma of addictions, part II: Lessons from the mental health stigma literature. Am J Addict. 2017 Jan;26(1):67-74. doi: 10.1111/ajad.12436. Epub 2016 Nov 22.

    PMID: 27875626BACKGROUND
  • Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

    PMID: 19664226BACKGROUND
  • Gabbidon J, Clement S, van Nieuwenhuizen A, Kassam A, Brohan E, Norman I, Thornicroft G. Mental Illness: Clinicians' Attitudes (MICA) scale-psychometric properties of a version for healthcare students and professionals. Psychiatry Res. 2013 Mar 30;206(1):81-7. doi: 10.1016/j.psychres.2012.09.028. Epub 2012 Oct 16.

    PMID: 23084597BACKGROUND
  • Grandon P, Saldivia S, Vaccari P, Ramirez-Vielma R, Victoriano V, Zambrano C, Ortiz C, Cova F. An Integrative Program to Reduce Stigma in Primary Healthcare Workers Toward People With Diagnosis of Severe Mental Disorders: A Protocol for a Randomized Controlled Trial. Front Psychiatry. 2019 Mar 7;10:110. doi: 10.3389/fpsyt.2019.00110. eCollection 2019.

    PMID: 30899230BACKGROUND
  • Kates N, Arroll B, Currie E, Hanlon C, Gask L, Klasen H, Meadows G, Rukundo G, Sunderji N, Ruud T, Williams M. Improving collaboration between primary care and mental health services. World J Biol Psychiatry. 2019 Dec;20(10):748-765. doi: 10.1080/15622975.2018.1471218. Epub 2018 Jun 20.

    PMID: 29722600BACKGROUND
  • Pescosolido BA, Martin JK. The Stigma Complex. Annu Rev Sociol. 2015 Aug;41:87-116. doi: 10.1146/annurev-soc-071312-145702. Epub 2015 May 4.

    PMID: 26855471BACKGROUND
  • Moberg J, Kramer M. A brief history of the cluster randomised trial design. J R Soc Med. 2015 May;108(5):192-8. doi: 10.1177/0141076815582303. No abstract available.

    PMID: 26022551BACKGROUND
  • Sapag JC, Traub C, Velasco PR, Arratia T, Alvarado R, Aracena M, Poblete FC, Villarroel L, Bravo P, Alvarez-Huenchulaf C, Jofre Escalona A, Vargas-Malebran N, Bobbili S, Bustamante I, Khenti A, Corrigan PW. Reducing stigma toward mental illness and substance use issues in primary health care in Chile: Protocol of a cluster controlled trial study. Front Psychiatry. 2022 Dec 20;13:1083042. doi: 10.3389/fpsyt.2022.1083042. eCollection 2022.

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related DisordersStereotypingSocial Stigma

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental DisordersSocial Behavior

Study Officials

  • Jaime C Sapag, Phd

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime C Sapag, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A two-arm, cluster-randomized controlled trial with CESFAMs being the unit of randomization.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

October 13, 2022

Study Start

April 1, 2020

Primary Completion

July 31, 2024

Study Completion

March 31, 2025

Last Updated

October 13, 2022

Record last verified: 2022-05

Locations