Clinical trial NCT05578066: Reducing Stigma Toward Mental Illness and Substance Use Issues in Primary Health Care in Chile
Official title: Reducing Stigma Toward Mental Illness and Substance Use Issues in Primary Health Care in Chile: A Cluster Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Substance Abuse
Stigmatization
Keywords: Primary Health Care
Implementation science
social stigma
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2022-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm, cluster-randomized controlled trial with CESFAMs being the unit of randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survey for PHC Providers (Scale 1 - main scale)
timeFrame: 2 years
measure: Survey for PHC Providers (Scale 2)
timeFrame: 2 years
measure: Survey for PHC Providers (Scale 3)
timeFrame: 2 years
measure: Survey for PHC Providers (Scale 4)
timeFrame: 2 years
measure: Survey for PHC Users
timeFrame: 2 years
measure: Identify critical barriers and opportunities for its implementation in PHC
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Cesfam Chuchunco
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Jaime C Sapag, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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