Clinical trial NCT05057026: Impact of a Mental Health Support Program on of Medical Residents' Stigmatization Towards People With Lived Experience
Official title: Impact of a Mental Health Support Program on Stigmatization and Confidence of Medical Residents Working With People With Mental Health Concerns
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression, Anxiety Disorders
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2021-09-27
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents from the University of Dalhousie family medicine residency program providing care for people with mental health conditions

Brief summary: The program, called the Mental Health Practice Support Program, is designed to teach new tools and skills for working with patients with mental health concerns in a family practice setting. The program is also being evaluated for effectiveness.

Detailed description: Description of the Intervention

The Adult Mental Health Practice Support Program (PSP) was designed in 2009 by the General Practice Services Committee (GPSC) (a joint initiative of the BC Medical Association and the BC Ministry of Health) to address needs expressed by the province's family physicians to improve patient care in British Colombia. Its content and delivery model has been designed using evidence-based key ingredients and implication factors understood to be important for effective stigma reduction. These include the following:

* the use of contact-based education, a well-established best practice to reduce stigma where patients share their story with a focus on recovery, showing that recovery is not only possible but the goal;
* skills-building to increase confidence and provide another management option with or without drugs particularly if access to mental health support services is difficult or absent;
* tools - using the principles of cognitive behavioural theory -- than can be flexibly used within constraints of a busy practice reflecting a "real world" scenario;
* provider-patient shared responsibility in decision-making, patient engagement in recovery process
* practical practice support throughout the training period. The AMHPSP program has been implemented and evaluated with practicing primary care practitioners in numerous jurisdictions with positive results.

The program introduces learners to an organized approach to mental health treatment, starting from a problem and strength-based assessment through to the development of an action plan, which, using flow charts, providers can negotiate user-friendly CBT-based self-management options tailored to patient needs. These tools can be delivered within office time constraints, reflecting a "real world" scenario. One of the many tools is the AMHPSP algorithm, which houses all program tools and can be saved on a desktop for easy access at the click of a button (e.g., several validated screening scales for mental illnesses commonly seen in primary care, perinatal screening tools, medication algorithm, useful referral forms etc.) in addition to the three main supported self-management strategies described below:

* The Cognitive Behavioral Interpersonal Skills workbook (CBIS) The CBIS manual includes three main assessment tools: 1) the Diagnostic Assessment Interview; 2) the Problem List, Problem List Action Plan, and Resource list; and 3) the SAQ self-assessment questionnaires, all of which engage patient participation.
* The BounceBack program led by the Canadian Mental Health Association consists of a telephone delivered provincially funded evidence-based skills program designed to help adults experiencing symptoms of mild to moderate depression, low mood, or stress, with or without anxiety. Mental health coaches will work with patients usually every 1-2 weeks. The service operates at arm's length of HCPs all the while sending providers essential information on diagnosis and care course trajectory.

The primary thrust of the program is that all tools are meant to help build a shared responsibility model with the patient by increasing patient-provider interaction, negotiation, and partnership. Patients are encouraged to take an active role in the management of the problems most relevant to them, which in the end engages them in their recovery effort.

While previous implementations of the PSP program were delivered in-person, the adapted version for medical residents will be delivered virtually, to accommodate for any additional possible disruptions that may be brought about the ongoing COVID-10 pandemic.

Research Question and Objectives

The objective of the research is to assess the extent to which the adapted PSP program is effective at increasing residents' confidence and comfort in working with patients with mental health concerns; and decreasing stigmatizing attitudes, including the preference for social distance. Specific research questions are as follows:

The investigators hypothesize that enhanced skills in program participants will lead to increased comfort on the part of the medical residents, diminished preference for social distance, and improved attitudes and emotional responses towards patients with mental illnesses.

Methods The research is an intervention study, using a longitudinal pre-post-follow up design.

The intervention will be delivered virtually over a total of 4 sessions, covering an 8-week period. Each training session will take place approximately two weeks apart and will be two hours in length. A Practice Support Coordinator will support the "action period" work of the residents in between each of the training sessions. A two hour virtually delivered booster session will be provided to students approximately one year after the delivery of the initial training.

Outcomes of Interest

The investigators have identified two primary outcomes, which are as follows:

* Reduction in stigmatizing attitudes and behaviors from pre to post intervention, including preference for social distance, attitudes, and emotional responses toward patients with a mental illness.
* Improvements in confidence and comfort working with patients with mental health concerns from pre to post intervention.

Secondary outcomes are:

* Confidence and comfort in the use of tools/strategies.
* Impact of the program on emotional responses to interactions with patients with mental illnesses.

Our exploratory outcome of interest is an examination of the correlation between changes in stigma and changes in comfort or confidence.

The investigators will examine changes in mean scores across the different time points, using paired t-tests. A clinically meaningful outcome is considered as an improvement of 10% on the OMS-HC from pre to post training, which is slightly higher than the score change observed in a previous large scale RCT study of the PSP program with practicing physicians in Nova Scotia. Our calculations indicate that a sample of 26 residents will be required. Under this assumption, 80% power would be achieved to detect this difference with an alpha value of 5%.

A report on the results of the study will be compiled, with the intention that findings are publishable in the peer reviewed literature. Study findings will also be presented at academic conferences.

Eligibility criteria: Inclusion Criteria:

* Family Medicine residency program students in the1st year of their program.
* Provision of informed consent In good standing in their program.

Exclusion Criteria:

• Medical Students who are not enrolled in Dalhousie University Family Medicine residency program

Primary outcomes:
measure: Opening Minds Scale for Health Providers (OMS-HC)
timeFrame: Pre-training, post-training, 6 , 12 and 18 months post -training
measure: PSP resident study_survey v1F Comfort in Managing Mental Health Conditions
timeFrame: Pre-training, post-training, 6 , 12 and 18 months post -training
Secondary outcomes:
measure: Emotion Scale
timeFrame: Pre-training, post-training, 6 , 12 and 18 months post -training
measure: PSP resident study_survey v1F Use of and Comfort in Use of Tools and Strategies of the Program
timeFrame: Pre-training, post-training, 6 , 12 and 18 months post -training
Other outcomes:
measure: Correlation between changes in Physician Confidence and Stigma Scores.
timeFrame: Pre-training, post-training, 6 , 12 and 18 months post -training
Locations:
city: Halifax
country: Canada
facility: Dalhousie University Department of Psychiatry
state: Nova Scotia
Study officials:
affiliation: Dalhousie University Department of Psychiatry
name: Bianca Lauria-Horner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adshead, Gwen. 2005. Healing ourselves: ethical issues in the care of sick doctors. Advances in Psychiatric Treatment 11 (5): 330-37. https://doi.org/10.1192/apt.11.5.330.
citation: Azrin ST. Integrated care: High-impact mental health-primary care research for patients with multiple comorbidities. Psychiatr Serv. 2014 Apr 1;65(4):406-9. doi: 10.1176/appi.ps.201300537.
citation: Beaulieu T, Patten S, Knaak S, Weinerman R, Campbell H, Lauria-Horner B. Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial. Can J Psychiatry. 2017 May;62(5):327-335. doi: 10.1177/0706743716686919. Epub 2017 Jan 17.
citation: Caldwell TM, Jorm AF. Mental health nurses' beliefs about likely outcomes for people with schizophrenia or depression: a comparison with the public and other healthcare professionals. Aust N Z J Ment Health Nurs. 2001 Mar;10(1):42-54. doi: 10.1046/j.1440-0979.2001.00190.x.
citation: Health Nursing 10 (1): 42-54. https://doi.org/10.1046/j.1440-0979.2001.00190.x. College of Family Physicians of Canada, Canadian Psychiatric Association, and Canadian Psychological Association. (2020). Integrating Mental Health Services in Primary Care. Ontario: College of Family Physicians of Canada, Canadian Psychiatric Association, and Canadian Psychological Association.
citation: Corrigan P. How stigma interferes with mental health care. Am Psychol. 2004 Oct;59(7):614-625. doi: 10.1037/0003-066X.59.7.614.
citation: Emrich K, Thompson TC, Moore G. Positive attitude. An essential element for effective care of people with mental illnesses. J Psychosoc Nurs Ment Health Serv. 2003 May;41(5):18-25. doi: 10.3928/0279-3695-20030501-09.
citation: Jones S, Howard L, Thornicroft G. 'Diagnostic overshadowing': worse physical health care for people with mental illness. Acta Psychiatr Scand. 2008 Sep;118(3):169-71. doi: 10.1111/j.1600-0447.2008.01211.x. No abstract available.
citation: Knaak S, Mantler E, Szeto A. Mental illness-related stigma in healthcare: Barriers to access and care and evidence-based solutions. Healthc Manage Forum. 2017 Mar;30(2):111-116. doi: 10.1177/0840470416679413. Epub 2017 Feb 16.
citation: Knaak S, Modgill G, Patten SB. Key ingredients of anti-stigma programs for health care providers: a data synthesis of evaluative studies. Can J Psychiatry. 2014 Oct;59(10 Suppl 1):S19-26. doi: 10.1177/070674371405901s06.
citation: Knaak S, Patten S. A grounded theory model for reducing stigma in health professionals in Canada. Acta Psychiatr Scand. 2016 Aug;134 Suppl 446:53-62. doi: 10.1111/acps.12612.
citation: Kopera M, Suszek H, Bonar E, Myszka M, Gmaj B, Ilgen M, Wojnar M. Evaluating Explicit and Implicit Stigma of Mental Illness in Mental Health Professionals and Medical Students. Community Ment Health J. 2015 Jul;51(5):628-34. doi: 10.1007/s10597-014-9796-6. Epub 2014 Dec 23.
citation: Lauria-Horner B, Beaulieu T, Knaak S, Weinerman R, Campbell H, Patten S. Controlled trial of the impact of a BC adult mental health practice support program (AMHPSP) on primary health care professionals' management of depression. BMC Fam Pract. 2018 Nov 28;19(1):183. doi: 10.1186/s12875-018-0862-y.
citation: Lukovic JA, Miletic V, Pekmezovic T, Trajkovic G, Ratkovic N, Aleksic D, Grgurevic A. Self-medication practices and risk factors for self-medication among medical students in Belgrade, Serbia. PLoS One. 2014 Dec 11;9(12):e114644. doi: 10.1371/journal.pone.0114644. eCollection 2014.
citation: MacCarthy D, Weinerman R, Kallstrom L, Kadlec H, Hollander MJ, Patten S. Mental health practice and attitudes of family physicians can be changed! Perm J. 2013 Summer;17(3):14-7. doi: 10.7812/TPP/13-033.
citation: Modgill G, Patten SB, Knaak S, Kassam A, Szeto AC. Opening Minds Stigma Scale for Health Care Providers (OMS-HC): examination of psychometric properties and responsiveness. BMC Psychiatry. 2014 Apr 23;14:120. doi: 10.1186/1471-244X-14-120.
citation: 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.
citation: Patten SB, Remillard A, Phillips L, Modgill G, Szeto ACh, Kassam A, Gardner DM. Effectiveness of contact-based education for reducing mental illness-related stigma in pharmacy students. BMC Med Educ. 2012 Dec 5;12:120. doi: 10.1186/1472-6920-12-120.
citation: Schwenk TL, Davis L, Wimsatt LA. Depression, stigma, and suicidal ideation in medical students. JAMA. 2010 Sep 15;304(11):1181-90. doi: 10.1001/jama.2010.1300.
citation: Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.
citation: Ungar T, Knaak S, Szeto AC. Theoretical and Practical Considerations for Combating Mental Illness Stigma in Health Care. Community Ment Health J. 2016 Apr;52(3):262-71. doi: 10.1007/s10597-015-9910-4. Epub 2015 Jul 15.
citation: Wallace JE. Mental health and stigma in the medical profession. Health (London). 2012 Jan;16(1):3-18. doi: 10.1177/1363459310371080. Epub 2010 Dec 22.
citation: Weinerman R, Campbell H, Miller M, Stretch J, Kallstrom L, Kadlec H, Hollander M. Improving mental healthcare by primary care physicians in British Columbia. Healthc Q. 2011;14(1):36-8. doi: 10.12927/hcq.2011.22146.
citation: MacCarthy D, Kallstrom L, Kadlec H, Hollander M. Improving primary care in British Columbia, Canada: evaluation of a peer-to-peer continuing education program for family physicians. BMC Med Educ. 2012 Nov 9;12:110. doi: 10.1186/1472-6920-12-110.