Depression, Anxiety DisordersNCT05057026
Impact of a Mental Health Support Program on of Medical Residents' Stigmatization Towards People With Lived Experience
An observational study of Depression, Anxiety Disorders, run by Bianca Horner at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Training Program Adult Mental Health Practice Support Program
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2021to 10 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents from the University of Dalhousie family medicine residency program providing care for people with mental health conditions
Who may be able to join
- Family Medicine residency program students in the1st year of their program.
- Provision of informed consent In good standing in their program.
Who cannot join
- Medical Students who are not enrolled in Dalhousie University Family Medicine residency program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dalhousie University Department of Psychiatry
Halifax, Nova Scotia, B3H2E2
About this study
Official title: Impact of a Mental Health Support Program on Stigmatization and Confidence of Medical Residents Working With People With Mental Health Concerns
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.
Read the 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.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Training Program Adult Mental Health Practice Support Program
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Program Adult Mental Health Practice Support ProgramOther
The Adult Mental Health Practice Support Program (PSP) was designed in 2009 by the General Practice Services Committee (GPSC) 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,
- 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
The training will be delivered virtually over a total of 4 sessions two weeks apart, covering an 8-week period. A two hour virtually delivered booster session will be provided to students approximately one year after the delivery of the initial training.
| Study group | Role | What they receive |
|---|---|---|
| Adult mental health support program | The investigators will evaluate the Impact of an Adult mental health support program on stigmatization and confidence of medical residents working with people with mental health concerns. The intervention will be delivered to approximately 30 residents from the University of Dalhousie family medicine residency program from the 2021-2022 academic year. The training will be delivered by resident groups. The first group will receive the PSP training October - November 2022. The second will receive the training November 2021 to February 2022. The third will take the training March to May 2022. Each group will include approximately 10 residents. Receives: Other: Training Program Adult Mental Health Practice Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opening Minds Scale for Health Providers (OMS-HC)
Stigma changes will be measured using the 15 item Opening Minds Scale for Health Providers (OMS-HC), which captures providers' overall mental health related stigma as well as three main dimensions of stigma: negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Total scores can range from 15 to 75, with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. In 2014, a rigorous examination of the psychometric properties and responsiveness of the OMS-HC scale was conducted by Modgill G, et al. Results from this evaluation showed internal consistency as acceptable for all versions of the OMS scale (α = 0.74 to 0.79) and corresponding subscales (α = 0.67 to 0.68), further depicting the OMS-HC as an accurate and reliable instrument
Measured: Pre-training, post-training, 6 , 12 and 18 months post -training
PSP resident study_survey v1F Comfort in Managing Mental Health Conditions
Confidence in managing depression will be assessed using adaptations of measures used in previous evaluations of this program with practicing primary care physicians. Modified versions of three ad hoc scales developed for a randomized controlled evaluation study in Nova Scotia were used to collect demographic information. The scales were also used to assess levels of confidence on a number of statements pertaining to their ability to diagnose, treat, and otherwise manage patients' mental health concerns using a 7-point Likert scale (not at all, very low, low, moderate, high, very high), with higher scores indicating higher levels of confidence, comfort, and familiarity.
Measured: Pre-training, post-training, 6 , 12 and 18 months post -training
Secondary outcomes (2)
Emotion Scale
The Emotion scale stigma uses10 item Emotion Scale, which assesses perceived emotional responses to interactions with patients with mental illnesses. Participants are instructed to imagine contact with a person with mental illness and to then rate the intensity of 10 emotions participants would experience during this encounter. Nine-point Likert scales (ranging from 1 = weak to 9 = strong) were used to assess the intensity of ten emotions: compassion, interest, sadness, acceptance, anger, dislike, anxiety, aversion, distrust and indifference. The selection of emotions was based on the assumption that these emotions are frequently experienced during the encounter with mentally ill individuals.
Measured: Pre-training, post-training, 6 , 12 and 18 months post -training
PSP resident study_survey v1F Use of and Comfort in Use of Tools and Strategies of the Program
A modified version of of three ad hoc scales developed for a randomized controlled trial in Nova Scotia, the "PSP resident study_survey v1F Use of and Comfort in Use of Tools and Strategies of the Program" measures the use and reported comfort in the use of tools/skills, assessed through a series of simple yes/no responses pertaining to if the physician uses the tool, and measure levels of familiarity, confidence and comfort with program specific tools and skills taught in the program using a 7-point Likert scale (not at all, very low, low, moderate, high, very high).
Measured: Pre-training, post-training, 6 , 12 and 18 months post -training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start5 Oct 2021
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Why it stopped: Substantial efforts to engage participants in the evaluations was unsuccessful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Depression, Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bianca Horner
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor-investigator, Bianca Horner, Nova Scotia Health Authority
- Investigators
- Bianca Lauria-Horner, MD, Principal investigator, Dalhousie University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057026
- Sponsor's protocol ID
- Version1, July 29, 2021
- Status last verified
- Aug 2023
- First submitted
- 10 Sep 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication Conferences
Publications
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.
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.
PubMed 24534819Beaulieu 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.
PubMed 28095259Caldwell 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.
PubMed 11421972Health 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.
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.
PubMed 15491256Emrich 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.
PubMed 12743963Jones 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.
PubMed 18699951Knaak 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.
PubMed 28929889Knaak 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.
PubMed 25565698Knaak 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.
PubMed 27426646Kopera 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.
PubMed 25535045Lauria-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.
PubMed 30486799Lukovic 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.
PubMed 25503967MacCarthy 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.
PubMed 24355885
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mental Health Support Program on Stigmatization and Confidence of Medical Residents Working With People With Mental Health Concerns
- ClinicalTrials.gov ID
- NCT05057026
- Acronym / sponsor ID
- Version1, July 29, 2021
- Conditions
- Depression, Anxiety Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Substantial efforts to engage participants in the evaluations was unsuccessful.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bianca HornerUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult mental health support program | – | Other: Training Program Adult Mental Health Practice Support ProgramThe investigators will evaluate the Impact of an Adult mental health support program on stigmatization and confidence of medical residents working with people with mental health concerns. The intervention will be delivered to approximately 30 residents from the University of Dalhousie family medicine residency program from the 2021-2022 academic year. The training will be delivered by resident groups. The first group will receive the PSP training October - November 2022. The second will receive the training November 2021 to February 2022. The third will take the training March to May 2022. Each group will include approximately 10 residents. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents from the University of Dalhousie family medicine residency program providing care for people with mental health conditions
Key inclusion criteria (2 listed)
- Family Medicine residency program students in the1st year of their program.
- Provision of informed consent In good standing in their program.
Key exclusion criteria (1 listed)
- Medical Students who are not enrolled in Dalhousie University Family Medicine residency program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training Program Adult Mental Health Practice Support ProgramThe Adult Mental Health Practice Support Program (PSP) was designed in 2009 by the General Practice Services Committee (GPSC) 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, * 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 The training will be delivered virtually over a total of 4 sessions two weeks apart, covering an 8-week period. A two hour virtually delivered booster session will be provided to students approximately one year after the delivery of the initial training. | Other | Adult mental health support program |
Primary outcome
Opening Minds Scale for Health Providers (OMS-HC)
Time frame: Pre-training, post-training, 6 , 12 and 18 months post -training
Stigma changes will be measured using the 15 item Opening Minds Scale for Health Providers (OMS-HC), which captures providers' overall mental health related stigma as well as three main dimensions of stigma: negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Total scores can range from 15 to 75, with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. In 2014, a rigorous examination of the psychometric properties and responsiveness of the OMS-HC scale was conducted by Modgill G, et al. Results from this evaluation showed internal consistency as acceptable for all versions of the OMS scale (α = 0.74 to 0.79) and corresponding subscales (α = 0.67 to 0.68), further depicting the OMS-HC as an accurate and reliable instrument
PSP resident study_survey v1F Comfort in Managing Mental Health Conditions
Time frame: Pre-training, post-training, 6 , 12 and 18 months post -training
Confidence in managing depression will be assessed using adaptations of measures used in previous evaluations of this program with practicing primary care physicians. Modified versions of three ad hoc scales developed for a randomized controlled evaluation study in Nova Scotia were used to collect demographic information. The scales were also used to assess levels of confidence on a number of statements pertaining to their ability to diagnose, treat, and otherwise manage patients' mental health concerns using a 7-point Likert scale (not at all, very low, low, moderate, high, very high), with higher scores indicating higher levels of confidence, comfort, and familiarity.
2 secondary outcomes
Emotion Scale
Time frame: Pre-training, post-training, 6 , 12 and 18 months post -training
PSP resident study_survey v1F Use of and Comfort in Use of Tools and Strategies of the Program
Time frame: Pre-training, post-training, 6 , 12 and 18 months post -training
Results and safety
The study was stopped early (reason given: Substantial efforts to engage participants in the evaluations was unsuccessful.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publicationAdshead, 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.
- Results publication: PubMed 24534819Azrin 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.
- Results publication: PubMed 28095259Beaulieu 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.
- Results publication: PubMed 11421972Caldwell 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.
- Results publicationHealth 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.
- Results publication: PubMed 15491256Corrigan P. How stigma interferes with mental health care. Am Psychol. 2004 Oct;59(7):614-625. doi: 10.1037/0003-066X.59.7.614.
- Results publication: PubMed 12743963Emrich 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.
- Results publication: PubMed 18699951Jones 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.
- Results publication: PubMed 28929889Knaak 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.
- Results publication: PubMed 25565698Knaak 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.
- Results publication: PubMed 27426646Knaak 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.
- Results publication: PubMed 25535045Kopera 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.
- Individual participant dataSharing planned: Yes. Publication Conferences
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bianca Lauria-Horner, MD principal investigator
Dalhousie University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety Disorders, run by Bianca Horner at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Substantial efforts to engage participants in the evaluations was unsuccessful.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opening Minds Scale for Health Providers (OMS-HC) (time frame: Pre-training, post-training, 6 , 12 and 18 months post -training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057026, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.