Major Depressive DisorderNCT01975948
Evaluation of a Mental Health Physician Support Program in Nova Scotia
A study testing Mental Health Practice Support Program and Treatment as Usual in people with Major Depressive Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The aim of this study is to test the program's effectiveness in a primary care setting in reducing stigma among medical personnel, increasing the comfort level of physicians and staff in providing care to those living with mental illness, and in improving client well-being and mental health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mental Health Practice Support Program and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depression defined by PHQ-9 score of > 10.
- > 18 years old.
- Able to read and speak English.
- Sufficiently intact cognitive functioning (physician judgement).
- Free of urgent or emergent medical or psychiatric issues e.g. unstable cardiovascular disease, suicidal ideation.
Who cannot join
- Not currently under treatment for depression either with an antidepressant medication or psychotherapy.
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: Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization
The aim of this study is to test the program's effectiveness in a primary care setting in reducing stigma among medical personnel, increasing the comfort level of physicians and staff in providing care to those living with mental illness, and in improving client well-being and mental health.
Read the detailed description
Skill-based approaches are effective in reducing stigma in health professionals.
Overview: The Nova Scotia (NS) Department of Health and Wellness and the Mental Health Commission of Canada launched a demonstration project in NS-Adult Mental Health Practice Support Program. Originating in British Columbia (BC), it uses a novel learning platform which supports primary healthcare providers with treatment and management of mental illness. We hypothesized that enhanced skills in program participants would lead to increased comfort on the part of practitioners, diminished social distance and stigmatization; improved clinical outcomes and a reduction in healthcare costs.
This evaluation has three co-primary objectives:
- To determine whether the Mental Health Practice Support Program (PSP) leads to lower levels of stigma among physicians participating in the program.
- To determine whether participation in the Mental Health PSP leads to lower levels of stigma among medical office assistants (MOAs)
- To determine whether participation of physicians in the Mental Health PSP leads to greater improvement in depressive symptom ratings among patients they are treating for depression, compared to treatment as usual.
Two secondary objectives:
- To determine whether participation in the PSP leads to improved occupational functioning compared to treatment as usual.
- To assess the impact of participation in the Mental Health PSP on healthcare costs.
Four exploratory objectives:
- To assess physicians' confidence and comfort in the management of depression treatment
- To determine whether physician participation int he Mental Health PSP is associated with a reduced frequency of antidepressant prescribing.
- To determine whether the patients of physicians participating in the Mental Health PSP report higher levels of satisfaction with the treatment that they receive.
- To determine whether patients participation in the Mental Health PSP is associated with improved quality of life.
Methods: Seventy seven practices with one hundred and eleven community-based family physicians were recruited. Each practice was assigned a practice number. Each physician within the practice was assigned a unique identifier number. Individual practitioner or practice teams were randomly assigned to intervention or control groups. Randomization was stratified on the total number of physicians per practice, as well as urban or rural setting to ensure equal distribution of practice clusters and urban and rural groups. STATA, version 12 [College Station, TX, 2012] to generate the sequence for practice [cluster] randomization. Random numbers were generated from a binomial distribution with a probability of success of 0.5. Intervention group participants attended 3 half-day workshops with a "6- week action period" between workshops to practice learnings. Practice support was provided through diagnostic assessment tools, evidence based self-management tools, and on-site practice support coordinator support. A stigma-assessment tool, the Opening Minds Scale for Healthcare Providers (OMS-HC), was administered to both groups at intervention group pre-training, and post-training. Providers comfort and confidence in diagnosing and managing mental illness was also assessed, at comparable times.
Upon completion of the intervention group training, physicians from both groups were asked to identify 3 consecutive evaluable patients. Patients were enrolled and allocated to intervention or control groups as per their associated physician.
- Conditions
- Major Depressive Disorder
- Being tested
- Mental Health Practice Support Program, Treatment as Usual
- Keywords
- Mental Health, Education and Practice Support Program, Depression, Primary Care, Skill-based training, Patient centered outcomes
- Medical subject headings
- Depressive Disorder, Major, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Practice Support ProgramOther
- training and (2) practice support.
- Three half day workshop sessions over a 24 week period.
- Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes
Treatment as UsualOther
Physicians manage patients with depression as usual
| Study group | Role | What they receive |
|---|---|---|
| Mental Health PSP: Physicians | Experimental | Physicians training in Adult Mental Health Practice Support Program Receives: Other: Mental Health Practice Support Program |
| Treatment as Usual: Physicians | Active comparator | Those administering treatment as usual for depression Receives: Other: Treatment as Usual |
| Mental Health PSP: Patients | Experimental | Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training. Receives: Other: Mental Health Practice Support Program |
| Treatment as Usual: Patients | Active comparator | Those receiving treatment as usual for depression Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Measured: Baseline, 1, 2, 3, and 6 months
Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)
The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures 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. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.
Measured: Baseline and at 6 months
Secondary outcomes (1)
Between Group Changes in Occupational Functioning From Baseline to 6 Months
Lam's Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Measured: Baseline, 1, 2, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Horner, Nova Scotia Health Authority
- Investigators
- Bianca A Lauria-Horner, MD, Principal investigator, Associate Professor Dalhousie University Department of PsychiatryScott Patten, FRCP(C), PhD, Principal investigator, Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975948
- Sponsor's protocol ID
- CDHA-RS/2014-150
- Status last verified
- Sep 2021
- First submitted
- 21 Oct 2013
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results will be distributed through publications in academic journals and presented at upcoming conferences, study sponsors and contributors: i.e. the Mental Health Commission of Canada, the Nova Scotia Department of Health and Wellness, Dalhousie University, the University of Calgary, Doctors of Nova Scotia, study participants, etc. Study Protocol, SAP, and Informed Consent will be shared. However when SAP is checked below in IPD sharing field, it will not allow to be saved (check-mark in SAP does not remain when save button is clicked). De-identified patient data will not be shared as we made a commitment to physicians that only the PI would have access to this information, even though de-identified, some were concerned that patients could still be identified.
Publications
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.
PubMed 30486799
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization
- ClinicalTrials.gov ID
- NCT01975948
- Acronym / sponsor ID
- CDHA-RS/2014-150
- Conditions
- Major Depressive Disorder
- Keywords
- Mental Health, Education and Practice Support Program, Depression, Primary Care, Skill-based training, Patient centered outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the program's effectiveness in a primary care setting in reducing stigma among medical personnel, increasing the comfort level of physicians and staff in providing care to those living with mental illness, and in improving client well-being and mental health.
Detailed description
Skill-based approaches are effective in reducing stigma in health professionals.
Overview: The Nova Scotia (NS) Department of Health and Wellness and the Mental Health Commission of Canada launched a demonstration project in NS-Adult Mental Health Practice Support Program. Originating in British Columbia (BC), it uses a novel learning platform which supports primary healthcare providers with treatment and management of mental illness. We hypothesized that enhanced skills in program participants would lead to increased comfort on the part of practitioners, diminished social distance and stigmatization; improved clinical outcomes and a reduction in healthcare costs.
This evaluation has three co-primary objectives:
- To determine whether the Mental Health Practice Support Program (PSP) leads to lower levels of stigma among physicians participating in the program.
- To determine whether participation in the Mental Health PSP leads to lower levels of stigma among medical office assistants (MOAs)
- To determine whether participation of physicians in the Mental Health PSP leads to greater improvement in depressive symptom ratings among patients they are treating for depression, compared to treatment as usual.
Two secondary objectives:
- To determine whether participation in the PSP leads to improved occupational functioning compared to treatment as usual.
- To assess the impact of participation in the Mental Health PSP on healthcare costs.
Four exploratory objectives:
- To assess physicians' confidence and comfort in the management of depression treatment
- To determine whether physician participation int he Mental Health PSP is associated with a reduced frequency of antidepressant prescribing.
- To determine whether the patients of physicians participating in the Mental Health PSP report higher levels of satisfaction with the treatment that they receive.
- To determine whether patients participation in the Mental Health PSP is associated with improved quality of life.
Methods: Seventy seven practices with one hundred and eleven community-based family physicians were recruited. Each practice was assigned a practice number. Each physician within the practice was assigned a unique identifier number. Individual practitioner or practice teams were randomly assigned to intervention or control groups. Randomization was stratified on the total number of physicians per practice, as well as urban or rural setting to ensure equal distribution of practice clusters and urban and rural groups. STATA, version 12 [College Station, TX, 2012] to generate the sequence for practice [cluster] randomization. Random numbers were generated from a binomial distribution with a probability of success of 0.5. Intervention group participants attended 3 half-day workshops with a "6- week action period" between workshops to practice learnings. Practice support was provided through diagnostic assessment tools, evidence based self-management tools, and on-site practice support coordinator support. A stigma-assessment tool, the Opening Minds Scale for Healthcare Providers (OMS-HC), was administered to both groups at intervention group pre-training, and post-training. Providers comfort and confidence in diagnosing and managing mental illness was also assessed, at comparable times.
Upon completion of the intervention group training, physicians from both groups were asked to identify 3 consecutive evaluable patients. Patients were enrolled and allocated to intervention or control groups as per their associated physician.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mental Health PSP: Physicians | Experimental | Other: Mental Health Practice Support ProgramPhysicians training in Adult Mental Health Practice Support Program |
| Treatment as Usual: Physicians | Active comparator | Other: Treatment as UsualThose administering treatment as usual for depression |
| Mental Health PSP: Patients | Experimental | Other: Mental Health Practice Support ProgramThose belonging to a physician who has completed the Adult Mental Health Practice Support Program training. |
| Treatment as Usual: Patients | Active comparator | Other: Treatment as UsualThose receiving treatment as usual for depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Depression defined by PHQ-9 score of > 10.
- > 18 years old.
- Able to read and speak English.
- Sufficiently intact cognitive functioning (physician judgement).
- Free of urgent or emergent medical or psychiatric issues e.g. unstable cardiovascular disease, suicidal ideation.
Key exclusion criteria (1 listed)
- Not currently under treatment for depression either with an antidepressant medication or psychotherapy.
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 |
|---|---|---|
| Mental Health Practice Support Program1. training and (2) practice support. * Three half day workshop sessions over a 24 week period. * Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes | Other | Mental Health PSP: Patients, Mental Health PSP: Physicians |
| Treatment as UsualPhysicians manage patients with depression as usual | Other | Treatment as Usual: Patients, Treatment as Usual: Physicians |
Primary outcome
Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
Time frame: Baseline, 1, 2, 3, and 6 months
The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)
Time frame: Baseline and at 6 months
The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures 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. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.
1 secondary outcome
Between Group Changes in Occupational Functioning From Baseline to 6 Months
Time frame: Baseline, 1, 2, 3, and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30486799Lauria-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.
- Individual participant dataSharing planned: Yes. Results will be distributed through publications in academic journals and presented at upcoming conferences, study sponsors and contributors: i.e. the Mental Health Commission of Canada, the Nova Scotia Department of Health and Wellness, Dalhousie University, the University of Calgary, Doctors of Nova Scotia, study participants, etc. Study Protocol, SAP, and Informed Consent will be shared. However when SAP is checked below in IPD sharing field, it will not allow to be saved (check-mark in SAP does not remain when save button is clicked). De-identified patient data will not be shared as we made a commitment to physicians that only the PI would have access to this information, even though de-identified, some were concerned that patients could still be identified.
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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 A Lauria-Horner, MD principal investigator
Associate Professor Dalhousie University Department of Psychiatry
Scott Patten, FRCP(C), PhD principal investigator
Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Practice Support Program and Treatment as Usual in people with Major Depressive Disorder, run by Nova Scotia Health Authority 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 5 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: finished, as of the sponsor's last update on 14 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline (time frame: Baseline, 1, 2, 3, and 6 months). 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 NCT01975948, which also lists 1 linked publication.
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 14 Oct 2021.