Major Depressive Disorder
Conditions
Keywords
Mental Health, Education and Practice Support Program, Depression, Primary Care, Skill-based training, Patient centered outcomes
Brief 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.
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.
Interventions
OTHERMental Health Practice Support Program
1. 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
OTHERTreatment as Usual
Physicians manage patients with depression as usual
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Physician sample: * A valid license to practice in Nova Scotia. * The provision of informed consent. Patient sample: Inclusion Criteria: * 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.
Exclusion criteria
* Not currently under treatment for depression either with an antidepressant medication or psychotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between Group Changes in Occupational Functioning From Baseline to 6 Months | Baseline, 1, 2, 3, and 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | Baseline, 1, 2,3, and 6 months | The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI 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 CSI 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 Groups Changes in Quality of Life From Baseline to 6 Months. | Baseline, 1, 2, 3 and 6 months | The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 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 SF-36 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 Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness | Baseline and 6 months | A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to: * diagnose depression * screen for addictions * screen for other mental health conditions * treat depression * treat other mental health disorders * prescribe medications for mental health conditions * assess patients' problems and strengths * overall confidence in quality of mental health care provided * knowledge/awareness of non-pharmaceutical interventions * knowledge/awareness of regional mental health resources for patients Cronbach's alpha .84 at pre-test and .87 at post-test |
| Between Group Change in Sheehan Disability Scale (SDS) | Baseline, 1, 2, 3, and 6 months | The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS 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 SDS 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. |
| Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months | 6 months | We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months. |
| Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills | Baseline and 6 months | A modified version of a British Columbia (BC) developed survey Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test, 3 |
| Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills | Baseline and 6 months | A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test |
Countries
Canada
Participant flow
Recruitment details
Seventy seven practices with one hundred and eleven community-based family physicians were recruited between September 2013 and January 2014.
Pre-assignment details
285 participants were enrolled in the study: Physicians (n=111);Patients (n=129); Medical office Staff (MOAs) (n=45) MOA Group: MOAs excluded from outcome analysis due to inconsistent particpation and small sample size
Participants by arm
| Arm | Count |
|---|---|
| Practice Support Program: Physician Sample Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) 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 | 39 |
| Treatment as Usual: Physician Sample Treatment as Usual for Depression
Depression Treatment as Usual: Physicians manage patients with depression as usual | 34 |
| Practice Support Program: Patient Sample Patients of physicians trained in the Adult Mental Health Practice Support Program.
Inclusion criteria included \>18 years of age, with a diagnosis of depression, PHQ-9 score of \> 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician. | 65 |
| Treatment as Usual: Patient Sample Patients of physician who were randomized in the control group (TAU).
Inclusion criteria included \>18 years of age, with a diagnosis of depression, PHQ-9 score of \> 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician. | 51 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 17 | 21 | 7 | 6 |
Baseline characteristics
| Characteristic | Practice Support Program: Physician Sample | Total | Treatment as Usual: Patient Sample | Practice Support Program: Patient Sample | Treatment as Usual: Physician Sample |
|---|---|---|---|---|---|
| Age, Customized Patients 18-29 years | NA Participants | NA Participants | 12 Participants | 11 Participants | NA Participants |
| Age, Customized Patients 30-39 years | NA Participants | NA Participants | 18 Participants | 13 Participants | NA Participants |
| Age, Customized Patients 40-49 years | NA Participants | NA Participants | 8 Participants | 14 Participants | NA Participants |
| Age, Customized Patients 50-59 years | NA Participants | NA Participants | 7 Participants | 9 Participants | NA Participants |
| Age, Customized Patients 60-69 years | NA Participants | NA Participants | 3 Participants | 9 Participants | NA Participants |
| Age, Customized Patients >70 years | NA Participants | NA Participants | 1 Participants | 5 Participants | NA Participants |
| Age, Customized Physician 20-29years | 0 participants | NA participants | NA participants | NA participants | 2 participants |
| Age, Customized Physician 30-39years | 8 participants | NA participants | NA participants | NA participants | 5 participants |
| Age, Customized Physician 40-49years | 10 participants | NA participants | NA participants | NA participants | 14 participants |
| Age, Customized Physician 50-59years | 16 participants | NA participants | NA participants | NA participants | 10 participants |
| Age, Customized Physician 60-69years | 5 participants | NA participants | NA participants | NA participants | 3 participants |
| Education High school diploma | NA Participants | NA Participants | 6 Participants | 14 Participants | NA Participants |
| Education Master's degree or higher | NA Participants | NA Participants | 1 Participants | 5 Participants | NA Participants |
| Education Post-secondary certificate/diploma | NA Participants | NA Participants | 17 Participants | 14 Participants | NA Participants |
| Education Post-secondary degree | NA Participants | NA Participants | 13 Participants | 15 Participants | NA Participants |
| Education Some elementary or high school | NA Participants | NA Participants | 2 Participants | 8 Participants | NA Participants |
| Education Some post-secondary | NA Participants | NA Participants | 10 Participants | 5 Participants | NA Participants |
| Employment status Patients: Employed full time | NA Participants | NA Participants | 26 Participants | 27 Participants | NA Participants |
| Employment status Patients:Employed part time | NA Participants | NA Participants | 13 Participants | 8 Participants | NA Participants |
| Employment status Patients:Retired/student/at-home/other | NA Participants | NA Participants | 15 Participants | 5 Participants | NA Participants |
| Employment status Patients:Unemployed but available to work | NA Participants | NA Participants | 2 Participants | 5 Participants | NA Participants |
| Employment status Patients:Unemployed due to illness | NA Participants | NA Participants | 3 Participants | 6 Participants | NA Participants |
| Marital Status Patients: Married/common-law | NA Participants | NA Participants | 32 Participants | 33 Participants | NA Participants |
| Marital Status Patients: Never married | NA Participants | NA Participants | 10 Participants | 17 Participants | NA Participants |
| Marital Status Patients: Separated/divorced | NA Participants | NA Participants | 5 Participants | 11 Participants | NA Participants |
| Marital Status Patients: Widowed | NA Participants | NA Participants | 2 Participants | 0 Participants | NA Participants |
| Mother tongue Patient: English | NA Participants | NA Participants | 48 Participants | 56 Participants | NA Participants |
| Mother tongue Patient: French | NA Participants | NA Participants | 0 Participants | 3 Participants | NA Participants |
| Mother tongue Patient: Other | NA Participants | NA Participants | 1 Participants | 2 Participants | NA Participants |
| Pattern of work Full time | 34 participants | NA participants | NA participants | NA participants | 29 participants |
| Pattern of work Part time | 5 participants | NA participants | NA participants | NA participants | 5 participants |
| Practice type 2-physician practice | 8 participants | NA participants | NA participants | NA participants | 5 participants |
| Practice type Large gp practice (5+) | 5 participants | NA participants | NA participants | NA participants | 16 participants |
| Practice type Small gp practice (<5) | 16 participants | NA participants | NA participants | NA participants | 8 participants |
| Practice type Solo practice | 9 participants | NA participants | NA participants | NA participants | 5 participants |
| Region of Enrollment Canada | 39 participants | 189 participants | 51 participants | 65 participants | 34 participants |
| Sex: Female, Male Female | 21 Participants | 127 Participants | 40 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Male | 18 Participants | 62 Participants | 11 Participants | 20 Participants | 13 Participants |
| Unique patients/yr 1,000-1,999 | 12 participants | NA participants | NA participants | NA participants | 12 participants |
| Unique patients/yr 2,000-2,999 | 2 participants | NA participants | NA participants | NA participants | 7 participants |
| Unique patients/yr 3,000 or more | 11 participants | NA participants | NA participants | NA participants | 6 participants |
| Unique patients/yr Fewer than 1,000 | 6 participants | NA participants | NA participants | NA participants | 7 participants |
| Unique patients/yr Other (hospitalist, locum, etc) | 2 participants | NA participants | NA participants | NA participants | 0 participants |
| Who do you usually live with? Patient:Alone | NA Participants | NA Participants | 6 Participants | 13 Participants | NA Participants |
| Who do you usually live with? Patient:Children (but no spouse/partner) | NA Participants | NA Participants | 2 Participants | 4 Participants | NA Participants |
| Who do you usually live with? Patient: Husband/wife/steady partner | NA Participants | NA Participants | 17 Participants | 18 Participants | NA Participants |
| Who do you usually live with? Patient:Other | NA Participants | NA Participants | 1 Participants | 6 Participants | NA Participants |
| Who do you usually live with? Patient:Parents | NA Participants | NA Participants | 4 Participants | 4 Participants | NA Participants |
| Who do you usually live with? Patient:Spouse partner and children | NA Participants | NA Participants | 19 Participants | 15 Participants | NA Participants |
| Years in practice 10-14years | 3 participants | NA participants | NA participants | NA participants | 5 participants |
| Years in practice 1-4years | 7 participants | NA participants | NA participants | NA participants | 2 participants |
| Years in practice 15-19years | 1 participants | NA participants | NA participants | NA participants | 6 participants |
| Years in practice 20-24years | 9 participants | NA participants | NA participants | NA participants | 3 participants |
| Years in practice 25-29years | 9 participants | NA participants | NA participants | NA participants | 7 participants |
| Years in practice 30 years or more | 5 participants | NA participants | NA participants | NA participants | 6 participants |
| Years in practice 5-9years | 3 participants | NA participants | NA participants | NA participants | 3 participants |
| Years in practice Less than 1 year | 0 participants | NA participants | NA participants | NA participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline and at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Attitudes subscale: 6 months | 1.97 units on a scale | Standard Deviation 0.49 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | OMS-HC Total Score 6 months | 2.07 units on a scale | Standard Deviation 0.46 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Disclosure/help-seeking: Baselinr | 2.65 units on a scale | Standard Deviation 0.66 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | OMS-HC Total Score Baseline | 2.21 units on a scale | Standard Deviation 0.4 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Disclosure/help-seeking: 6 months | 2.57 units on a scale | Standard Deviation 0.75 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Attitudes subscale:Baseline | 2.13 units on a scale | Standard Deviation 0.48 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Social distance: Baseline | 1.95 units on a scale | Standard Deviation 0.46 |
| Mental Health PSP: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Social distance : 6 months | 1.79 units on a scale | Standard Deviation 0.55 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Social distance : 6 months | 1.82 units on a scale | Standard Deviation 0.48 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | OMS-HC Total Score Baseline | 2.11 units on a scale | Standard Deviation 0.35 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | OMS-HC Total Score 6 months | 2.07 units on a scale | Standard Deviation 0.38 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Attitudes subscale:Baseline | 2.02 units on a scale | Standard Deviation 0.48 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Attitudes subscale: 6 months | 1.9 units on a scale | Standard Deviation 0.51 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Disclosure/help-seeking: Baselinr | 2.65 units on a scale | Standard Deviation 0.61 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Disclosure/help-seeking: 6 months | 2.63 units on a scale | Standard Deviation 0.52 |
| Treatment as Usual: Patients | Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | Social distance: Baseline | 1.77 units on a scale | Standard Deviation 0.39 |
Comparison: Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.p-value: 0.15Mixed Models Analysis
Comparison: Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.p-value: 0.03Mixed Models Analysis
Primary
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.
Time frame: Baseline, 1, 2, 3, and 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 1 month | 11.25 units on a scale | Standard Deviation 5.82 |
| Mental Health PSP: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 3 months | 8.44 units on a scale | Standard Deviation 6.15 |
| Mental Health PSP: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 2 months | 9.72 units on a scale | Standard Deviation 6.28 |
| Mental Health PSP: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 6 month | 6.78 units on a scale | Standard Deviation 5.41 |
| Mental Health PSP: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | baseline | 16.43 units on a scale | Standard Deviation 4.77 |
| Treatment as Usual: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 6 month | 8.42 units on a scale | Standard Deviation 6.57 |
| Treatment as Usual: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | baseline | 17.28 units on a scale | Standard Deviation 4.12 |
| Treatment as Usual: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 1 month | 10.39 units on a scale | Standard Deviation 6.49 |
| Treatment as Usual: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 2 months | 8.46 units on a scale | Standard Deviation 6.47 |
| Treatment as Usual: Patients | Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | 3 months | 7.55 units on a scale | Standard Deviation 6.13 |
Comparison: One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.p-value: 0.047Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 1, 2, 3, and 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 1 month | 7.67 units on a scale | Standard Deviation 5.36 |
| Mental Health PSP: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 3 months | 5.54 units on a scale | Standard Deviation 4.37 |
| Mental Health PSP: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | Baseline | 11.26 units on a scale | Standard Deviation 5.8 |
| Mental Health PSP: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 6 months | 6.04 units on a scale | Standard Deviation 5.79 |
| Mental Health PSP: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 2 months | 7.45 units on a scale | Standard Deviation 6.21 |
| Treatment as Usual: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 6 months | 6.03 units on a scale | Standard Deviation 6.12 |
| Treatment as Usual: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 1 month | 7.13 units on a scale | Standard Deviation 5.96 |
| Treatment as Usual: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 2 months | 7.16 units on a scale | Standard Deviation 6.88 |
| Treatment as Usual: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | 3 months | 5.96 units on a scale | Standard Deviation 5.06 |
| Treatment as Usual: Patients | Between Group Changes in Occupational Functioning From Baseline to 6 Months | Baseline | 12.76 units on a scale | Standard Deviation 6.52 |
p-value: 0.993Mixed Models Analysis
Other Pre-specified
Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months
The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI 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 CSI 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.
Time frame: Baseline, 1, 2,3, and 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | I month | 6.1 units on a scale | Standard Deviation 0.79 |
| Mental Health PSP: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 3 months | 6.1 units on a scale | Standard Deviation 0.93 |
| Mental Health PSP: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 2 months | 6.2 units on a scale | Standard Deviation 0.76 |
| Mental Health PSP: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 6 months | 6.1 units on a scale | Standard Deviation 0.79 |
| Mental Health PSP: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | Baseline | 6.3 units on a scale | Standard Deviation 0.51 |
| Treatment as Usual: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 6 months | 6.0 units on a scale | Standard Deviation 1 |
| Treatment as Usual: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | Baseline | 6.1 units on a scale | Standard Deviation 0.87 |
| Treatment as Usual: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | I month | 6.1 units on a scale | Standard Deviation 0.95 |
| Treatment as Usual: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 2 months | 6.2 units on a scale | Standard Deviation 0.95 |
| Treatment as Usual: Patients | Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months | 3 months | 6.1 units on a scale | Standard Deviation 0.91 |
p-value: 0.742Mixed Models Analysis
Other Pre-specified
Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness
A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to: * diagnose depression * screen for addictions * screen for other mental health conditions * treat depression * treat other mental health disorders * prescribe medications for mental health conditions * assess patients' problems and strengths * overall confidence in quality of mental health care provided * knowledge/awareness of non-pharmaceutical interventions * knowledge/awareness of regional mental health resources for patients Cronbach's alpha .84 at pre-test and .87 at post-test
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness | Baseline Management of mental illness | 2.18 units on a scale | Standard Deviation 0.39 |
| Mental Health PSP: Patients | Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness | 6 monthsManagement of mental illness | 1.80 units on a scale | Standard Deviation 0.36 |
| Treatment as Usual: Patients | Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness | Baseline Management of mental illness | 2.03 units on a scale | Standard Deviation 0.37 |
| Treatment as Usual: Patients | Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness | 6 monthsManagement of mental illness | 2.12 units on a scale | Standard Deviation 0.4 |
p-value: <0.001Mixed Models Analysis
Comparison: Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.p-value: 0.03Generalized estimating equations (GEE)
Other Pre-specified
Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills
A modified version of a British Columbia (BC) developed survey Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test, 3
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills | Baseline non-program specific mental health tools | 2.34 units on a scale | Standard Deviation 0.4 |
| Mental Health PSP: Patients | Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills | 6 months non-program specific mental health tools | 1.81 units on a scale | Standard Deviation 0.4 |
| Treatment as Usual: Patients | Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills | Baseline non-program specific mental health tools | 2.27 units on a scale | Standard Deviation 0.5 |
| Treatment as Usual: Patients | Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills | 6 months non-program specific mental health tools | 2.32 units on a scale | Standard Deviation 0.48 |
p-value: <0.001Mixed Models Analysis
Comparison: Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.p-value: 0.476Generalized estimating equations (GEE)
Other Pre-specified
Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills
A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills | Baseline program specific mental health tools | 2.82 units on a scale | Standard Deviation 0.31 |
| Mental Health PSP: Patients | Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills | 6 months program specific mental health tools | 1.79 units on a scale | Standard Deviation 0.44 |
| Treatment as Usual: Patients | Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills | Baseline program specific mental health tools | 2.80 units on a scale | Standard Deviation 0.2 |
| Treatment as Usual: Patients | Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills | 6 months program specific mental health tools | 2.64 units on a scale | Standard Deviation 0.21 |
p-value: <0.001Mixed Models Analysis
Comparison: Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.p-value: 0.945Generalized estimating equations (GEE)
Other Pre-specified
Between Group Change in Sheehan Disability Scale (SDS)
The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS 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 SDS 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.
Time frame: Baseline, 1, 2, 3, and 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 1 month | 13.87 units on a scale | Standard Deviation 8.19 |
| Mental Health PSP: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 3 months | 10.42 units on a scale | Standard Deviation 9.34 |
| Mental Health PSP: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 2 months | 13.74 units on a scale | Standard Deviation 9.12 |
| Mental Health PSP: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 6 months | 7.64 units on a scale | Standard Deviation 7.27 |
| Mental Health PSP: Patients | Between Group Change in Sheehan Disability Scale (SDS) | Baseline | 18.87 units on a scale | Standard Deviation 7.06 |
| Treatment as Usual: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 6 months | 7.86 units on a scale | Standard Deviation 8.46 |
| Treatment as Usual: Patients | Between Group Change in Sheehan Disability Scale (SDS) | Baseline | 19.83 units on a scale | Standard Deviation 6.2 |
| Treatment as Usual: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 1 month | 13.03 units on a scale | Standard Deviation 8.99 |
| Treatment as Usual: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 2 months | 9.43 units on a scale | Standard Deviation 8.95 |
| Treatment as Usual: Patients | Between Group Change in Sheehan Disability Scale (SDS) | 3 months | 8.28 units on a scale | Standard Deviation 7.29 |
p-value: 0.213Mixed Models Analysis
Other Pre-specified
Between Groups Changes in Quality of Life From Baseline to 6 Months.
The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 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 SF-36 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.
Time frame: Baseline, 1, 2, 3 and 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Health PSP: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 1 month | 57.73 units on a scale | Standard Deviation 17.09 |
| Mental Health PSP: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 3 months | 62.45 units on a scale | Standard Deviation 21.76 |
| Mental Health PSP: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 2 months | 61.77 units on a scale | Standard Deviation 18.38 |
| Mental Health PSP: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 6 months | 67.09 units on a scale | Standard Deviation 20.88 |
| Mental Health PSP: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | Baseline | 54.03 units on a scale | Standard Deviation 14.07 |
| Treatment as Usual: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 6 months | 69.03 units on a scale | Standard Deviation 21.26 |
| Treatment as Usual: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | Baseline | 54.10 units on a scale | Standard Deviation 12.92 |
| Treatment as Usual: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 1 month | 62.33 units on a scale | Standard Deviation 15.3 |
| Treatment as Usual: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 2 months | 67.62 units on a scale | Standard Deviation 15.59 |
| Treatment as Usual: Patients | Between Groups Changes in Quality of Life From Baseline to 6 Months. | 3 months | 66.99 units on a scale | Standard Deviation 18.83 |
p-value: 0.543Mixed Models Analysis
Other Pre-specified
Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months
We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.
Time frame: 6 months
Population: All participants with at least one follow-up data (n=116) were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mental Health PSP: Patients | Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months | 31 Participants |
| Treatment as Usual: Patients | Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months | 35 Participants |
p-value: 0.009Mixed Models Analysis