Evaluation of a Mental Health Physician Support Program in Nova Scotia

• ClinicalTrials.gov Identifier: NCT01975948
• Recruitment Status: Completed
• First Posted: November 5, 2013
• Results First Posted: June 26, 2017
• Last Update Posted: October 14, 2021
• Sponsor: Nova Scotia Health Authority
• Information provided by (Responsible Party): Bianca Horner, Nova Scotia Health Authority

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Major Depressive Disorder
• Interventions: Other: Mental Health Practice Support Program; Other: Treatment as Usual
• Enrollment: 285

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

Arm/Group Title	Mental Health Practice Support Program;Physician Sample	Depression Treatment as Usual;Physician Sample	Mental Health Practice Support Program;Patient Sample	Treatment as Usual: Patient Sample
Arm/Group Description	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	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual	Patients were assigned to the same arm as their physician who were randomized to the Practice Support Program training. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015	Patients were assigned to the same arm as their physician, who were randomized to treating their patients as usual. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
Period Title: Overall Study
Started	56	55	72	57
Completed	39	34	65	51
Not Completed	17	21	7	6
Reason Not Completed
Withdrawal by Subject	17	21	7	6

Baseline Characteristics

Arm/Group Title		Practice Support Program: Physician Sample	Treatment as Usual: Physician Sample	Practice Support Program: Patient Sample	Treatment as Usual: Patient Sample	Total
Arm/Group Description		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	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual	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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		39	34	65	51	189
Baseline Analysis Population Description		It should be noted that baseline measures for the physician group are based on pre and post training completers (n=73). Patient data is based on those who completed at least one data time point (n=116).
Age, Customized [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Physician 20-29years		0	2	NA [2]	NA [2]	NA [3]
Physician 30-39years		8	5	NA [2]	NA [2]	NA [3]
Physician 40-49years		10	14	NA [2]	NA [2]	NA [3]
Physician 50-59years		16	10	NA [2]	NA [2]	NA [3]
Physician 60-69years		5	3	NA [2]	NA [2]	NA [3]
		[1] Measure Description: Measures for the physician group are based on pre and post training completers (n=73).; [2] This section applies only to physician population; [3] Total not calculated because data are not available (NA) in one or more arms.
Age, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Patients 18-29 years		NA [2]	NA [2]	11 16.9%	12 23.5%	NA [3]
Patients 30-39 years		NA [2]	NA [2]	13 20.0%	18 35.3%	NA [3]
Patients 40-49 years		NA [2]	NA [2]	14 21.5%	8 15.7%	NA [3]
Patients 50-59 years		NA [2]	NA [2]	9 13.8%	7 13.7%	NA [3]
Patients 60-69 years		NA [2]	NA [2]	9 13.8%	3 5.9%	NA [3]
Patients >70 years		NA [2]	NA [2]	5 7.7%	1 2.0%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
	Female	21 53.8%	21 61.8%	45 69.2%	40 78.4%	127 67.2%
	Male	18 46.2%	13 38.2%	20 30.8%	11 21.6%	62 32.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Canada	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
		39	34	65	51	189
Years in practice [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Less than 1 year		0	2	NA [2]	NA [2]	NA [3]
1-4years		7	2	NA [2]	NA [2]	NA [3]
5-9years		3	3	NA [2]	NA [2]	NA [3]
10-14years		3	5	NA [2]	NA [2]	NA [3]
15-19years		1	6	NA [2]	NA [2]	NA [3]
20-24years		9	3	NA [2]	NA [2]	NA [3]
25-29years		9	7	NA [2]	NA [2]	NA [3]
30 years or more		5	6	NA [2]	NA [2]	NA [3]
		[1] Measure Description: Measures for the physician group are based on pre and post training completers (n=73).; [2] This section applies only to physician group; [3] Total not calculated because data are not available (NA) in one or more arms.
Pattern of work [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Full time		34	29	NA [2]	NA [2]	NA [3]
Part time		5	5	NA [2]	NA [2]	NA [3]
		[1] Measure Description: Measures for the physician group are based on pre and post training completers (n=73).; [2] This section applies only to physician group; [3] Total not calculated because data are not available (NA) in one or more arms.
Practice type [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Solo practice		9	5	NA [2]	NA [2]	NA [3]
2-physician practice		8	5	NA [2]	NA [2]	NA [3]
Small gp practice (<5)		16	8	NA [2]	NA [2]	NA [3]
Large gp practice (5+)		5	16	NA [2]	NA [2]	NA [3]
		[1] Measure Description: Measures for the physician group are based on pre and post training completers (n=73); [2] This section applies only to physician group; [3] Total not calculated because data are not available (NA) in one or more arms
Unique patients/yr [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Fewer than 1,000		6	7	NA [2]	NA [2]	NA [3]
1,000-1,999		12	12	NA [2]	NA [2]	NA [3]
2,000-2,999		2	7	NA [2]	NA [2]	NA [3]
3,000 or more		11	6	NA [2]	NA [2]	NA [3]
Other (hospitalist, locum, etc)		2	0	NA [2]	NA [2]	NA [3]
		[1] Measure Description: Measures for the physician group are based on pre and post training completers (n=73); [2] This section applies only to physician group; [3] Total not calculated because data are not available (NA) in one or more arms
Marital Status [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Patients: Married/common-law		NA [2]	NA [2]	33 50.8%	32 62.7%	NA [3]
Patients: Separated/divorced		NA [2]	NA [2]	11 16.9%	5 9.8%	NA [3]
Patients: Never married		NA [2]	NA [2]	17 26.2%	10 19.6%	NA [3]
Patients: Widowed		NA [2]	NA [2]	0 0.0%	2 3.9%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.
Employment status [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Patients: Employed full time		NA [2]	NA [2]	27 41.5%	26 51.0%	NA [3]
Patients:Employed part time		NA [2]	NA [2]	8 12.3%	13 25.5%	NA [3]
Patients:Unemployed but available to work		NA [2]	NA [2]	5 7.7%	2 3.9%	NA [3]
Patients:Unemployed due to illness		NA [2]	NA [2]	6 9.2%	3 5.9%	NA [3]
Patients:Retired/student/at-home/other		NA [2]	NA [2]	5 7.7%	15 29.4%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.
Education [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Some elementary or high school		NA [2]	NA [2]	8 12.3%	2 3.9%	NA [3]
High school diploma		NA [2]	NA [2]	14 21.5%	6 11.8%	NA [3]
Some post-secondary		NA [2]	NA [2]	5 7.7%	10 19.6%	NA [3]
Post-secondary certificate/diploma		NA [2]	NA [2]	14 21.5%	17 33.3%	NA [3]
Post-secondary degree		NA [2]	NA [2]	15 23.1%	13 25.5%	NA [3]
Master's degree or higher		NA [2]	NA [2]	5 7.7%	1 2.0%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.
Mother tongue [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Patient: English		NA [2]	NA [2]	56 86.2%	48 94.1%	NA [3]
Patient: French		NA [2]	NA [2]	3 4.6%	0 0.0%	NA [3]
Patient: Other		NA [2]	NA [2]	2 3.1%	1 2.0%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.
Who do you usually live with? [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	39 participants	34 participants	65 participants	51 participants	189 participants
Patient: Husband/wife/steady partner		NA [2]	NA [2]	18 27.7%	17 33.3%	NA [3]
Patient:Spouse partner and children		NA [2]	NA [2]	15 23.1%	19 37.3%	NA [3]
Patient:Children (but no spouse/partner)		NA [2]	NA [2]	4 6.2%	2 3.9%	NA [3]
Patient:Parents		NA [2]	NA [2]	4 6.2%	4 7.8%	NA [3]
Patient:Alone		NA [2]	NA [2]	13 20.0%	6 11.8%	NA [3]
Patient:Other		NA [2]	NA [2]	6 9.2%	1 2.0%	NA [3]
		[1] Measure Description: Patient data is based on those who completed at least one data time point (n=116).; [2] This section applies only to patient population; [3] Total not calculated because data are not available (NA) in one or more arms.

Outcome Measures

1. Primary Outcome

Title	Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
Description	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

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Mean (Standard Deviation); Unit of Measure: units on a scale
baseline	16.43 (4.77)	17.28 (4.12)
1 month	11.25 (5.82)	10.39 (6.49)
2 months	9.72 (6.28)	8.46 (6.47)
3 months	8.44 (6.15)	7.55 (6.13)
6 month	6.78 (5.41)	8.42 (6.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	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.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.047
	Comments	Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).
	Method	Mixed Models Analysis
	Comments	[Not Specified]

2. Primary Outcome

Title	Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description:	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	Depression Treatment as Usual: Physicians manage patients with depression as usual
Overall Number of Participants Analyzed	39	34
Mean (Standard Deviation); Unit of Measure: units on a scale
OMS-HC Total Score Baseline	2.21 (.40)	2.11 (.35)
OMS-HC Total Score 6 months	2.07 (.46)	2.07 (.38)
Attitudes subscale:Baseline	2.13 (.48)	2.02 (.48)
Attitudes subscale: 6 months	1.97 (.49)	1.9 (.51)
Disclosure/help-seeking: Baselinr	2.65 (.66)	2.65 (.61)
Disclosure/help-seeking: 6 months	2.57 (.75)	2.63 (.52)
Social distance: Baseline	1.95 (.46)	1.77 (.39)
Social distance : 6 months	1.79 (.55)	1.82 (.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	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.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.15
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	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.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.03
	Comments	OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	.45
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Between Group Changes in Occupational Functioning From Baseline to 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	11.26 (5.80)	12.76 (6.52)
1 month	7.67 (5.36)	7.13 (5.96)
2 months	7.45 (6.21)	7.16 (6.88)
3 months	5.54 (4.37)	5.96 (5.06)
6 months	6.04 (5.79)	6.03 (6.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.993
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

4. Other Pre-specified Outcome

Title	Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Practice Support Program: Physician Sample	Treatment as Usual: Physician Sample
Arm/Group Description:	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	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual
Overall Number of Participants Analyzed	39	34
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline Management of mental illness	2.18 (.39)	2.03 (.37)
6 monthsManagement of mental illness	1.80 (.36)	2.12 (.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Practice Support Program: Physician Sample, Treatment as Usual: Physician Sample
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	1.48
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Practice Support Program: Physician Sample, Treatment as Usual: Physician Sample
	Comments	Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.03
	Comments	[Not Specified]
	Method	Generalized estimating equations (GEE)
	Comments	We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.

5. Other Pre-specified Outcome

Title	Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description:	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	Depression Treatment as Usual: Physicians manage patients with depression as usual
Overall Number of Participants Analyzed	39	34
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline non-program specific mental health tools	2.34 (.4)	2.27 (.5)
6 months non-program specific mental health tools	1.81 (.4)	2.32 (.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	1.44
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.476
	Comments	We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.
	Method	Generalized estimating equations (GEE)
	Comments	[Not Specified]

6. Other Pre-specified Outcome

Title	Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description:	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	Depression Treatment as Usual: Physicians manage patients with depression as usual
Overall Number of Participants Analyzed	39	34
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline program specific mental health tools	2.82 (.31)	2.80 (.20)
6 months program specific mental health tools	1.79 (.44)	2.64 (.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	3.25
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Physicians, Treatment as Usual: Physicians
	Comments	Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.945
	Comments	We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.
	Method	Generalized estimating equations (GEE)
	Comments	[Not Specified]

7. Other Pre-specified Outcome

Title	Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	6.3 (.51)	6.1 (.87)
I month	6.1 (.79)	6.1 (.95)
2 months	6.2 (.76)	6.2 (.95)
3 months	6.1 (.93)	6.1 (.91)
6 months	6.1 (.79)	6.0 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.742
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

8. Other Pre-specified Outcome

Title	Between Groups Changes in Quality of Life From Baseline to 6 Months.
Description	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

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	54.03 (14.07)	54.10 (12.92)
1 month	57.73 (17.09)	62.33 (15.30)
2 months	61.77 (18.38)	67.62 (15.59)
3 months	62.45 (21.76)	66.99 (18.83)
6 months	67.09 (20.88)	69.03 (21.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.543
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

9. Other Pre-specified Outcome

Title	Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months
Description	We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Measure Type: Count of Participants; Unit of Measure: Participants
	31 47.7%	35 68.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

10. Other Pre-specified Outcome

Title	Between Group Change in Sheehan Disability Scale (SDS)
Description	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

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description:	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Overall Number of Participants Analyzed	65	51
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	18.87 (7.06)	19.83 (6.20)
1 month	13.87 (8.19)	13.03 (8.99)
2 months	13.74 (9.12)	9.43 (8.95)
3 months	10.42 (9.34)	8.28 (7.29)
6 months	7.64 (7.27)	7.86 (8.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.213
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Serious and other adverse events were not monitored/assessed. The clinical skills and knowledge addressed in the training are standard approaches, involving cognitive and behavioral strategies. There are no risks associated with the implementation of these strategies.
Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
All-Cause Mortality
	Mental Health PSP: Patients	Treatment as Usual: Patients
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Mental Health PSP: Patients	Treatment as Usual: Patients
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Mental Health PSP: Patients	Treatment as Usual: Patients
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0

Limitations and Caveats

Challenges in physician sample: 75% completed pre-post OMS-HC scale Physicians experienced challenges identifying study patients leading to small number of patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Bianca Lauria-Horner
• Organization: Dalhousie University, Department of Psychiatry
• Phone: 902-473-5633
• EMail: bianca.horner@dal.ca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bianca Horner, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT01975948
• Other Study ID Numbers: CDHA-RS/2014-150
• First Submitted: October 21, 2013
• First Posted: November 5, 2013
• Results First Submitted: February 1, 2017
• Results First Posted: June 26, 2017
• Last Update Posted: October 14, 2021