NCT01975948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

October 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

October 21, 2013

Results QC Date

February 1, 2017

Last Update Submit

September 20, 2021

Conditions

Keywords

Mental HealthEducation and Practice Support ProgramDepressionPrimary CareSkill-based trainingPatient centered outcomes

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 1, 2, 3, and 6 months

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

    The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.

    Baseline and at 6 months

Secondary Outcomes (1)

  • Between Group Changes in Occupational Functioning From Baseline to 6 Months

    Baseline, 1, 2, 3, and 6 months

Other Outcomes (7)

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

    Baseline and 6 months

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

    Baseline and 6 months

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

    Baseline and 6 months

  • +4 more other outcomes

Study Arms (4)

Mental Health PSP: Physicians

EXPERIMENTAL

Physicians training in Adult Mental Health Practice Support Program

Other: Mental Health Practice Support Program

Treatment as Usual: Physicians

ACTIVE COMPARATOR

Those administering treatment as usual for depression

Other: Treatment as Usual

Mental Health PSP: Patients

EXPERIMENTAL

Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.

Other: Mental Health Practice Support Program

Treatment as Usual: Patients

ACTIVE COMPARATOR

Those receiving treatment as usual for depression

Other: Treatment as Usual

Interventions

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

Mental Health PSP: PatientsMental Health PSP: Physicians

Physicians manage patients with depression as usual

Treatment as Usual: PatientsTreatment as Usual: Physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not currently under treatment for depression either with an antidepressant medication or psychotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University Department of Psychiatry

Halifax, Nova Scotia, B3H2E2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, MajorPsychological Well-BeingDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPersonal SatisfactionBehaviorBehavioral Symptoms

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.

Results Point of Contact

Title
Dr. Bianca Lauria-Horner
Organization
Dalhousie University, Department of Psychiatry

Study Officials

  • Bianca A Lauria-Horner, MD

    Associate Professor Dalhousie University Department of Psychiatry

    PRINCIPAL INVESTIGATOR
  • Scott Patten, FRCP(C), PhD

    Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Mental Healthcare Education Leader

Study Record Dates

First Submitted

October 21, 2013

First Posted

November 5, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 14, 2021

Results First Posted

June 26, 2017

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Results will be distributed through publications in academic journals and presented at upcoming conferences, study sponsors and contributors: i.e. the Mental Health Commission of Canada, the Nova Scotia Department of Health and Wellness, Dalhousie University, the University of Calgary, Doctors of Nova Scotia, study participants, etc. Study Protocol, SAP, and Informed Consent will be shared. However when SAP is checked below in IPD sharing field, it will not allow to be saved (check-mark in SAP does not remain when save button is clicked). De-identified patient data will not be shared as we made a commitment to physicians that only the PI would have access to this information, even though de-identified, some were concerned that patients could still be identified.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Available as of August 21/2017 till December 31/2017
Access Criteria
Contact: Bianca Lauria-Horner hornerb@dal.ca

Locations