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The goal of this clinical trial is to evaluate the feasibility and acceptability of the intervention, Group Medical Visits (GMVs), for patients with depression and anxiety. It also aims to get some initial information on the effectiveness of GMVs on reducing depression and anxiety scores, which will help inform power calculations for a future larger randomized controlled trial (RCT). The main question it aims to answer is:
This study consists of a pilot RCT with an intervention and control arm. At enrollment, participants will be randomized to the intervention group, 6 months of GMVs, or to the control group, which consists of "standard client services". For the GMV group, participants will engage in a biweekly virtual group that is similar to a standard psychiatric follow-up. Participants in the control group will receive standard care after a psychiatric assessment, which includes follow-up with their primary care provider (family physician or nurse practitioner), individual psychiatric care if suggested by the psychiatrist who did their psychiatric assessment, and/or a referral to publicly funded therapy groups if interested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard client services | No Intervention | Participants will follow-up with their primary care provider (family physician or nurse practitioner). | |
| Virtual outpatient care | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Medical Visits | Behavioral | Group medical visits occur every 2 weeks virtually (via Zoom) for 6 months. Each group consists of 45 minutes of group time and 5 minute individual check-in appointments. The group time consists of psychoeducation, group support, and medication follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire-4 Scale (CSQ-4) | Includes 4 items that measure client satisfaction. Items are rated on a 4-point scale, with total score ranging from 4 to 16. A higher score indicates higher satisfaction. | Month 3 and month 6 of intervention |
| Recruitment and Retention Rate | The investigators will examine the rates of how many participants sign up and are enrolled in the program, along with the drop-out rate throughout the program. | Baseline, during the intervention, through study completion (estimation 9 months) |
| Primary Care Provider Satisfaction with Psychiatric Care | The investigators will conduct a telephone survey with the primary care providers (PCPs) of the participants who were randomized to the intervention group. The survey will assess how satisfied the PCPs are with the care that their patient received during the trial. The survey consists of one question assessing overall satisfaction, rated on a 5-item scale from "Very Satisfied" to "Very Dissatisfied", two open ended questions assessing which aspects of care the PCPs were satisfied and not satisfied with, and 5 questions assessing whether they would refer other patients to the program, what benefits were there of having their patient in the program, and what aspects of the program could be improved. | Month 6 of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Includes 9 items assessing depressive symptom severity. Total score ranges from 0 to 20, with a higher score indicating higher symptom severity. | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention |
| General Anxiety Disorder-7 (GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Penner-Goeke, MD | Contact | 204-787-7949 | kpennergoeke2@hsc.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PsycHealth Centre | Recruiting | Winnipeg | Manitoba | R3E 3N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42050722 | Derived | Kordan C, Hensel J, Sareen J, Moody J, Alsaidi TH, Ayilara OF, Penner-Goeke K. A protocol paper for a pilot randomized controlled trial assessing the feasibility and acceptability of group medical visits for anxiety and depression in adults. Pilot Feasibility Stud. 2026 Apr 29;12(1):86. doi: 10.1186/s40814-026-01802-0. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Includes 7 items assessing anxiety symptom severity. Total score ranges from 0 to 21, with a higher score indicating higher symptom severity. |
| Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention |
| Recovery Assessment Scale 24 (RAS24) | Includes 24 items assessing personal recovery. Total score ranges from 24 to 120, with higher scores indicating higher levels of recovery. | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention |
| Mental Health Quality of Life Questionnaire (MHQoL) | Consists of 7 domains with 4 items assessing each. Total score ranges from 0 to 21, with higher scores indicating better quality of life. | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention |