Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

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:

• Are GMVs feasible and acceptable to patients with depression and anxiety?

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health Care; Pilot Study; Anxiety and Depression
• Intervention / Treatment: Behavioral: Group Medical Visits

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsten Penner-Goeke, MD; Phone Number: 204-787-7949; Email: kpennergoeke2@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3N4
      • Recruiting
      • PsycHealth Centre
      • Contact: Kirsten Penner-Goeke, MD; Phone Number: 204-787-7949; Email: kpennergoeke2@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult Central Intake patients (patients referred for psychiatric consultation by their primary care provider) whose primary mental health issue is an anxiety disorder (social anxiety, generalized anxiety, or panic disorder) or depression (major depressive disorder or persistent depressive disorder)
• Able to participate in English language group with up to 10 participants
• Able to commit to a virtual biweekly group for about 1.5 hours each group
• Able to do virtual group from a private location with camera access
• Live in community in Manitoba and plan to stay for 6-month period

Exclusion Criteria:

• Patients with Bipolar 1 or 2 Disorder (even if current episode depression)
• Primary diagnosis of a personality disorder leading to anxiety/depression symptoms (personality disorder traits are not an exclusion criteria)
• Patients who already have established longitudinal care with a psychiatrist
• Received ECT treatment within past 6 months
• Any diagnosis that would significantly impact ability to participate in the group. For example:
• Moderate-to-severe substance use disorders (in particular substance use throughout day or inability to attend group without using substances before)
• Current psychotic symptoms
• Moderate-to-severe intellectual disability or neurocognitive disorder
• Current significant eating disorder symptoms (for example resulting in significant weight loss/malnutrition or that take up a significant part of the day either mentally or physically)
• Self harm behaviour requiring medical/psychiatric attention or active suicidal ideation/suicide attempts within the past 6 months
• Concern about safety of other group members/facilitators if this patient were to join

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard client services; Participants will follow-up with their primary care provider (family physician or nurse practitioner).
Experimental: Virtual outpatient care	Behavioral: Group Medical Visits; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Shared Medical Appointments; Pilot Study; Group Medical Visits
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: HS26533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No