Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

NCT06651801 | Recruiting

• 1 other identifier: HS26533
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Care; Anxiety and Depression; Pilot Study

Keywords

Group Medical Visits; Anxiety; Depression; Shared Medical Appointments; Pilot Study

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention

• General Anxiety Disorder-7 (GAD-7)

  Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention

• Recovery Assessment Scale 24 (RAS24)

  Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention

• Mental Health Quality of Life Questionnaire (MHQoL)

  Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention

Study Arms (2)

Standard client services

NO INTERVENTION

Participants will follow-up with their primary care provider (family physician or nurse practitioner).

Virtual outpatient care

EXPERIMENTAL

Behavioral: Group Medical Visits

Interventions

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.

Virtual outpatient care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with Bipolar 1 or 2 Disorder (even if current episode depression)
• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

PsycHealth Centre

Winnipeg, Manitoba, R3E 3N4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Kirsten Penner-Goeke, MD

CONTACT

204-787-7949; kpennergoeke2@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 22, 2024
• Study Start: April 15, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-04

Locations

CA (1)