Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

NCT ID: NCT06651801

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard client services

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual outpatient care

Group Type: EXPERIMENTAL

Group Medical Visits

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Penner-Goeke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PsycHealth Centre

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kirsten Penner-Goeke, MD

Role: CONTACT

kpennergoeke2@hsc.mb.ca

204-787-7949

Facility Contacts

Kirsten Penner-Goeke, MD

Role: primary

kpennergoeke2@hsc.mb.ca

204-787-7949

Other Identifiers

HS26533

Identifier Type: -

Identifier Source: org_study_id