A protocol paper for a pilot randomized controlled trial assessing the feasibility and acceptability of group medical
Christian Kordan1, Jennifer Hensel2, Jitender Sareen2
1Department of Psychiatry, University of Manitoba, Winnipeg, MB, Canada. kordanc@myumanitoba.ca.
Background:
Group medical visits (GMVs) offer a promising approach to address mental health challenges, particularly in settings with limited access to psychiatric care. Although GMVs have been studied in chronic disease management, their application in mental health, especially through randomized controlled trials (RCTs), remains sparse. This paper describes a study protocol for a pilot study evaluating GMVs as a potential solution to the high demand for mental health services exacerbated by long wait times and resource limitations.
Objectives:
This protocol paper for a pilot RCT aims to assess whether GMVs will be feasible and acceptable to patients. This pilot RCT will also collect implementation feedback from patients and primary care providers, as well as initial data on clinical outcomes to inform a potential future larger RCT of GMVs for mental health care.
Methods:
The pilot RCT will enroll 20 participants, randomized to either biweekly GMVs or resumed standard client services. The GMVs will consist of 45-min group sessions and 5-min individual check-ins, facilitated by a psychiatrist for 6 months. Data will be collected on recruitment rates and retention rates, as well as participant satisfaction using the Client Satisfaction Questionnaire-4 (CSQ-4). Clinical outcomes will be measured using the GAD-7, PHQ-9, Mental Health Quality of Life Scale (MHQoL), and Recovery Assessment Scale-24 (RAS-24). Primary care providers will be asked for feedback on their experience with GMVs versus standard client services as well at the end of the intervention.
Discussion:
This RCT protocol investigates GMVs as a potential solution to alleviate the strain on mental health services, which face long wait times and limited resources. By offering structured group sessions through GMVs, the study aims to enhance access to and quality of mental health care. Designed as an RCT due to limited existing evidence, the study will measure GMV feasibility, patient acceptability, and symptom response. If successful, this pilot study could provide a scalable model to improve accessibility, reduce costs, and enhance patient satisfaction in mental health care, particularly in resource-limited settings. TRIAL REGISTRATION {2A}: ClinicalTrials.gov, NCT06651801 . Registered 22 October 2024.
