Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT06651801

Conditions

Mental Health Care

Anxiety and Depression

Pilot Study

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Medical Visits

Study Details

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 ID

NCT06651801

Start date

Apr 15, 2025

Status verified date

Apr, 2025

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard client services

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

experimental: Virtual outpatient care

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.

Primary outcome measure

  • Client Satisfaction Questionnaire-4 Scale (CSQ-4) [ Time Frame: Month 3 and month 6 of intervention ]
  • Recruitment and Retention Rate [ Time Frame: Baseline, during the intervention, through study completion (estimation 9 months) ]
  • Primary Care Provider Satisfaction with Psychiatric Care [ Time Frame: Month 6 of intervention ]

Central Contacts and Locations

Central contacts

Kirsten Penner-Goeke, MD

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

Locations

PsycHealth Centre

Recruiting

Winnipeg, Manitoba, Canada, R3E 3N4

Contacts

Kirsten Penner-Goeke, MD

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

More Information

Sponsor

University of Manitoba

Last update posted

May 13, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-05-13.