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

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients who are looking for longitudinal psychiatric follow-up after a one-time consult or discharge from a mental health program.
  • Primary mental health issue is an anxiety or depressive disorder.
  • Able to commit to a virtual biweekly group on Tuesdays from 2:30-4PM.
  • Able to do virtual group from a private location with camera access.
  • Live in community in Manitoba and plan to stay for a 6-month period.

Exclusion Criteria:

  • Patients with confirmed Bipolar 1 or 2 Disorder.
  • Patients who already have longitudinal care with a psychiatrist.
  • Received ECT treatment within past 6 months.
  • Concern about safety of other group members/facilitators if this patient were to join.
  • Any co-morbidity/behaviour that would significantly impact ability to participate in the group. For example:
  • Severe substance use disorder.
  • Significant PTSD or OCD symptoms that would impact group participation.
  • Severe personality disorder.
  • Current psychotic symptoms.
  • Moderate to severe intellectual disability or neurocognitive disorder.
  • Current significant eating disorder symptoms.
  • Self-harm behaviour requiring medical/psychiatric attention or suicide attempt within the past 6 months.

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

Oct 14, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.