Mental Health CareNCT06651801
Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
A study testing Group Medical Visits in people with Mental Health Care and Anxiety and Depression, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Care, Anxiety and Depression, Pilot Study
- What is being tested?
- Group Medical Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
PsycHealth Centre
Winnipeg, Manitoba, R3E 3N4
Kirsten Penner-Goeke, MD, 204-787-7949, kpennergoeke2@hsc.mb.ca
About this study
Official title: A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
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
- Being tested
- Group Medical Visits
- Keywords
- Group Medical Visits, Anxiety, Depression, Shared Medical Appointments, Pilot Study
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Medical VisitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard client services | No intervention | Participants will follow-up with their primary care provider (family physician or nurse practitioner). |
| Virtual outpatient care | Experimental | Not described Receives: Behavioral: Group Medical Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 6 of intervention
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
Includes 9 items assessing depressive symptom severity. Total score ranges from 0 to 20, with a higher score indicating higher symptom severity.
Measured: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
General Anxiety Disorder-7 (GAD-7)
Includes 7 items assessing anxiety symptom severity. Total score ranges from 0 to 21, with a higher score indicating higher symptom severity.
Measured: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Recovery Assessment Scale 24 (RAS24)
Includes 24 items assessing personal recovery. Total score ranges from 24 to 120, with higher scores indicating higher levels of recovery.
Measured: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Mental Health Quality of Life Questionnaire (MHQoL)
Consists of 7 domains with 4 items assessing each. Total score ranges from 0 to 21, with higher scores indicating better quality of life.
Measured: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start15 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Penner-Goeke, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651801
- Sponsor's protocol ID
- HS26533
- Status last verified
- May 2026
- First submitted
- 7 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kordan C, Hensel J, Sareen J, Moody J, Alsaidi TH, Ayilara OF, Penner-Goeke K. A protocol paper for a pilot randomized controlled trial assessing the feasibility and acceptability of group medical visits for anxiety and depression in adults. Pilot Feasibility Stud. 2026 Apr 29;12(1):86. doi: 10.1186/s40814-026-01802-0.
PubMed 42050722