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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06651801
- Acronym / sponsor ID
- HS26533
- Conditions
- Mental Health Care, Anxiety and Depression, Pilot Study
- Keywords
- Group Medical Visits, Anxiety, Depression, Shared Medical Appointments, Pilot Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard client services | No intervention | –Participants will follow-up with their primary care provider (family physician or nurse practitioner). |
| Virtual outpatient care | Experimental | Behavioral: Group Medical Visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Medical VisitsGroup 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. | Behavioural | Virtual outpatient care |
Primary outcome
Client Satisfaction Questionnaire-4 Scale (CSQ-4)
Time frame: Month 3 and month 6 of intervention
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.
Recruitment and Retention Rate
Time frame: Baseline, during the intervention, through study completion (estimation 9 months)
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.
Primary Care Provider Satisfaction with Psychiatric Care
Time frame: Month 6 of intervention
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.
4 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
General Anxiety Disorder-7 (GAD-7)
Time frame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Recovery Assessment Scale 24 (RAS24)
Time frame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Mental Health Quality of Life Questionnaire (MHQoL)
Time frame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 42050722Kordan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Penner-Goeke, MD (204-787-7949, kpennergoeke2@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-4 Scale (CSQ-4) (time frame: Month 3 and month 6 of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.