Clinical trial NCT06651801: Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
Official title: A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Care
Anxiety and Depression
Pilot Study
Keywords: Group Medical Visits
Anxiety
Depression
Shared Medical Appointments
Pilot Study
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire-4 Scale (CSQ-4)
timeFrame: Month 3 and month 6 of intervention
measure: Recruitment and Retention Rate
timeFrame: Baseline, during the intervention, through study completion (estimation 9 months)
measure: Primary Care Provider Satisfaction with Psychiatric Care
timeFrame: Month 6 of intervention
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
measure: Recovery Assessment Scale 24 (RAS24)
timeFrame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
measure: Mental Health Quality of Life Questionnaire (MHQoL)
timeFrame: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: PsycHealth Centre
state: Manitoba
Study officials:
References: