Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Group Medical Visits
BehavioralGroup 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Standard client servicesNo intervention 0 interventions
Group B: Virtual outpatient careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Month 3 and month 6 of intervention2
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.
Time frame
Baseline, during the intervention, through study completion (estimation 9 months)3
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.
Time frame
Month 6 of interventionSecondary outcomes
1
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.
Time frame
Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention2
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.
Time frame
Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention3
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.
Time frame
Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention4
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.
Time frame
Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of interventionSponsors and contacts
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Source ClinicalTrials.gov