Mental Health Care, Anxiety and Depression, Pilot Study
Conditions
Keywords
Group Medical Visits, Anxiety, Depression, Shared Medical Appointments, Pilot Study
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.
Interventions
BEHAVIORALGroup 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.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire-4 Scale (CSQ-4) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention | Includes 9 items assessing depressive symptom severity. Total score ranges from 0 to 20, with a higher score indicating higher symptom severity. |
| Mental Health Quality of Life Questionnaire (MHQoL) | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention | Consists of 7 domains with 4 items assessing each. Total score ranges from 0 to 21, with higher scores indicating better quality of life. |
| General Anxiety Disorder-7 (GAD-7) | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention | Includes 7 items assessing anxiety symptom severity. Total score ranges from 0 to 21, with a higher score indicating higher symptom severity. |
| Recovery Assessment Scale 24 (RAS24) | Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention | Includes 24 items assessing personal recovery. Total score ranges from 24 to 120, with higher scores indicating higher levels of recovery. |
Countries
Canada
Contacts
Primary ContactKirsten Penner-Goeke, MD
Outcome results
None listed