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NCT Number: NCT06651801

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.

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Key information

Conditions

Mental Health Care Anxiety Disorders Anxiety and Depression Behavior Behavioral Symptoms Depression Mental Disorders Pilot Study

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PsycHealth Centre

Winnipeg, Manitoba, R3E 3N4, Canada

Location status: Recruiting

Location contact

Kirsten Penner-Goeke, MD

CONTACT

[email protected]

204-787-7949

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group medical visits

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  2. General Anxiety Disorder-7 (GAD-7)

    Time frame: 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.

  3. Recovery Assessment Scale 24 (RAS24)

    Time frame: 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.

  4. Mental Health Quality of Life Questionnaire (MHQoL)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Penner-Goeke, MD

CONTACT

[email protected]

204-787-7949

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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