Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Group 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.

Первичные конечные точки

• Client Satisfaction Questionnaire-4 Scale (CSQ-4) [Срок оценки: Month 3 and month 6 of intervention]
• Recruitment and Retention Rate [Срок оценки: Baseline, during the intervention, through study completion (estimation 9 months)]
• Primary Care Provider Satisfaction with Psychiatric Care [Срок оценки: Month 6 of intervention]

Вторичные конечные точки (4)

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention]
• General Anxiety Disorder-7 (GAD-7) [Срок оценки: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention]
• Recovery Assessment Scale 24 (RAS24) [Срок оценки: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention]
• Mental Health Quality of Life Questionnaire (MHQoL) [Срок оценки: Enrolment (before randomization), baseline (before intervention), month 3, and month 6 of intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 1 центр

• PsycHealth Centre — Winnipeg

Публикации

• 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. PMID 42050722

Идентификаторы

NCT: NCT06651801 · HS26533

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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