跳至主要内容
临床试验/NCT04445324
NCT04445324Unknown不适用

Effects of Online and Recovery-oriented Peer Support Groups Facilitated by Peer Support Workers in Times of COVID-19 : A Feasibility Study of a Trial

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Assessment of patients' current status : COVID-19 Stress Scales

研究概览

简要总结

In times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery.

The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.

详细描述

The "signatures" of MHPIs is a term formulated by the American National Institute of Mental Health to designate the broad range of genetic, biological, psychological, and social factors that may "sign" a specific mental disorder, depending on an individual's sex, history, lifestyle habits, and so on. In 2010, the Research Centre of the Montreal Mental Health University Institute (MMHUI), in Canada, implemented the "Signature Bank" project for the collection of biological and psychosocial dimensional signatures from all psychiatric emergency patients of the MMHUI (catchment area of about 600,000 inhabitants). More than 4,000 patients are treated annually at the MMHUI, while an additional 2,000 patients per year are treated by means of outpatient or ambulatory services. Our activities provide us with one of the largest populations of patients with MHPIs in Canada. By collaborating with the MMHUI Research Centre, MMHUI-hospital managers have contributed to the implementation of this large-scale project that aims at measuring the (epi)genetic, biological, psychological, and social signatures of people living with MHPIs who receive the MMHUI's clinical services. Typically, these measures are obtained at four different points in the clinical visit of patients at the MMHUI: (T1) when patients are admitted to the psychiatric emergency services, (T2) when they are discharged from the hospital, (T3) when they are admitted to an outpatient clinic, and (T4) 12 months after T3. This study now goes even further in understanding not only the signature of MHPIs, but also the dimensions of personal-civic recovery and as reported by our patients who will additionally complete the Recovery Assessment Scale (7), the Citizenship Measure (8) and the COVID19 Stress Scales (9) components.

Several instruments have been developed by clinicians and academics to assess clinical recovery. Based on their life narratives and to assess personal-civic recovery, measurement tools have also been developed through community-based participatory research and validated by persons living with MHPIs; for instance the Recovery Assessment Scale and the Citizenship Measure questionnaires. As users of mental health services typically tend to prefer interventions to help them recover, reintegrate with society, and achieve their personal goals, this pre-post research feasibility trial design is undertaken to evaluate the outcomes on personal-civic recovery (primary outcome) and on clinical recovery (secondary outcome). Among the Signature Bank participants diagnosed with (a) psychotic disorders, or (b) anxiety and mood disorders, and who have further accepted to be invited to participate in this study, an half will only receive the corresponding control intervention, and the other half will also receive our experimental Peer Support Workers' online group intervention based on peer support (random allocation control/experimental intervention ratio = 2:1). The abovementioned additional measures of personal-civic recovery and the COVID19 Stress Scales will be repeated, along with the measures of clinical recovery, which are routinely collected among all Signature Bank participants.

The aim is to collect data for a future Randomized Controlled Trial design by clarifying a certain number of remaining uncertainties and by determining an effect size that would be specifically attributable to transitional online peer support groups as facilitated by trained PSWs. Analyses will thus also consider scientific reasons, processes, resources, and management in preparation for a more definitive trial. Indicators of feasibility will include recruitment rates practices, participants and facilitators, as well as feasibility and retention rates in study protocol.

When a person shows up at the Emergency Department of MMHUI for the first time, he or she is systematically approached by a Research Nurse after a first medical authorization is granted for that person to be approached (sometimes this authorization is not granted for medical or security reasons). The Research Nurse then explains what objectives of the Signature Bank project are and invites the person to participate. Those who accept sign the Information and Consent Form (T1), fill out a series of questionnaires, including for sociodemographic information, consent to the taking of biological samples, and they are also asked if they accept to be contacted for other research purposes (like our own study). Then, as with any other MMHUI patients, they are evaluated by the Evaluation and Liaison Module during their hospital stay when they are hospitalized. A diagnostic is established or confirmed by psychiatrists on the ward, and coded according to the World Health Organisation International Classification of Disease (ICD-10). According to these diagnoses, after discharge (T2) they are referred to a specialized outpatient clinic (T3). Whether for psychotic disorders or for anxiety and mood disorders, pharmacotherapy or psychotherapy, or a combination of both, are then offered in accordance with guidelines of the Royal College of Physicians and Surgeons of Canada.

PSWs will learn with participants via a series of co-learning workshops that they will organize and facilitate as focus group panels in a manner to simulate a typical peer support group. The difference of our experimental and transitional online peer support groups to real community-based peer support groups is that (A) they will have to be facilitated by trained PSWs and (B) they will have a personal-civic recovery focus. They will also (C) have a fixed, predetermined duration (a series of 10 weekly 90-minute online workshops), and this is why they are said to be transitional. Indeed, as defined by the World Health Organization: "Peer support groups bring together people who have similar concerns so they can explore solutions to overcome shared challenges and feel supported by others who have had similar experiences and who may better understand each other's situation. Peer support groups may be considered by group members as alternatives to, or complementary to, traditional mental health services. They are run by members for members so the priorities are directly based on their needs and preferences. Peer support groups should ideally be independent from mental health and social services, although some services may facilitate and encourage the creation of peer support groups" (10).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with (1) schizophrenia and psychotic disorders (ICD F20-F29), or
  • Patients diagnosed with (2) anxiety or mood disorders (ICD F30-F49)

排除标准

  • Active suicidal intentions
  • Marked cognitive impairment
  • No access to an electronic device with a webcam and microphone

结局指标

主要结局

Assessment of patients' current status : COVID-19 Stress Scales

时间窗: 14 weeks

Participating with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of COVID-related levels of stress. Minimum score = 0 : maximum score = 144.

Assessment of patients' current status : citizenship (personal recovery)

时间窗: 14 weeks

Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115.

Assessment of patients' current status : recovery (personal recovery)

时间窗: 14 weeks

Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120.

次要结局

  • Assessment of patients' current status : anxiety (clinical recovery)(14 weeks)
  • Assessment of patients' current status : depression (clinical recovery)(14 weeks)
  • Assessment of patients' current status : psychosis (clinical recovery)(14 weeks)
  • Assessment of patients' current status : alcohol dependence (clinical recovery)(14 weeks)
  • Assessment of patients' current status : drug dependence (clinical recovery)(14 weeks)
  • Assessment of patients' current status : social functioning (clinical recovery)(14 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Francois Pelletier

Associate Professor, Dpt of Psychiatry and Addictologye, University of Montreal

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

研究点 (2)

Loading locations...

相似试验