NCT04445324

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 23, 2020

Status Verified

October 1, 2020

Enrollment Period

Same day

First QC Date

June 22, 2020

Last Update Submit

November 19, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

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

    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.

    14 weeks

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

    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.

    14 weeks

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

    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.

    14 weeks

Secondary Outcomes (6)

  • 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 : alcohol dependence (clinical recovery)

    14 weeks

  • Assessment of patients' current status : drug dependence (clinical recovery)

    14 weeks

  • Assessment of patients' current status : psychosis (clinical recovery)

    14 weeks

  • +1 more secondary outcomes

Study Arms (2)

Transitional Online Peer Support Group (n=20)

EXPERIMENTAL

Trained Peer Support Workers (PSWs) from the Quebec Association of PSWs will organize and facilitate two series (one per condition) of 10 co-learning recovery workshops in a manner to simulate a typical peer support group. The difference of these transitional peer support groups to real community-based peer support groups is that (A) they will be facilitated by trained PSW, (B) they will have a personal-civic recovery focus, and (C) they will have a fixed, predetermined duration (10 weekly 60 to 90-minute online workshops). Typical Peer support groups bring together people who have similar concerns so they can explore solutions to overcome shared challenges and feel supported by others with similar experiences and who may better understand each other's situation. Peer support groups should ideally be independent from mental health and social services, although some services may facilitate and encourage the creation of (transitional) peer support groups, as is the case here. (WHO)

Behavioral: Transitional Online Peer Support Group (n=20)Other: Control Group (pharmacotherapy and/or psychotherapy, n=10)

Control Group (pharmacotherapy and/or psychotherapy N=10)

ACTIVE COMPARATOR

When individuals show up at the Emergency Department (T1) of the Montreal Mental Health University Institute, 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 for an appointment (T3). Whether for (a) psychotic disorders or for (b) 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.

Other: Control Group (pharmacotherapy and/or psychotherapy, n=10)

Interventions

Trained Peer Support Workers (PSWs) from the Quebec Association of PSWs will organize and facilitate two series (one per condition) of 10 co-learning recovery workshops in a manner to simulate a typical peer support group. The difference of these transitional peer support groups to real community-based peer support groups is that (A) they will be facilitated by trained PSW, (B) they will have a personal-civic recovery focus, and (C) they will have a fixed, predetermined duration (10 weekly 60 to 90-minute online workshops). Typical Peer support groups bring together people who have similar concerns so they can explore solutions to overcome shared challenges and feel supported by others with similar experiences and who may better understand each other's situation. Peer support groups should ideally be independent from mental health and social services, although some services may facilitate and encourage the creation of (transitional) peer support groups, as is the case here. (WHO)

Transitional Online Peer Support Group (n=20)

When individuals show up at the Emergency Department (T1) of the Montreal Mental Health University Institute, 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 for an appointment (T3). Whether for (a) psychotic disorders or for (b) 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.

Control Group (pharmacotherapy and/or psychotherapy N=10)Transitional Online Peer Support Group (n=20)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CR-IUSMM

Montreal, Quebec, H1N 3M5, Canada

Location

Related Publications (1)

  • Pelletier JF, Houle J, Goulet MH, Juster RP, Giguere CE, Bordet J, Henault I, Lesage A, De Benedictis L, Denis F, Ng R. Online and Recovery-Oriented Support Groups Facilitated by Peer Support Workers in Times of COVID-19: Protocol for a Feasibility Pre-Post Study. JMIR Res Protoc. 2020 Dec 18;9(12):e22500. doi: 10.2196/22500.

Related Links

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jean-Francois Pelletier, PhD

    Research Centre - Montreal Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dpt of Psychiatry and Addictologye, University of Montreal

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

August 25, 2020

Primary Completion

August 25, 2020

Study Completion

December 1, 2020

Last Updated

November 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations