Condition category
Mental and Behavioural Disorders
Date applied
01/03/2019
Date assigned
04/03/2019
Last edited
05/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Volunteer Support involves a volunteer, such as a student or member of the community, spending time with a person living in the community with mental health difficulties. Two volunteers will meet small groups of three to six patients, meeting every 2 week for a period of 6 months, with a focus on increasing social activities/interactions e.g. visiting parks, museums, and going to cafes. As music and art plays a strong role in the Colombian culture, the social activities may involve producing art and music.
This study aims to find out whether Volunteer Support can help to improve care for people living with severe mental illness in Colombia. More specifically, we want to find out how patients and volunteers experience Volunteer Support when it is used on a regular basis. We also want to find out if Volunteer Support improves outcomes like quality of life and symptoms.

Who can participate?
Anyone with a primary diagnosis of severe mental illness (ICD-10 F20-29, F31, F32) who is aged 18-65 years.

What does the study involve?
30 patients will be recruited and will receive the Volunteer Support intervention, where 2 volunteers will meet small groups of 3-6 patients every 2 weeks for 6 months. The focus of this intervention is to increase social activities and interactions e.g. visiting parks, museums, and going to café. As music and art play a strong role in the Colombian culture, the social activities may involve producing art and music.

What are the possible benefits and risks of participating?
Severe mental illnesses cause high levels of distress to affected individuals. In countries such as Colombia there is often a lack of human and financial resources for specialised mental health services in the community. This study will provide evidence on how to include effective and long-lasting local based interventions for community based mental health programs in the country. Overall, the study will build both mental health and research capacity within Colombia.
Additionally, for patients who will be involved in testing the intervention, this might lead to improved quality of life, social functioning, and symptom reduction. Volunteer participants might gain experience and knowledge about supporting someone with mental illness which might reduce stigma towards mental illness.
We do not predict any significant risks from participating in this study; however it is possible that whilst completing the research assessments or qualitative interviews, the questions asked might trigger feelings of distress or anxiety. To minimise this risk; researchers with experience working with severe mental illness were employed and trained, research assessments can be stopped at any point, and further support can be provided to the participant if necessary.

Where is the study run from?
1. Clinica La Inmaculada, Cra. 7 #6970, Bogotá, Cundinamarca, Colombia
2. San Ignacio University Hospital, Cra. 7 #40-62, Bogotá, Cundinamarca, Colombia
3. ACPEF (Colombian Association of Schizophrenia Patients and their Families), cl.52a #27a-54, Bogotá, Cundinamarca, Colombia
4. Asociación Colombiana de Bipolares, Carrera 8 D No. 106 - 50 Barrio Francisco Miranda, Bogotá, Cundinamarca, Colombia

When is the study starting and how long is it expected to run for?
December 2018 to March 2019

Who is funding the study?
National Institute for Health Research

Who is the main contact?
Ms. Erin Burn, e.burn@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Erin Burn

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2344
e.burn@qmul.ac.uk

Type

Scientific

Additional contact

Ms Sana Sajun

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
s.sajun@qmul.ac.uk

Type

Scientific

Additional contact

Ms Catherine Fung

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
c.fung@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

16/137/97

Study information

Scientific title

Testing the effectiveness, acceptability and feasibility of Volunteer Support in severe mental illness in Colombia: A non-controlled trial

Acronym

Study hypothesis

To test the acceptability, feasibility and effectiveness of Volunteer Support.
The specific research questions are:
1. How can Volunteer Support be used to support community mental care in Colombia?
2. How is Volunteer Support experienced by patients and volunteers?
3. How do patient outcomes change when Volunteer Support is used?

Ethics approval

1. IRB of Javeriana University, approved 19/09/2018, Ref: 2018/122
2. Ethics Committee of the Hospital Departamental Psiquiátrico Universitario del Valle, Cali, approved 08/10/2018
3. Ethics Committee of Clínica La Inmaculada, approval 16/07/2018
4. Ethics Committee of Clínica Fray Bartolomé: approval 14/11/2018
5. Queen Mary Ethics of Research Committee (Hazel Covill, Room W117, Finance Department, Queens’ Building, Queen Mary University of London, Mile End Road, London E1 4NS; 020 7882 7915; h.covill@qmul.ac.uk): approved 30/10/2018, Ref: QMERC2018/59

Study design

Interventional multi-centre non-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients with severe mental illness (including psychosis)

Intervention

30 patients will be recruited and will receive the Volunteer Support intervention, where 2 volunteers will meet small groups of 3-6 patients every 2 weeks for 6 months. The focus of this intervention is to increase social activities and interactions e.g. visiting parks, museums, and going to café. As music and art play a strong role in the Colombian culture, the social activities may involve producing art and music.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Quality of Life, measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline, 6 months and 12 months.

Secondary outcome measures

1. Symptoms, measured using the Brief Psychiatric Rating Scale (BPRS) at baseline, 6 and 12 months
2. Objective social situation, measured using the Objective Social Outcomes Index (SIX) at baseline, 6 and 12 months
3. Service use, measured using adapted Client Service Receipt Inventory (CSRI) at baseline, 6 and 12 months.
4. Stigma, measured using the Internalized Stigma of Mental Illness Inventory (ISMI) at baseline, 6 and 12 months.

Overall trial start date

01/08/2017

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary diagnosis of severe mental illness (ICD-10 F20-29, F31, F32)
2. Aged 18-65 years
3. Capacity to provide informed consent
4. Willing to engage with a volunteer
5. Scores 5 or below on the MANSA scale
6. Illness of over 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients (20 volunteers)

Total final enrolment

55

Participant exclusion criteria

1. Primary diagnosis of substance-use disorder
2. Diagnosis of dementia or organic psychosis;
3. An inpatient at the time of recruitment
4. Participating in another study conducted by this or another research group

Recruitment start date

01/12/2018

Recruitment end date

15/03/2019

Locations

Countries of recruitment

Colombia

Trial participating centre

Clinica La Inmaculada
Cra. 7 #6970
Bogotá
N/A
Colombia

Trial participating centre

San Ignacio University Hospital
Cra. 7 #40-62
Bogotá
N/A
Colombia

Trial participating centre

ACPEF (Colombian Association of Schizophrenia Patients and their Families)
cl.52a #27a-54
Bogotá
N/A
Colombia

Trial participating centre

Asociación Colombiana de Bipolares
Carrera 8 D No. 106 - 50 Barrio Francisco Miranda
Bogotá
N/A
Colombia

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Blizard Building
4 Newark St
Whitechapel
London
E1 2AT
United Kingdom
+44 (0)20 7540 4380 Ext:2312
s.sajun@qmul.ac.uk

Sponsor type

University/education

Website

https://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We intend to publish the quantitative and qualitative findings from this study by August 2020. Regarding dissemination, this study is part of a research group which also aims to build sustainable research capacity. The dissemination plan therefore aim to inform research, policy and practice. We plan to disseminate the findings across Colombia and across two wider networks, LatinCLEN and Red Maristan, that supports research and teaching of young mental health researchers across the region. Dissemination will include publications, attending conferences, and using platforms like Twitter and our Group website.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Stefan Priebe (s.priebe@qmul.ac.uk)
The data collected will be both quantitative and qualitative. The duration of availability of data has not yet been decided. During the course of the study, data will be shared internally within the Group using an online data collection platform called REDCap, for basic descriptive and comparative analysis. The method for sharing the data externally (if required) will be decided in due course.
Informed consent will be obtained from all participants involved in the study. All participants are assigned a patient ID at the point of enrolment and all subsequent data collected will be linked to this ID, without any link to identification data following Good Clinical Practice.

Intention to publish date

31/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: Final enrolment number added. 04/03/2019: Trial’s existence confirmed by IRB