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 one or two of the following tasks i) increasing social activity/interactions; ii) engaging in productive, e.g. income-generating, activities; iii) providing practical support for accessing and utilising available professional services and care; and iv) referrals to such services if and when appropriate. It will be up to each group of patients and volunteers to decide which of these tasks to focus on.
This study aims to find out whether Volunteer Support can help to improve care for people living with severe mental illness in Uganda. 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 of patients.

Who can participate?
Patients with a primary diagnosis of severe mental illness, aged 18-65 years, able to communicate in Luganda or English can participate.

What does the study involve?
30 patients will be recruited to the Volunteer Support intervention and 30 patients will be recruited to a control condition, against which patient outcomes in Volunteer Support will be compared.
Patients who are recruited into the intervention group will receive Volunteer Support every 2 weeks over 6 months, where 2 volunteers will meet small groups of three to six patients. The intervention will focus on one or two of the following tasks i) increasing social activity/interactions; ii) engaging in productive, e.g. income-generating, activities; iii) providing practical support for accessing and utilising available professional services and care; and iv) referrals to such services if and when appropriate. It will be up to each group of patients and volunteers to decide which of these tasks to focus on.
Patients in the control group will receive their usual treatment over the 6 month period.

What are the possible benefits and risks of participating?
Severe mental illnesses cause high levels of distress to affected individuals. In countries such as Uganda 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 Uganda.
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, research assessments can be stopped at any point, and further support can be provided to the participant if necessary.
Participants may also experience anxiety in trying new interventions. Throughout the intervention-testing period, individuals will continue to receive their routine care, including any medication. The interventions can be stopped at any point.

Where is the study run from?
1. Jinja Regional Referral Hospital, Rotary Road, Jinja, Uganda
2. Mityana District Hospital, Masaka, Uganda

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, UK

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 Uganda: a non-randomised controlled trial

Acronym

Study hypothesis

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

Ethics approval

1. Makerere University College of Health Sciences, School of Medicine Research Ethics Committee, approved 19/09/2018, Ref: 2018-096
2. Uganda National Council for Science and Technology, approved on 01/11/2018, Ref: SS 4807
3. 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: QMERC2018/67

Study design

Interventional multi-centre non-randomised 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 to the Volunteer Support intervention and 30 patients will be recruited to a control condition, against which patient outcomes in Volunteer Support will be compared.

Patients who are recruited into the intervention group will received Volunteer Support every 2 weeks over 6 months, where 2 volunteers will meet small groups of three to six patients. The intervention will focus on one or two of the following tasks i) increasing social activity/interactions; ii) engaging in productive, e.g. income-generating, activities; iii) providing practical support for accessing and utilising available professional services and care; and iv) referrals to such services if and when appropriate. It will be up to each group of patients and volunteers to decide which of these tasks to focus on.

Patients in the control group will receive their usual treatment over the 6 month period.

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 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 Self-Esteem Rating Scale at baseline, 6 months and 12 months
5. Adherence to medication, using the Medication Adherence Rating Scale (MARS) 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 old and over
3. Capacity to provide informed consent assessed by UBACC score of ≥14
4. Able to communicate in Luganda or English
5. Scores 5 or below on the MANSA scale

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients and 10 volunteers in the intervention arm and 30 patients in the control arm

Total final enrolment

46

Participant exclusion criteria

1. Primary diagnosis of substance-use disorder, organic psychosis and/or a neurocognitive disorder
2. Currently an inpatient at the time of recruitment
3. Participating in another study conducted by this or another group

Recruitment start date

01/12/2018

Recruitment end date

15/03/2019

Locations

Countries of recruitment

Uganda

Trial participating centre

Jinja Regional Referral Hospital
Rotary Road
Jinja
N/A
Uganda

Trial participating centre

Mityana District Hospital
Mityana
N/A
Uganda

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

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://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

Federal/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 aims to inform research, policy and practice. We plan to disseminate findings across Uganda and across a broader, regional consortium, THRiVE, which operates across East and Central Africa, and which our PI in Uganda leads on. Dissemination will include publications, attending conferences, and using platforms like Twitter and out 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

The combined sets of all data from all countries will be held at QMUL in anonymised form. Data sharing with external interests will be considered only after the publication of the findings that reflect the given data. The datasets will be available upon request from 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

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: The total final enrollment has been added 04/03/2019: Trial’s existence confirmed by IRB