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
The Family Involvement intervention has been developed from existing approaches called Trialogue and Psychoeducation. A key part of these approaches is bringing together several people living with mental health difficulties, their family members and mental health professionals into regular meetings. These different groups meet as equals to discuss topics that they have previously agreed on, share experiences and to learn from one another.
This study aims to find out whether Family Involvement can help to improve care for people living with severe mental illness in Uganda. More specifically, we want to find out how patients, family members/friends, and health professionals experience Family Involvement when it is used on a regular basis. We also want to find out if Family Involvement improves outcomes like quality of life and symptoms of patients and reduces the burden experienced by family members.

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 Family Involvement intervention and 30 patients will be recruited to a control condition, against which patient outcomes will be compared.
Patients who are recruited into the Family Involvement intervention will receive this at their routine clinic or agreed community location once per month. 1-2 family members/friends will be recruited for each patient, who will attend the monthly Family Involvement meetings with their relatives. 6-12 clinicians will be recruited to help facilitate the Family Involvement meetings. The Family Involvement intervention is based on principles of Trialogue and psychoeducation. It involves bringing together several patients, 1-2 of their family members/friends and 1-2 mental health professionals in monthly meetings, as equals so that they may discuss pre-agreed topics, share experiences and for mutual learning.
Patients recruited to 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. Family members and friends might benefit from having space to share their experiences and learn from other patients and families, which might lead to an improved ability to provide care for their family member or friend with 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. Masaka Regional Referral Hospital, Alex Ssebowa Road, Masaka, 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 Family Involvement in severe mental illness in Uganda: a non-randomised controlled trial

Acronym

Study hypothesis

To test the acceptability, feasibility and effectiveness of Family Involvement against usual treatment.
The specific research questions are:
1. How can Family Involvement be used to support community mental health care in Uganda?
2. How is Family Involvement experienced by patients, family members/friends and professionals?
3. How do outcomes change when Family Involvement 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 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 Family Involvement intervention and 30 patients will be recruited to a control condition, against which patient outcomes will be compared.

Patients who are recruited into the Family Involvement intervention will receive this at their routine clinic or agreed community location once per month. 1-2 family members/friends will be recruited for each patient, who will attend the monthly Family Involvement meetings with their relatives. 6-12 clinicians will be recruited to help facilitate the Family Involvement meetings. The Family Involvement intervention is based on principles of Trialogue and psychoeducation. It involves bringing together several patients, 1-2 of their family members/friends and 1-2 mental health professionals in monthly meetings, as equals so that they may discuss pre-agreed topics, share experiences and for mutual learning.

Patients recruited to 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. Objective social functioning, measured using Objective Social Outcome Index (SIX) at baseline, 6 and 12 months
2. Symptoms, measured using Brief Psychiatric Rating Scale (BPRS) 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
5. Medication adherence, measures using the Medication Adherence Rating Scale (MARS) at baseline, 6 months 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. Patients with a primary diagnosis of severe mental illness (ICD-10 F20-29, F31, F32)
2. Aged 18-65 years
3. Capacity to provide informed consent assessed by UBACC Score of ≥14;
4. Able to communicate in Luganda or English
5. Can identify a family member or friend
6. Scores 5 or below on the MANSA scale

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients in Family Involvement Intervention (30-60 family members/friends; 6-12 clinicians) and 30 control patients

Total final enrolment

87

Participant exclusion criteria

1. Primary diagnosis of substance-use disorder; organic psychosis and/or neurocognitive disorder
2. Currently an inpatient at the time of recruitment
3. 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

Uganda

Trial participating centre

Masaka Regional Referral Hospital
Alex Ssebowa Road
Masaka
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://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

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 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.
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

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