Condition category
Mental and Behavioural Disorders
Date applied
01/03/2019
Date assigned
04/03/2019
Last edited
04/03/2019
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 Colombia. 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 bass. We also want to find out if Family Involvement improves outcomes like quality of life and symptoms for patients.
We will therefore recruit 30 patients to take part in this study. Patients will attend meetings once per month over a 6 month period. In each group, there will be 5 patients, 1-2 family members/friends for each patient and 1-2 mental health professionals.
We will interview patients, family members/friends and clinicians at the end of the study to see how they experienced the intervention.

Who can participate?
Patients with a primary diagnosis of severe mental illness, aged 18-65 years can participate.

What does the study involve?
The Family Involvement Intervention will be tested in an open non-controlled trial with 30 patients. The patients will receive Family Involvement at an agreed community location once per month over a 6 month period. 1-2 family members/ friends will be recruited for each patient. These participants will attend the month 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 mutual learning.

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. 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. Clinica La Inmaculada, cra.7 #6970, Bogotá, Cundinamarca, Colombia
2. ACPEF (Colombian Association of Schizophrenia Patients and their Families), cl.52a #27a-54, Bogotá, Cundinamarca, Colombia
3. Asociación Colombiana de Bipolares, Carrera 8 D No. 106 - 50 Barrio Francisco Miranda, Bogotá, Cundinamarca, Colombia
4. San Ignacio University Hospital, cra.7 #40-62, 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, 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
Colombia
+44 (0)20 540 4380 Ext: 2312
s.sajun@qmul.ac.uk

Type

Public

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 Colombia: Non-Controlled Trial

Acronym

Study hypothesis

To test the acceptability, feasibility and effectiveness of Family Involvement.
The specific research questions are:
1. How can Family Involvement be used to support community mental health care in Colombia?
2. How is Family Involvement experienced by patients, family members/friends and professionals?
3. How do patient outcomes change when Family Involvement is used?

Ethics approval

1. IRB of Javeriana University, approved 19/09/2018, Ref: 2018/122
2. Ethics Committee of the University Hospital of Valle, approved 08/10/2018
3. Ethics Committee of Clínica La Inmaculada, approved16/07/2018
4. Ethics Committee of Clínica Fray Bartolomé: approved 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 multicentre 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

The Family Involvement Intervention will be tested in an open non-controlled trial with 30 patients. The patients will receive Family Involvement at an agreed community location once per month over a 6 month period. 1-2 family members/ friends will be recruited for each patient. These participants will attend the month 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 mutual learning.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Quality of Life, measured using the Manchester Short Assessment of Quality of Life (MANSA) measured 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

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 F20-29, F31, F32)
2. Aged 18-65 years old
3. Illness of 6 months or over
4. Scores 5 or below on the MANSA scale
5. Capacity to provide informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients (30-60 family members/ friends, 6-12 clinicians)

Participant exclusion criteria

1. Primary diagnosis of substance-use disorder
2. Diagnosis of dementia or organic psychosis
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

Colombia

Trial participating centre

Clinica La Inmaculada
cra.7 #6970
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

Trial participating centre

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

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Blizard Building
$ Newark St
Whitechapel
London
E1 2AT
United Kingdom
+44 (0)20 540 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 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

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

04/03/2019: Trial’s existence confirmed by IRB