A research study in Colombia to test an intervention called Volunteer Support, designed to improve care for people living in the community with severe mental illness
| ISRCTN | ISRCTN72241383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72241383 |
| Secondary identifying numbers | 16/137/97 |
- Submission date
- 01/03/2019
- Registration date
- 04/03/2019
- Last edited
- 06/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 May 2020 (updated 03/03/2021, previously: March 2021)
Who is funding the study?
National Institute for Health Research
Who is the main contact?
Dr Francois van Loggerenberg, f.vanloggerenberg@qmul.ac.uk
Contact information
Scientific
Unit for Social and Community Psychiatry
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0001-5317-7983 |
|---|---|
| Phone | +44 (0)207 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
Public
Unit for Social and Community Psychiatry
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| ORCID ID |
0000-0001-5317-7983 |
|---|---|
| Phone | +44 (0)207 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
Study information
| Study design | Interventional multi-centre non-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Testing the effectiveness, acceptability and feasibility of Volunteer Support in severe mental illness in Colombia: A non-controlled trial |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2017 |
| Completion date | 13/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 patients (20 volunteers) |
| Total final enrolment | 55 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 15/03/2019 |
Locations
Countries of recruitment
- Colombia
Study participating centres
Bogotá
N/A
Colombia
Bogotá
N/A
Colombia
Bogotá
N/A
Colombia
Bogotá
N/A
Colombia
Sponsor information
University/education
Blizard Building
4 Newark St, Whitechapel
London
E1 2AT
England
United Kingdom
| Phone | +44 (0)20 7540 4380 Ext:2312 |
|---|---|
| s.sajun@qmul.ac.uk | |
| Website | https://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/05/2021 | 10/05/2021 | Yes | No | |
| Protocol article | 14/06/2019 | 11/08/2022 | Yes | No | |
| Protocol article | programme method | 13/09/2021 | 05/06/2024 | Yes | No |
Editorial Notes
05/06/2024: Publication reference added.
06/12/2022: A contact was removed.
11/08/2022: Publication reference added.
04/10/2021: The public and scientific contacts have been changed and the plain English summary updated accordingly.
10/05/2021: Publication reference added.
03/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2021 to 13/05/2020.
2. The plain English summary was updated to reflect these changes.
11/08/2020: The following changes have been made:
1. The overall trial end date has been changed from 31/07/2020 to 31/03/2021.
2. The intention to publish date has been changed from 31/10/2020 to 31/07/2021.
3. Two scientific contacts have been added.
4. The plain English summary has been updated to reflect the changes above.
05/04/2019: Final enrolment number added.
04/03/2019: Trial’s existence confirmed by IRB
