BRiCs: Improving the quality of life for adolescents with mental health problems in Colombia
| ISRCTN | ISRCTN13980767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13980767 |
- Submission date
- 01/03/2022
- Registration date
- 18/03/2022
- Last edited
- 14/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and anxiety are common mental health problems affecting one in four people at some point in their lives. The number of people who experience depression and anxiety greatly increases during adolescence, particularly for those who experience stressful events. This includes adolescents who live in Low and Middle-Income Countries (LMICs). In fact, depression and anxiety are the top causes of disability for adolescents in LMICs. Despite the negative impact of depression and anxiety, a treatment gap exists. Less than half of people with depression and anxiety in LMICs access treatment. Even when people do get treatment, only a small proportion (20%) receive a minimum standard of care. This is often due to a lack of resources including enough specially trained staff and services to help people. Therefore, to improve health outcomes for adolescents with depression and anxiety, new approaches are needed. These new approaches need to be low-cost, effective, and have the potential to be used by a range of staff. We aim to achieve this goal.
DIALOG+ is an existing low-cost/cost-saving evidence-based therapeutically effective mental health intervention, which has been used and assessed in many clinical contexts internationally. During the initial phases of the project, we conducted focus groups and interviews to "repurpose" the intervention to ensure that it was suitable for adolescents. The new intervention is called DIALOG-A.
We will evaluate DIALOG-A in a cluster randomised controlled trial (RCT) conducted in two regions of Colombia - one deprived inner-city area and one rural location.
The overall aim is to improve health outcomes for adolescents with depression and anxiety in Colombia by adapting an existing effective intervention.
Who can participate?
Clinicians (aged 18 and over) who have regular contact with adolescents and adolescent patients (13-16 years old) with anxiety and/or depression from Bogotá and Duitama.
What does the study involve?
We will include 18 clinicians and 108 adolescents. 12 clinicians a72 adolescents will use DIALOG-A, and the remaining 6 staff and 36 adolescents will be in the control condition. To test whether DIALOG-A helps adolescents with depression and anxiety, we will ask participants to complete questionnaires at the start of the study and at 6 and 9 months. We will collect data on mental health outcomes, including symptoms of depression and anxiety, quality of life, social situation, and self-esteem.
What are the possible benefits and risks of participating?
Overall, the study will build both mental health and research capacity within Colombia. A potential benefit for all participants involved in the research, is that their suggestions and experiences might be incorporated into the adaption of DIALOG+ for use in an adolescent population. Additionally, for adolescents who will be involved in the testing of the modified intervention (DIALOG-A), this might lead to improved quality of life, social functioning, and symptoms. The project will also benefit the clinicians involved as they will be provided with training and supervision to enable them to implement the intervention.
The researchers do not predict any significant risks from participating in this study. All researchers will be trained in safe-guarding procedures and will be provided with on-going supervision in policies and procedures for, and in working with, individuals who disclose risks of harm. All research activities will be completed by researchers with experience of working with people with mental health difficulties.
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, in addition to the test intervention, furthermore, the intervention can be stopped at any point.
Where is the study run from?
Pontificia Universidad Javeriana (Colombia)
When is the study starting and how long is it expected to run for?
December 2021 to November 2023
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Professor Victoria Bird
v.j.bird@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
| Phone | +44 (0)20 540 4380 |
|---|---|
| d.s.sureshkumar@qmul.ac.uk |
Principal Investigator
Unit for Social and Community Psychiatry
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0002-2053-7679 |
|---|---|
| Phone | +44 (0)20 540 4380 |
| v.j.bird@qmul.ac.uk |
Principal Investigator
Decano: Facultad de Medicina
Carrera 7 N.º 40 – 62 - piso 9
Ed. Hospital Universitario San Ignacio
Bogota
110231
Colombia
| Phone | +57 (0)1 3208320 Ext 2816 |
|---|---|
| cgomez@javeriana.edu.co |
Study information
| Study design | Multi-site cluster exploratory randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Building Resilience in adolescence – Improving quality of life for adolescents with mental health problems in Colombia |
| Study acronym | BRiCs |
| Study objectives | DIALOG-A can significantly improve outcomes for adolescents with anxiety and/or depression compared to usual care. |
| Ethics approval(s) | 1. Approved 05/06/2020, Queen Mary Ethics of Research Committee (Queen Mary University of London, Queens’ Building, Mile End Campus, Mile End Road, London, E1 4NS, UK; +44 (0)20 7882 7915; research-ethics@qmul.ac.uk), ref: QMER2020/13. 2. Approved 27/02/2020, Comíté de Investigaciones y Ética Institucional, Facultad de Medicina, Pontificia Universidad Javeriana (Institutional Research and Ethics Committee, Faculty of Medicine, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Carrera 7 # 40-62, piso 2, Bogotá, Colombia; +57 (0)1 3208320 Ext 277; ciei@husi.org.co), ref: Building resilience in adolescence – improving quality of life for adolescents with mental health problems in Colombia (BRiCs) 2019/183. |
| Health condition(s) or problem(s) studied | Adolescents with anxiety and/or depression |
| Intervention | Adolescents and clinicians will be recruited from at least three primary care/community health centres in the Bogota and Duitama municipalities. The unit of randomisation will be the clinicians, who will be randomised in a 2:1 ratio to either the intervention (DIALOG-A once per month over 6 months) or to the usual care control group (routine care, without DIALOG). The researchers will also collect data on effect estimates, variability, and recruitment and retention rates that would be required for a fully powered, definitive, efficacy trial. In the intervention group, clinicians and adolescents will use the repurposed DIALOG-A once per month over a 6-month period. Thereafter, they can use DIALOG-A flexibly depending on need. This will be documented and considered in the analysis. The intervention will be compared to a usual care control group. Clinicians in the active control will ask individuals to rate their quality of life on a tablet. This however will occur at the end of their meeting and will not involve a discussion of the ratings or the four-step solution-focused approach. |
| Intervention type | Behavioural |
| Primary outcome measure | Primary outcomes will be collected at baseline and 6 months: 1. Symptoms of depression measured using the Patient Health Questionnaire (PHQ- 8) at 6 months 2. Symptoms of anxiety measured using Generalised Anxiety Disorder assessment (GAD-7) at 6 months |
| Secondary outcome measures | All secondary outcomes are collected at baseline, 6 and 9 months (unless otherwise stated), for the 108 patient participants: 1. Depression on the PHQ-8 (at 9 months) 2. Anxiety on the GAD-7 (at 9 months) 3. Quality of life will be measured using Manchester Short Assessment Quality of Life (MANSA) 4. Mental health symptom levels (YP-CORE) 5. Social Support measured using the Multidimensional Scale of perceived Social Support 6. Empowerment measured using the Youth Efficacy/Empowerment scale 7. Self-esteem measured using the Rosenberg self-esteem scale 8. Economic outcomes measured using a modified Client Service Receipt Inventory (CSRI) |
| Overall study start date | 01/12/2021 |
| Completion date | 17/11/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 18 clinicians and 108 adolescents. |
| Total final enrolment | 149 |
| Key inclusion criteria | Clinicians: 1. Aged 18 years or over 2. Regularly sees adolescents with anxiety and/or depression 3. Experience of working with adolescents for at least 3 months 4. No plans to leave the current post within the next 6 months Patients: 5. Aged 13-16 years old 6. Currently experiencing depression or anxiety (defined as a score ≥7 on the Self-Reporting Questionnaire) 7. Capacity to provide informed assent and consent is provided by a parent/guardian |
| Key exclusion criteria | Clinicians: 1. Does not have regular contact with adolescents Patients: 2. Severe mental illness (psychosis, bipolar or schizophrenia) 3. Cognitive impairment and/or severe learning disability 4. Unable to provide informed assent and/or a parent/guardian does not provide consent |
| Date of first enrolment | 14/02/2022 |
| Date of final enrolment | 14/10/2022 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Pontificia Universidad Javeriana
Bogotá D.C.
110231
Colombia
Sponsor information
University/education
Facultad de Medicina
Carrera 7 N.º 40 – 62 - piso 9
Ed. Hospital Universitario San Ignacio
Bogota
110231
Colombia
| Phone | +57 (0)1 3208320 |
|---|---|
| echeverry.liliana@javeriana.edu.co | |
"ROR" |
https://ror.org/03etyjw28 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of the study results in a high-impact peer reviewed journal can be expected by the end of 2023. Study findings will be disseminated through a variety of mediums, including national and international meetings with clinicians, policy-makers and researchers, national workshops, end-of-study workshops, peer-reviewed journal articles, Twitter posts and updates on the project’s own website (http://bricsproject.com/). The researchers intend to publish a protocol paper in due course, none is available now. |
| IPD sharing plan | The project will operate an open research data policy, following the FAIR principles e.g. making the research data generated by the project Findable, Accessible, Interoperable and Reusable. At the same time, the research team will ensure that any sensitive data is not inappropriately accessed. The anonymised datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Carlos Gomez-Restrepo (cgomez@javeriana.edu.co). All data will be anonymised to protect confidentiality. Potentially identifiable data will be removed from the database, and aggregated data used where possible. Consent procedures will outline what data will be stored and how it may be shared. This will include outlining any current or potential future risks associated with data confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/02/2023 | 09/02/2023 | Yes | No |
Editorial Notes
14/05/2024: The overall study end date was changed from 27/09/2023 to 17/11/2023.
09/11/2023: The following changes were made to the study record:
1. The overall study end date was changed from 31/03/2023 to 27/09/2023.
2. The intention to publish date was changed from 31/12/2023 to 01/03/2024.
3. Total final enrolment added.
09/02/2023: Publication reference added.
16/06/2022: The recruitment end date has been changed from 14/06/2022 to 14/10/2022.
10/03/2022: Trial's existence confirmed by Pontificia Universidad Javeriana.
