Feasibility, effectiveness, and experiences of music workshops for adolescents with anxiety and depression
| ISRCTN | ISRCTN50583823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50583823 |
| Secondary identifying numbers | MR/S03580X/1 |
- Submission date
- 18/03/2022
- Registration date
- 21/04/2022
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
Anxiety and depression are frequent among adolescents in deprived areas of large cities in Latin America. However, findings suggest that about 50% of affected adolescents recover after one year. This raises the question as to which personal and social resources they use and help them to overcome the episodes of mental distress.
The OLA study (ISRCTN99961401) includes a longitudinal cohort study addressing the above question and assessing potentially helpful activities such as participation in music groups. However, the design of the cohort study is observational and does not involve an experimental variation of activities.
We will conduct a trial within a cohort study, where adolescents in Bogota (Colombia) already participating in the OLA longitudinal cohort study will randomly be assigned to either attend a music workshop or no additional treatment. The trial will test the feasibility, effectiveness, and experiences of a music workshop in reducing symptoms of anxiety and/or depression in adolescents in Bogota (Colombia). Whilst there is evidence for the effectiveness of music therapy groups, this trial tests the helpful potential of music groups that have not been designed as therapy and could be more appealing to adolescents.
Who can participate?
Adolescents who are already enrolled in the OLA longitudinal cohort study (aged 15-16 years old at the time of initial recruitment), with symptoms of anxiety and/or depression at recruitment to the OLS study and the study's 6-month follow-up.
What does the study involve?
The music workshop will follow a program developed and practiced by Fundación Batuta, offering an opportunity for adolescents to learn, practice, and enjoy music using simple musical repertoires that will allow them to develop listening, rhythmic, and singing skills, and the creative ability to make their own musical piece. The workshop will consist of a total of five sessions, each session lasting approximately 90 min, once per week, for five weeks.
40 adolescents (15-16 years old) who participated in the 6-month follow up for the OLA longitudinal cohort study and still reported symptoms of anxiety and/or depression will be randomly selected and allocated to attend the music workshop (intervention group); the remaining participants in the OLA study will not receive any additional treatment (control group).
Before the first workshop, participants will complete questionnaires about their experiences of symptoms of anxiety and depression. At the end of the music workshop program, participants will again complete the questionnaires and answer five open-ended exit questions about what they enjoyed and disliked, what they found helpful and unhelpful in the workshop, and in what way – if any – they benefited from the workshops.
What are the possible benefits and risks of participating?
This study will aim to provide evidence on whether arts activities in the community reduce the mental distress of adolescents. It will also build research capacity within Colombia and foster collaboration between an established university and a community music organization. A potential benefit for participants involved in the research is that they will be enabled to participate in musical activities which otherwise might be difficult to access and that their suggestions and experiences might be incorporated into further adaptations, which will tailor the intervention to their needs.
We do not foresee any significant ethical, legal, or management issues arising from this study.
Where is the study run from?
The study will take place in Bogotá, the capital city of Colombia. Queen Mary University of London (UK) is the coordinating centre with local PI from Pontificia Universidad Javeriana (Colombia) assuming responsibility for research activities in their country.
When is the study starting and how long is it expected to run for?
From December 2021 to July 2022
Who is funding the study?
The Medical Research Council (UK) and Global Challenges Research Fund (UK)
Who is the main contact?
Natalia Godoy Casasbuenas: natalia.godoy@javeriana.edu.co
Dr Carlos Gómez-Restrepo: cgomez@javeriana.edu.co
Professor Stefan Priebe: stefan.priebe2@nhs.net
Contact information
Principal Investigator
Cra. 7 # 40-62
Bogotá
110231
Colombia
 ORCID ID |
0000-0002-9013-5384 |
|---|---|
| Phone | +57 601 3208320 ext 2770 |
| cgomez@javeriana.edu.co |
Principal Investigator
Newham Centre for Mental Health, London E13 8SP
London
E13 8SP
United Kingdom
| ORCID ID |
0000-0001-9864-3394 |
|---|---|
| Phone | +44-(0)20-75404210 |
| stefan.priebe2@nhs.net |
Scientific
Cra. 7 # 40-62
Bogota
110231
Colombia
| ORCID ID |
0000-0002-1262-6436 |
|---|---|
| Phone | +57 3185581201 |
| natalia.godoy@javeriana.edu.co |
Study information
| Study design | Randomized controlled Trial Within a Cohort study (TWIC) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Feasibility, effectiveness, and experiences of music workshops for adolescents with anxiety and depression, a Trial Within a Cohort Study as part of the research program: ‘Building resilience and resources to reduce depression and anxiety in young people from urban neighborhoods in Latin America (OLA)’ |
| Study objectives | 1. How effective is the music workshop in reducing symptoms of anxiety and/or depression in adolescents? 2. How feasible are music workshops as an intervention for adolescents with anxiety and/or depression? 3. How is the music workshop experienced by adolescent participants? |
| Ethics approval(s) | Approved 18/02/2022, the Pontificia Universidad Javeriana Faculty of Medicine Institutional Research and Ethics Committee (Comité de Investigaciones y Ética Institucional (CIEI), Carrera 7a # 40-62, Piso 2, Bogotá, Colombia; +57-1 3208320 ext.2770; ciei@husi.org.co), ref: FM-CIE-0097-22 |
| Health condition(s) or problem(s) studied | Adolescents with symptoms of depression and anxiety |
| Intervention | This Trial Within a Cohort study (TWIC) is nested within a large cohort study that recruited participants with the condition of interest and follows them up over a period of time. Participants from this cohort are then selected as participants for the RCT to evaluate an intervention. Outcomes for the whole cohort are measured repeatedly, providing longitudinal information about the progression of the condition both for participants in the control group and those having the trial intervention. All participants in the adolescent cohort in Bogota who still have symptoms of anxiety and/or depression at the 6-month follow-up of the longitudinal cohort study and meet the eligibility criteria will be included in the trial. They will then be randomly assigned to the control group (no treatment) or music workshop (intervention group). There will be a total of two music workshops taking place, following the same programmme that is developed and practiced by Fundación Batuta. The programme will offer an opportunity for adolescents to learn, practice and enjoy music using simple musical repertoires that will allow them to develop listening, rhythmic and singing skills, and the creative ability to make their own musical piece Each workshop will include a total of five sessions, each lasting approximately 90 min with a potential break. The workshops will take place once a week, for five weeks. Each workshop will be led by a music teacher and a logistics support staff, from Fundación Batuta. Before the first workshop, participants will complete the patient health questionnaire (PHQ-8) and the generalised anxiety disorder assessment (GAD-7) questionnaire. After the end of the intervention, participants will again complete the PHQ-8 and GAD-7 questionnaires and answer five open-ended exit questions about what they enjoyed and disliked, what they found helpful and unhelpful in the workshop and in what way – if any – they may benefit from them. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 14/02/2024: Effectiveness measured using self-rated depression/anxiety symptoms by the patient health questionnaire (PHQ-8) and the generalised anxiety disorder assessment (GAD-7) questionnaire at the beginning (baseline) and five (5) weeks Previous primary outcome measure as of 06/05/2022 to 14/02/2024: Effectiveness measured using the patient health questionnaire (PHQ-8) and the generalised anxiety disorder assessment (GAD-7) questionnaire at 12-months follow-up, adjusted for the 6-months follow-up scores, of intervention and control group, supplemented with pre-post intervention changes (baseline and 5 weeks) of self-rated depression/anxiety symptoms as measured by PHQ-8 and GAD-7 Previous primary outcome measure: Effectiveness measured using the patient health questionnaire (PHQ-8) and the generalised anxiety disorder assessment (GAD-7) questionnaire at baseline and 5 weeks |
| Secondary outcome measures | 1. Feasibility measured using the acceptance of workshop participation and attendance of workshop sessions at 5 weeks 2. Experiences measured using open-ended exit questions at 5 weeks |
| Overall study start date | 01/12/2021 |
| Completion date | 24/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 35 |
| Key inclusion criteria | All participants: 1. Enrolled in the OLA longitudinal cohort study 2. Aged 15-16 years when recruited to the OLA study 3. Symptoms of anxiety and/or depression at baseline and 6-month follow-up during the OLA study Intervention group only: 1. Capacity to provide assent 2. Informed consent provided by a parent/guardian |
| Key exclusion criteria | 1. Already regularly participate in a music band/orchestra, or have advanced music skills as determined during baseline assessment 2. Expressed no interest in participating in any arts activities during baseline assessment |
| Date of first enrolment | 07/05/2022 |
| Date of final enrolment | 14/05/2022 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Bogota
110211
Colombia
Sponsor information
University/education
Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 5555 |
|---|---|
| jrmo-helpdesk-smdpostaward@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)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- GCRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The aim of the dissemination activities will be to communicate findings in order to inform research, policy and practice. Target audiences include (but are not restricted to) adolescents and young people, policymakers, service managers, NGOs, education, health and youth organisations, charities and the public. Dissemination activities that we are already doing as part of the main OLA study, will also be used to disseminate the results from the TWIC (i.e. OLA study website, social media platforms, newsletter etc.). |
| IPD sharing plan | After the publication of the main findings, the researchers will operate an open data policy, following the FAIR principles e.g. Findable, Accessible, Interoperable, and Reusable. The anonymized datasets generated during and/or analyzed during the current study will be available from the CI (Stefan Priebe: stefan.priebe2@nhs.net) and the local PI (Carlos Gomez-Restrepo: cgomez@javeriana.edu.co) on reasonable request. During the course of the study, data will be shared internally within the study using an online data collection platform called REDCap. The method for sharing the data externally (if required and only after the publication of the findings that reflect the given data) will be decided in due course. Informed consent will be obtained from all participants involved in the study. All participants are assigned a participant 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. The de-identified data generated during and/or analysed during the current study will be shared, for e.g. in online databases, for research purposes upon reasonable request from the CI (Stefan Priebe: stefan.priebe2@nhs.net) and the local PI (Carlos Gomez-Restrepo: cgomez@javeriana.edu.co) and depending on a data sharing agreement. Informed consent regarding further sharing of de-identified data for future research purposes is obtained from all participants at the point of enrolment in the cohort. Informed consent for participation in music workshops will be obtained from all participants assigned to the intervention group of the trial within the cohort. During the course of the study, data will be shared internally within the study using an online data collection platform called REDCap. The type of data will be qualitative and quantitative. Research data will be retained and archived in accordance with the Research Governance Framework and IM&T Information and security policies. Records will be archived as per Queen Mary University of London procedures and kept for 20 years. The study CI (Priebe) will be the custodian of the data. The data collected in Colombia will also be stored at the main study site in Pontificia Universidad Javeriana, and Dr Carlos |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 09/02/2022 | 04/04/2022 | No | No |
| Results article | 02/12/2024 | 03/12/2024 | Yes | No |
Additional files
Editorial Notes
03/12/2024: Publication reference added.
14/02/2024: The following changes have been made:
1. The overall study end date has been changed from 29/02/2024 to 24/06/2022.
2. The primary outcome measure was changed.
3. The total final enrolment was added.
4. The recruitment end date was changed from 30/09/2023 to 14/05/2022.
02/10/2023: A study contact email address was amended throughout the record.
06/05/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/04/2022 to 07/05/2022.
2. The recruitment end date has been changed from 30/04/2022 to 30/09/2023.
3. The overall trial end date has been changed from 21/05/2022 to 29/02/2024 and the plain English summary has been updated accordingly.
4. The primary outcome measure has been updated.
04/04/2022: Trial’s existence confirmed by the Pontificia Universidad Javeriana Faculty of Medicine Institutional Research and Ethics Committee.
