Feasibility, effectiveness and experiences of creativity workshops for young adults with anxiety and depression
| ISRCTN | ISRCTN95213581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95213581 |
| Secondary identifying numbers | MR/S03580X/1 |
- Submission date
- 26/05/2022
- Registration date
- 09/06/2022
- Last edited
- 11/11/2024
- 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 young adults in deprived areas of large cities in Latin America. However, findings suggest that about 50% of affected adolescents recover after 1 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 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. The researchers will conduct a trial within a cohort study where young adult participants in Buenos Aires (Argentina) and Lima (Peru), already participating in the OLA longitudinal cohort study, will randomly be assigned to a control group or a creativity workshop (intervention group). Thus, the trial will test the feasibility, effectiveness, and experiences of a creativity workshop in reducing symptoms of anxiety and/or depression in young adults in Buenos Aires and Lima. Whilst there is evidence for the effectiveness of art therapy groups, this trial tests the helpful potential of creativity workshops that have not been designed as therapy and could be more appealing to young adults.
Who can participate?
Young adults (20-24 years old when recruited for the cohort) who are already enrolled in the longitudinal cohort study, with symptoms of anxiety and/or depression at the start of the study and 6-month follow-up.
What does the study involve?
The creativity workshop will follow a program developed and led by Crear Vale la Pena (Buenos Aires) and Teatro La Plaza (Lima), offering an opportunity for youths to explore the concerns of young people at times of transition and the learnings from it. There will be a total of four workshops across the two sites: two in Buenos Aires and two in Lima, with 15 participants in each workshop. Each workshop will include a total of three in-person sessions, each lasting about 2-3 hours with a break.
Young adults who participated in the 6-month follow up, as part of the OLA longitudinal cohort study, and still reported symptoms of anxiety and/or depression will be randomly selected and allocated to the creative workshop (intervention group); the remaining participants in the OLA study will be the control group.
Before the first workshop, participants will complete questionnaires. After the end of the intervention, participants will complete the questionnaires again 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.
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 young adults. It will also build research capacity within Argentina and Peru and foster collaboration between established universities and arts organizations. A potential benefit for participants involved in the research is that they will be enabled to participate in creativity 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.
Where is the study taking place?
The study will take place in Buenos Aires (Argentina) and Lima (Peru). Queen Mary University of London (UK) is the coordinating centre with local researchers from Universidad de Buenos Aires and Universidad Peruana Cayetano Heredia taking accountability for the research activities conducted in their countries.
When is the study starting and how long is it expected to run for?
December 2021 to October 2023
Who is funding the study?
1. Medical Research Council (UK)
2. Global Challenges Research Fund (UK)
Who is the main contact?
1. Prof. Stefan Priebe (UK), stefan.priebe2@nhs.net
2. Dr Luis Brusco (Argentina), lbrusco@fmed.uba.ar
3. Mr Francisco Diez-Canseco (Peru), fdiezcanseco@upch.pe
4. Ms Liliana Hidalgo (Peru), liliana.hidalgo.p@upch.pe
Contact information
Principal Investigator
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0001-9864-3394 |
|---|---|
| Phone | +44 (0)20 75404210 |
| stefan.priebe2@nhs.net |
Principal Investigator
Jorge Newbery 3176
Buenos Aires
C1427EIB
Argentina
| ORCID ID |
0000-0002-1846-8686 |
|---|---|
| Phone | +54 (0)9 11 62188642 |
| lbrusco@fmed.uba.ar |
Principal Investigator
Avenida Armendáriz 446
Miraflores
Lima
15074
Peru
| ORCID ID |
0000-0002-7611-8190 |
|---|---|
| Phone | +51 (0)1 241 6978 |
| fdiezcanseco@upch.pe |
Public
Avenida Armendáriz 446
Miraflores
Lima
15074
Peru
| ORCID ID |
0000-0001-8451-7215 |
|---|---|
| Phone | +51 (0)995 533 202 |
| liliana.hidalgo.p@upch.pe |
Study information
| Study design | Trial Within a Cohort study (TWIC) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Feasibility, effectiveness and experiences of creativity workshops for young adults with anxiety and depression: protocol for Trial Within a Cohort Study as part of the research programme: ‘Building resilience and resources to reduce depression and anxiety in young people from urban neighborhoods in Latin America (OLA)’ |
| Study objectives | The specific research questions are: 1. How effective are creativity workshops in reducing symptoms of anxiety and/or depression in young adults? 2. How feasible are creativity workshops as an intervention for young adults with anxiety and/or depression? 3. How are creativity workshops experienced by young adult participants? |
| Ethics approval(s) | 1. Approved 05/05/2022, Institutional Research and Ethics Committee of the Universidad Peruana Cayetano Heredia(Av. Honorio Delgado 430, San Martín de Porres, Apartado postal 4314, Lima, Peru; +51 (0)319 0000 Anexo 201302; duict.cieh@oficinas-upch.pe), ref: CONSTANCIA 187-18-22 2. Approved 24/08/2022, Ethics Committee of the School of Medicine of the Universidad de Buenos Aires, Buenos Aires, Argentina (Paraguay 2155 - 1º Piso M1- Decanato - Secretaría de Ciencia y Técnica, C1121A6B - Ciudad A. de Bs As; +54 (11) 528-52954 / 52955; comitedeetica@fmed.uba.ar) |
| Health condition(s) or problem(s) studied | Young adults with symptoms of depression and anxiety |
| Intervention | A 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 young adult cohort in Buenos Aires and Lima 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 creativity workshop (intervention group). A researcher from the QMUL team, but not involved in the TWIC or OLA project, will perform the randomization. There will be a total of four workshops across the two sites: two in Buenos Aires and two in Lima, with 15 participants in each workshop. The creativity workshops will follow a programme developed, practiced and led by Crear Vale La Pena (Buenos Aires) and Teatro La Plaza (Lima). They will draw from different artistic disciplines and methodologies such as theatre, poetry, movement, visual arts and music to explore the concerns of young people at times of transition and the learnings from it. Each workshop will include a total of three in-person sessions, each lasting approximately 2-3 hours with a break. |
| Intervention type | Other |
| Primary outcome measure | Self-rated depression/anxiety symptoms measured using the Patient Health Questionnaire (PHQ-8) and the Generalised Anxiety Disorder Assessment (GAD-7) questionnaire at the 12-month follow-up rating in the cohort study, adjusted for the 6-months follow-up scores in the cohort study, of both the intervention and control group, supplemented with pre-post intervention changes (PHQ-8 and GAD-7 scores before and after the 3-week intervention) |
| Secondary outcome measures | 1. Feasibility assessed by acceptance of workshop participation and attendance of workshop sessions at the end of the 3-session workshop 2. Experiences assessed by exit questionnaire responses expressed after the end of the intervention |
| Overall study start date | 01/12/2021 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 24 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Young adults (20-24 years old when recruited for the cohort) who have symptoms of anxiety and/or depression at baseline and 6-month follow-up 2. Capacity to provide informed consent (intervention group only) |
| Key exclusion criteria | 1. Participants who at present already regularly attend organised creative (e.g. theatre, circus, dancing, drama) activities (based on baseline assessment) 2. Participants who expressed no interest in participating in any arts activities (based on baseline assessment) |
| Date of first enrolment | 11/05/2022 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Argentina
- Peru
Study participating centres
Buenos Aires
C1121ABG
Argentina
Lima
15102
Peru
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
Research council
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 limited to) young adults and adolescents, 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 PI (Stefan Priebe: stefan.priebe2@nhs.net) and the local PIs (Luis Brusco: lbrusco@fmed.uba.ar, and Francisco Diez Canseco, fdiezcanseco@upch.pe) 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 PI (Stefan Priebe: stefan.priebe2@nhs.net) and the local PIs (Luis Brusco: lbrusco@fmed.uba.ar, and Francisco Diez Canseco: fdiezcanseco@upch.pe) 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 creative 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 PI (Priebe) will be the custodian of the data. The data collected in Peru will also be stored at the main study site in Universidad Peruana Cayetano Heredia, and Francisco Diez Canseco will be custodian of these data. The data collected in Argentina will also be stored at the main study site in Universidad de Buenos Aires, and Luis Brusco will be custodian of these data. This will be done according to the regulation for data storage and protection at Universidad Peruana Cayetano Heredia and Universidad de Buenos Aires, respectively. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 12/04/2022 | 06/06/2022 | No | No |
Additional files
Editorial Notes
11/11/2024: Study website and total final enrolment added.
27/09/2024: Internal review.
17/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 30/09/2022.
2. The overall end date was changed from 29/02/2024 to 31/10/2023.
3. The plain English summary was updated to reflect these changes.
30/09/2022: Ethics approval details added.
06/06/2022: Trial's existence confirmed by the Institutional Research and Ethics Committee of the Universidad Peruana Cayetano Heredia.
