A research study in Argentina to test an intervention called DIALOG+ designed to improve care for people living in the community with severe mental illness
| ISRCTN | ISRCTN38851969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38851969 |
| Secondary identifying numbers | 16/137/97 |
- Submission date
- 05/12/2019
- Registration date
- 16/12/2019
- Last edited
- 06/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
DIALOG+ is an intervention delivered on a tablet using an App. It is designed to help mental health professionals to improve the structure of their routine meetings with patients. It also helps to improve communication with patients during these meetings. Patients are first asked about how satisfied they are with eight areas of their life (e.g. physical health, family relationships, leisure activities) and three areas of the treatment they are receiving (e.g. practical help, meetings) which is called the DIALOG scale. The patient then chooses up to three areas to discuss in more depth with their health professional. The clinician then discusses each area chosen by the patient, using a four-step approach that focuses on solutions to the identified problems. This study aims to find out whether DIALOG+ can help to improve care for people living with severe mental illness in Argentina. More specifically, the researchers want to find out how patients and health professionals experience DIALOG+ when it is used during their routine meetings. They also want to find out if DIALOG+ improves outcomes like quality of life and symptoms.
Who can participate?
Any patient receiving care at one of the study sites who has a primary diagnosis of severe mental illness (specifically an anxiety disorder) and who is aged 18-65
What does the study involve?
Patients use the DIALOG+ App within their routine clinical appointments once per month for a period of 6 months. This is delivered by their usual clinician using an app on a tablet computer. The intervention is over 6 months during which patients receive 6-7 DIALOG+ sessions. The researchers also interview patients and clinicians who have used DIALOG+ to see how they experienced the intervention.
What are the possible benefits and risks of participating?
Severe mental illnesses cause high levels of distress to affected individuals. In countries such as Argentina 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 Argentina. Additionally, for patients who will be involved in testing the intervention, this might lead to improved quality of life and symptom reduction. Mental health professionals will also benefit in terms of the training and supervision they will receive to enable them to implement the intervention.
The researchers do not predict any significant risks from participating in this study; however, it is possible that whilst completing the research assessment or qualitative interviews, the questions asked might trigger feelings of distress or anxiety. To minimise this risk, researchers with experience working with people with severe mental illness were employed. Additionally, research assessments can be stopped at any point, and further support can be provided to the participant if necessary. Participants might also experience anxiety in trying new interventions. Through the intervention-testing period, individuals will continue to receive their routine care, including any medication. The intervention can be stopped at any point.
Where is the study run from?
1. Fundación Humanas (Argentina)
2. Las Heras (Argentina)
3. Centre of Neuropsychiatry and Neurology of Behavior (CENECON) (Argentina)
When is the study starting and how long is it expected to run for?
December 2019 to March 2022 (updated 20/09/2021, previously: December 2021 (updated 12/07/2021, previously: July 2021; updated 08/03/2021, previously: March 2021))
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Francois van Loggerenberg, f.vanloggerenberg@qmul.ac.uk
Contact information
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)20 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
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)20 540 4380 Ext: 2339 |
| f.vanloggerenberg@qmul.ac.uk |
Study information
| Study design | Interventional single-centre non-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| 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 DIALOG+ in severe mental illness in Argentina: a non-controlled trial |
| Study hypothesis | To test the acceptability, feasibility and effectiveness of DIALOG+. The specific research questions are: 1. How can DIALOG+ be used to support community mental health care in Argentina? 2. How is DIALOG+ experienced by patients and professionals? 3. How do patient outcomes change when DIALOG+ is used? |
| Ethics approval(s) | 1. Approved 08/10/2019, Universidad Buenos Aires Ethics Committee (Prof. Marín Rafael Seoana, Marcelo T. de Alvear 2270, Buenos Aires, Argentina; Tel: +54 (0)11 5285-2751; Email: sectaquini@fmed.uba.ar) 2. Approved 21/11/2019, 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; Tel: +44 (0)20 7882 7915; Email: h.covill@qmul.ac.uk), ref: QMERC2019/78 |
| Condition | Patients with severe mental illness (specifically anxiety disorders) |
| Intervention | At least 5 clinicians and 40 patients will be recruited. Patients will receive DIALOG+ at their routine clinical appointments once per month. This will be delivered by their usual clinician using an app on a tablet computer. The intervention will be over 6 months during which patients will receive 6-7 DIALOG+ sessions. DIALOG+ is a technology-mediated intervention, which involves a structured patient assessment covering satisfaction with eight life domains and three treatment domains (DIALOG scale) and a four-step solution-focused therapy approach to address patient concerns (DIALOG+). DIALOG+ aims to make routine meetings between clinicians and patients therapeutically effective. |
| Intervention type | Behavioural |
| Primary outcome measure | Quality of life measured using the Manchester Short Assessment of Quality of Life (MANSA) measured at baseline and 6 months |
| Secondary outcome measures | 1. Objective social functioning measured using the Objective Social Outcome Index (SIX) at baseline and 6 months 2. Symptoms measured using the Brief Psychiatric Rating Scale (BPRS) at baseline and 6 months 3. Service use measured using adapted Client Service Receipt Inventory (CSRI) at baseline and 6 months 4. Patients' experience of the DIALOG+ intervention assessed using qualitative interviews at 6 months |
| Overall study start date | 01/12/2019 |
| Overall study end date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 patients (5 healthcare providers) |
| Participant inclusion criteria | Current inclusion criteria as of 18/12/2020: 1. Primary diagnosis of an anxiety disorder 2. Aged 18-65 years old 3. Capacity to provide informed consent 4. Score of 5 or below on the MANSA scale 5. Receiving care from a participating health care provider Previous inclusion criteria: 1. Primary diagnosis of severe mental illness as defined by ICD10: F20-9, F31, F32 2. Aged 18-65 years old 3. Capacity to provide informed consent 4. Score of 5 or below on the MANSA scale 5. Receiving care from a participating health care provider |
| Participant exclusion criteria | 1. Diagnosis of dementia or organic psychosis as determined by their health providers 2. Primary diagnosis of substance use disorder 3. Severe learning difficulties or severe cognitive disability |
| Recruitment start date | 22/05/2021 |
| Recruitment end date | 01/08/2021 |
Locations
Countries of recruitment
- Argentina
Study participating centres
Buenos Aires
C1427EIB
Argentina
Buenos Aires
C1425ASS
Argentina
Buenos Aires
C1121ABG
Argentina
Sponsor information
University/education
4 Newark St
Whitechapel
London
E1 2AT
England
United Kingdom
| Phone | +44 (0)20 7540 4380 ext: 2312 |
|---|---|
| s.sajun@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk |
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 | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to publish the quantitative and qualitative findings from this study by March 2021. 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. The researchers plan to disseminate findings across Argentina. Dissemination will include publications, attending conferences, and using platforms like Twitter and the group website. |
| IPD sharing plan | The datasets 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 between the research group using an online data collection platform called REDCap. 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 enrollment and all subsequent data collected will be linked to this ID, without any link to identifiable data following Good Clinical Practice. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1.0 | 18/06/2019 | 10/01/2020 | No | No |
Additional files
- ISRCTN38851969_PROTOCOL_V1.0_18Jun19.docx
- Uploaded 10/01/2020
Editorial Notes
06/12/2022: A contact was removed.
04/10/2021: The public and scientific contacts have been changed and the plain English summary updated accordingly.
20/09/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 01/03/2022.
2. The recruitment end date was changed from 01/09/2021 to 01/08/2021.
3. The plain English summary was updated to reflect these changes.
21/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 15/12/2019 to 22/05/2021.
2. The recruitment end date has been changed from 30/09/2021 to 01/09/2021.
12/07/2021: Recruitment for this study is no longer paused as of 22/05/2021 and the following changes have been made:
1. The recruitment end date has been changed from 30/11/2020 to 30/09/2021.
2. The overall end date was changed from 31/07/2021 to 31/12/2021
08/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2021 to 31/07/2021.
2. The intention to publish date was changed from 31/07/2021 to 31/07/2022.
3. The plain English summary was updated to reflect these changes.
18/12/2020: The following changes were made to the trial record:
1. The condition field was changed from 'Patients with severe mental illness (including psychosis, bipolar disorder and severe depression)' to 'Patients with severe mental illness (specifically anxiety disorders)'.
2. The inclusion criteria and plain English summary were updated accordingly.
11/08/2020: Two scientific contacts have been added.
09/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2020 to 30/11/2020.
2. The overall end date was changed from 31/12/2020 to 31/03/2021.
3. The intention to publish date was changed from 31/03/2021 to 31/07/2021.
4. The plain English summary was updated to reflect these changes.
03/04/2020: Due to current public health guidance, recruitment for this study has been paused. The recruitment end date has been changed from 15/03/2020 to 31/05/2020.
10/01/2020: Uploaded protocol Version 1.0, 18 June 2019 (not peer reviewed).
16/12/2019: Internal review.
06/12/2019: Trial's existence confirmed by Queen Mary Ethics of Research Committee.
