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 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 2021 (updated 09/06/2020, previously: December 2020)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Sana Sajun
s.sajun@qmul.ac.uk
2. Ms Erin Burn
e.burn@qmul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Sana Sajun
ORCID ID
Contact details
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
s.sajun@qmul.ac.uk
Type
Scientific
Additional contact
Ms Erin Burn
ORCID ID
Contact details
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2344
e.burn@qmul.ac.uk
Type
Scientific
Additional contact
Dr Francois van Loggerenberg
ORCID ID
Contact details
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
f.vanloggerenberg@qmul.ac.uk
Type
Scientific
Additional contact
Dr Michael McGrath
ORCID ID
Contact details
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
m.mcgrath@qmul.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
16/137/97
Study information
Scientific title
Testing the effectiveness, acceptability and feasibility of DIALOG+ in severe mental illness in
Argentina: a non-controlled trial
Acronym
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
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
Study design
Interventional single-centre non-controlled study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Patients with severe mental illness (including psychosis, bipolar disorder and severe depression)
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
Phase
Drug names
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 trial start date
01/12/2019
Overall trial end date
31/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients (5 healthcare providers)
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
15/12/2019
Recruitment end date
30/11/2020
Locations
Countries of recruitment
Argentina
Trial participating centre
Fundación Humanas
Santos Dumont 3454
Buenos Aires
C1427EIB
Argentina
Trial participating centre
Las Heras
Av. Las Heras 2492
Buenos Aires
C1425ASS
Argentina
Trial participating centre
Centre of Neuropsychiatry and Neurology of Behavior (CENECON)
Paraguay 2155
Buenos Aires
C1121ABG
Argentina
Sponsor information
Organisation
Queen Mary University of London
Sponsor details
4 Newark St
Whitechapel
London
E1 2AT
United Kingdom
+44 (0)20 7540 4380 ext: 2312
s.sajun@qmul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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 statement
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.
Intention to publish date
31/07/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN38851969_PROTOCOL_V1.0_18Jun19.docx Uploaded 10/01/2020