Condition category
Mental and Behavioural Disorders
Date applied
09/11/2018
Date assigned
20/11/2018
Last edited
20/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
DIALOG+ is an intervention delivered on a tablet or smartphone 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 lives (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 patients, using four steps that focus 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 Colombia. 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?
Patients aged 18-65 with severe mental illness (psychosis, bipolar disorder and/or severe depression)

What does the study involve?
All patients are randomly allocated into two groups. Patients in the DIALOG+ group use the app with their clinicians once per month for a period of 6 months. The other group (the control) do not use DIALOG+ (both groups receive their usual treatment). The two groups of patients are compared to see if DIALOG+ makes a difference to outcomes like quality of life and symptoms. Patients in the DIALOG+ group are also interviewed to see how they experienced the intervention.

What are the possible benefits and risks of participating?
For patients, they will be taking part in testing an intervention which might lead to improved quality of life, social functioning and symptoms. The study will also benefit clinicians who take part in terms of the training and supervision they will receive to enable them to implement the intervention. For all participants involved in the research, their suggestions and experiences might be incorporated into further adaptations of DIALOG+, so that it is tailored to the needs of patients, carers and clinicians in the context of the mental health care system in Colombia. Severe mental illnesses cause a high burden for societies with high levels of distress and high costs to individuals who are affected. This is particularly worse in low and middle-income countries such as Colombia, where there is a lack of human and financial resources for specialised mental health services in the community. In recent years, the Ministry of Health in Colombia has been developing a new model of care to improve care for people with severe mental illness in the community. The testing of DIALOG+ will therefore contribute to this work by providing evidence for interventions for people with severe mental illness in the community. It is unlikely that any significant ethical, legal or management issues will arise from this study, but some potential risks might be: within the research assessments and interviews that will take place across both studies, questions will be raised with participants that might trigger feelings of distress or anxiety. Participants may experience anxiety in trying a new intervention. Throughout the intervention-testing period, individuals will continue to receive their routine care, including any medication, in addition to the test intervention. The intervention can be stopped at any point. The intervention (DIALOG+) to be tested has an evidence base for effectiveness.

Where is the study run from?
1. San Ignacio University Hospital (Columbia)
2. Clinica La Inmaculada (Columbia)
3. Clinica Fray Bartolome (Columbia)
4. Hospital Departamental Psiquiátrico Universitario del Valle ESE (Columbia)

When is the study starting and how long is it expected to run for?
August 2017 to July 2018

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Ms Sana Sajun
2. Ms Catherine Fung

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

Type

Scientific

Additional contact

Ms Catherine Fung

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/137/97

Study information

Scientific title

Testing the effectiveness, acceptability and feasibility of DIALOG+ in severe mental illness in Colombia: a randomised controlled trial

Acronym

Study hypothesis

To test the acceptability, feasibility and effectiveness of DIALOG+ against usual treatment.
The specific research questions are :
1. How can DIALOG+ be used to support community mental health care in Colombia?
2. How is DIALOG+ experienced by patients and professionals?
3. How do patient outcomes change when DIALOG+ is used?

Ethics approval

1. IRB of Javeriana University, 19/09/2018, ref: 2018/122
2. Ethics Committee of the University Hospital of Valle, 08/10/2018
3. Ethics Committee of Clínica La Inmaculada,16/07/2018
4. Ethics Committee of Clínica Fray Bartolomé: approval pending
5. Queen Mary Ethics of Research Committee (QMERC2018/59): positive opinion received 30/10/2018

Study design

Interventional multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

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

Recruitment will take place at University Hospital of Valle, Clínica La Inmaculada, Clínica Fray Bartolomé and San Ignacio Hospital.
14 clinicians will be recruited. For each clinician, the research team will recruit 12 of their patients and then each clinician-patient cluster will be randomly allocated to a control or intervention group. Randomisation will be done by the UK-based research team using STATA statistical softwareand allocations and communicated to the unmasked researchers in the Colombia team. Clinician-patient clusters (12 patients per clinician) will be randomised to either the intervention or control groups so that each clinicians will be either delivering DIALOG+ OR delivering usual treatment to their patients.

Masking: randomisation will take place after recruitment of participants and completion of baseline assessments. Follow-up assessments at 6 and 12 months will be completed with participants by masked researchers. Measures are in-place to ensure that researchers completing follow-up research assessments remain masked to participant allocation and to minimise risk of contamination in clinicians allocated to the control group.

Patients allocated to the intervention group will receive DIALOG+ at their routine outpatient clinic 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+ aims to make routine meetings between clinicians and patients therapeutically effective.

Patients allocated to the control group will complete the DIALOG scale at their routine outpatient clinic appointments once per month over the 6 month period.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Quality of life, measured using the Manchester Short Assessment of Quality of Life (MANSA) measured at baseline, 6 months (post intervention) and 12 months

Secondary outcome measures

Measured at baseline, 6 months (post intervention) and 12 months:
1. Objective social functioning, measured with the objective social outcome index (SIX)
2. Symptoms, measured with the Brief Psychiatric Rating Scale (BPRS)
3. Service use, measured with adapted Client Service Receipt Inventory (CSRI)

Overall trial start date

01/08/2017

Overall trial end date

31/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary diagnosis of severe mental illness (psychosis, bipolar disorder and/or severe depression) ICD F20-29, F31, F32
2. Aged 18-65 years old
3. Attending clinic for at least 6 months
4. Scores 5 or below on the MANSA scale
5. Capacity to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

168 patients (14 clinicians)

Participant exclusion criteria

1. Does not meet inclusion criteria
2. Primary diagnosis of substance-use disorder
3. Diagnosis of dementia or organic psychosis
4. An inpatient at the time of recruitment
5. Participating in another study being conducted by this or another research group

Recruitment start date

19/11/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

Colombia

Trial participating centre

San Ignacio University Hospital
Cra. 7 #40-62
Bogota
N/A
Colombia

Trial participating centre

Clinica La Inmaculada
Cra. 7 #6970
Bogota
N/A
Colombia

Trial participating centre

Clinica Fray Bartolome
Cra. 65 #66
Bogota
N/A
Colombia

Trial participating centre

Hospital Departamental Psiquiátrico Universitario del Valle ESE
Calle 5 No. 80-00, Santiago de Cali
Cali
N/A
Colombia

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Blizard Building
4 Newark St
Whitechapel
London
E1 2AT
United Kingdom

Sponsor type

University/education

Website

https://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The statistical analysis plan is being written and the trialists are planning publication(s) of a large protocol paper describing the work of their Research Group, including this study, and are considering writing more detailed protocol papers. The trialists intend to publish the quantitative and qualitative findings from this study by August 2020.
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 trialists plan to disseminate findings across Colombia and across two wider networks, LatinCLEN and Red Maristan, that supports research and teaching of young mental health researchers across the region. Dissemination will include publications, attending conferences, and using platforms like Twitter and the Group website.

IPD sharing statement
The trialists will ensure that the study dataset is available for sharing on request following the publication of the main research papers. This is to ensure the scientific impact of the project is maximised. Prior to making the dataset available to interested individuals, the dataset will be pseudonymised and any potentially identifiable data removed. For publications that require data to be accessible, the trialists will comply with this as guided by FAIR principles.

Intention to publish date

31/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes