Psycho-social treatment for people with psychosis in south eastern Europe
| ISRCTN | ISRCTN11913964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11913964 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 779334 |
| Sponsor | European Commission, Directorate-General for Research and Innovation |
| Funder | European Commission |
- Submission date
- 21/03/2019
- Registration date
- 29/03/2019
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People with psychosis sometimes hear voices, and don’t understand what is real and what is not, for example, they can think that family or friends are part of a conspiracy to harm them. They can also experience low mood, isolation and lack of hope and initiative. People with psychosis die 15-20 years earlier than other citizens due to under diagnosed physical illnesses, poor access to healthcare and suicide. In countries with low income up to 50% of people with psychosis do not receive care for their condition. Available treatment is largely focused on anti-psychotic medication which neglects people’s social needs and resources. The aim of this study is to test a psycho-social treatment for people with psychosis in south eastern Europe.
Who can participate?
Patients aged 18 or older with psychosis
What does the study involve?
Participants are allocated by chance to either an intervention called Dialog+ or treatment as usual for 12 months. Dialog+ is used during routine clinical meetings. The clinician asks the patient to talk about their satisfaction with different areas of life, such as mental health, physical health, medication, family life, etc. In this way the patient identifies problems and in the next step the patient is guided by the clinician to identify solutions to these problems. Clinicians and patients use computer tablets to engage in this conversation. It is expected that Dialog+ will improve the quality of life and mental health of patients with psychosis.
What are the possible benefits and risks of participating?
Possible benefits for patients include feeling less distressed and having better quality of life. No risks of participating have been reported. However, some participants might become upset due to recalling distressing personal experiences. Appropriate support will be provided to distressed individuals.
Where is the study run from?
1. Universiteti i Prishtines (Kosovo)
2. Klinicki Centar Univerziteta U Sarajevu (Bosnia and Herzegovina)
3. Faculty of Medicine, University of Belgrade (Serbia)
4. University Clinic of Psychiatry Skopje (Macedonia)
5. Clinical Centre of Montenegro (Montenegro)
When is the study starting and how long is it expected to run for?
April 2019 to June 2020
Who is funding the study?
European Commission
Who is the main contact?
1. Tamara Pemovska
t.pemovska@qmul.ac.uk
2. Dr Nikolina Jovanovic
n.jovanovic@qmul.ac.uk
Contact information
Public
Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom
| Phone | +44 (0)20 7540 4380 x 2330 |
|---|---|
| t.pemovska@qmul.ac.uk |
Scientific
Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0002-7554-9837 |
|---|---|
| Phone | +44 (0)20 7540 4380 |
| n.jovanovic@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Hybrid type 2 effectiveness/implementation, multi-centre study; effectiveness will be studied in a pragmatic, parallel-group, cluster-randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Scientific title | Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle income countries in south eastern Europe |
| Study acronym | IMPULSE |
| Study objectives | The intervention (Dialog+) is effective in reducing clinical symptoms, improving quality of life and in reducing treatment costs for people with psychosis. |
| Ethics approval(s) | Approved 16/10/2018, Queen Mary Ethics of Research Committee (Queen Mary, University of London, Room W117, Queen’s Building, Mile End Road, London E1 4NS; Tel: +44 (0)20 7882 7915; Email: h.covill@qmul.ac.uk), ref: QMREC2204a The study has been approved by institutional ethics committees in all participating countries: Bosnia and Herzegovina (Klinicki Centar Univerziteta U Sarajevu), Former Yugoslav Republic of Macedonia (University Clinic Of Psychiatry, Skopje), Kosovo (Universiteti I Prishtines), Montenegro (Clinical Centre Of Montenegro, Podgorica), and Serbia (Klinicki Centar Univerziteta U Beogradu). |
| Health condition(s) or problem(s) studied | Psychosis |
| Intervention | After baseline assessments, clinicians will be randomized to the intervention (DIALOG+ for 12 months) or control (TAU for 12 months), with an allocation ratio of 1:1. The intervention group will receive DIALOG+, an evidence-based, technology-assisted intervention designed to make routine meetings between clinicians and patients patient-centred, structured and more therapeutically effective. The control group will include routine meetings offering treatment as usual. This includes consultations on medication, psychological support and discussion on other aspects of care. After 12 months, clinicians in the control groups will be trained to deliver DIALOG+ and the intervention will be offered to patients in the control group. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Subjective quality of life measured by Manchester Short Assessment of Quality of Life (MANSA) at baseline, 6 months and 12 months |
| Key secondary outcome measure(s) |
Measured at baseline, 6 months and 12 months: |
| Completion date | 26/06/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 480 |
| Total final enrolment | 549 |
| Key inclusion criteria | Clinicians: 1. Having a professional qualification in mental health care 2. More than 6 months’ experience of working in mental health care 3. No plans to leave their post within the study period Patients: 1. Primary diagnosis of psychosis or related disorder (i.e.: ICD-10 F20-29, F31) 2. Aged 18 years or older 3. Attending the outpatient clinic or day hospital 4. History of at least one hospital admission in their lifetime 5. There should not be plans to be discharged from mental health care services for the next 12 months 6. Capacity to provide informed consent |
| Key exclusion criteria | Clinicians: 1. No exclusion criteria Patients: 1. Having a diagnosis of organic brain disorders 2. Having severe cognitive deficits (unable to provide information to study instruments). This will be based on the clinical judgement |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 01/09/2019 |
Locations
Countries of recruitment
- Bosnia and Herzegovina
- Kosovo
- Montenegro
- North Macedonia
- Serbia
Study participating centres
Prishtina
10000
Kosovo
Sarajevo
71000
Bosnia and Herzegovina
Belgrade
11000
Serbia
Skopje
10000
North Macedonia
Podgorica
81000
Montenegro
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Anonymised dataset will be available on request from April 2021. Requests can be sent to Dr Nikolina Jovanovic, (n.jovanovic@qmul.ac.uk). The researchers will not share analysed data as they want to have them published in an open access peer reviewed journal. All patients and clinicians participating in the study signed informed consent approved by the relevant ethics committees. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/01/2020 | 20/09/2021 | Yes | No | |
| Basic results | 21/01/2022 | 21/01/2022 | No | No | |
| Interim results article | Physical health of individuals with psychosis - a mixed method study | 16/01/2023 | 17/01/2023 | Yes | No |
| Other publications | Economic evaluation | 26/08/2022 | 08/04/2024 | Yes | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN11913964_BasicResults_21Jan2022.pdf
- Basic results
Editorial Notes
08/04/2024: Publication reference added.
17/01/2023: Publication reference added.
21/01/2022: The basic results of this trial have been uploaded as an additional file.
20/09/2021: Publication reference added.
18/01/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/01/2021 to 26/06/2020 and the plain English summary updated accordingly.
2. The final enrolment number has been added.
19/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2019 to 01/09/2019.
2. The overall trial end date was changed from 01/04/2020 to 01/01/2021.
3. The intention to publish date was changed from 31/12/2020 to 01/01/2022.
27/03/2019: Trial's existence confirmed by ethics committees.
