Psycho-social treatment for people with psychosis in south eastern Europe

ISRCTN ISRCTN11913964
DOI https://doi.org/10.1186/ISRCTN11913964
Secondary identifying numbers 779334
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Miss Tamara Pemovska
Public

Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom

Phone +44 (0)20 7540 4380 x 2330
Email t.pemovska@qmul.ac.uk
Dr Nikolina Jovanovic
Scientific

Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom

ORCiD logoORCID ID 0000-0002-7554-9837
Phone +44 (0)20 7540 4380
Email n.jovanovic@qmul.ac.uk

Study information

Study designHybrid type 2 effectiveness/implementation, multi-centre study; effectiveness will be studied in a pragmatic, parallel-group, cluster-randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleImplementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle income countries in south eastern Europe
Study acronymIMPULSE
Study objectivesThe 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) studiedPsychosis
InterventionAfter 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 typeMixed
Primary outcome measureSubjective quality of life measured by Manchester Short Assessment of Quality of Life (MANSA) at baseline, 6 months and 12 months
Secondary outcome measuresMeasured at baseline, 6 months and 12 months:
1. Treatment satisfaction measured using Client Satisfaction Questionnaire (CSQ)-8
2. Clinical symptoms measured using Brief Symptom Inventory (BSI), Brief Psychiatric Rating Scale (BPRS), and Clinical Assessment Interview for Negative Symptoms (CAINS)
Overall study start date01/04/2019
Completion date26/06/2020

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80 clinicians and 400 patients. Final: 81 clinicians and 468 patients
Total final enrolment549
Key inclusion criteriaClinicians:
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 criteriaClinicians:
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 enrolment01/02/2019
Date of final enrolment01/09/2019

Locations

Countries of recruitment

  • Bosnia and Herzegovina
  • Kosovo
  • Montenegro
  • North Macedonia
  • Serbia

Study participating centres

Universiteti i Prishtines
Street Nena Tereze
Prishtina
10000
Kosovo
Klinicki Centar Univerziteta U Sarajevu
Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina
Faculty of Medicine, University of Belgrade
Dr Subotica, 8
Belgrade
11000
Serbia
University Clinic of Psychiatry Skopje
Belgradska b.b.
Skopje
10000
North Macedonia
Clinical Centre of Montenegro
Ljubljanska bb
Podgorica
81000
Montenegro

Sponsor information

European Commission, Directorate-General for Research and Innovation
Research council

Rue du Champ de Mars 21
Brussels
1049
Belgium

Phone +32 (0)229-67693
Email sara.BRAZYS@ec.europa.eu
Website http://ec.europa.eu/research/health/
ROR logo "ROR" https://ror.org/01ef4as46

Funders

Funder type

Government

European Commission
Government organisation / National government
Alternative name(s)
European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

Results and Publications

Intention to publish date01/01/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe researchers plan to publish the study protocol. Publication of the study results in a high-impact peer reviewed journal can be expected at the end of 2020. Study findings will be disseminated through a variety of mediums, including national and international meetings with clinicians, policy-makers and researchers, national workshops, end-of-study workshops, peer-reviewed journal articles, Twitter posts and updates on the project’s own website (http://impulse.qmul.ac.uk/home/).
IPD sharing planAnonymised 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

Additional files

ISRCTN11913964_BasicResults_21Jan2022.pdf

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.