Condition category
Mental and Behavioural Disorders
Date applied
21/03/2019
Date assigned
29/03/2019
Last edited
28/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 April 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

Trial website

http://impulse.qmul.ac.uk/home/

Contact information

Type

Public

Primary contact

Miss Tamara Pemovska

ORCID ID

Contact details

Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom
+44 (0)20 7540 4380 x 2330
t.pemovska@qmul.ac.uk

Type

Scientific

Additional contact

Dr Nikolina Jovanovic

ORCID ID

http://orcid.org/0000-0002-7554-9837

Contact details

Queen Mary University of London
NCfMH
Academic Unit
Glen Road
London
E13 8SP
United Kingdom
+44 (0)20 7540 4380
n.jovanovic@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

779334

Study information

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

Acronym

IMPULSE

Study hypothesis

The intervention (Dialog+) is effective in reducing clinical symptoms, improving quality of life and in reducing treatment costs for people with psychosis.

Ethics approval

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).

Study design

Hybrid type 2 effectiveness/implementation, multi-centre study; effectiveness will be studied in a pragmatic, parallel-group, cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Subjective quality of life measured by Manchester Short Assessment of Quality of Life (MANSA) at baseline, 6 months and 12 months

Secondary outcome measures

Measured 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 trial start date

01/04/2019

Overall trial end date

01/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

80 clinicians and 400 patients

Participant 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

Recruitment start date

01/02/2019

Recruitment end date

01/04/2019

Locations

Countries of recruitment

Bosnia and Herzegovina, Kosovo, Macedonia, Montenegro, Serbia

Trial participating centre

Universiteti i Prishtines
Street Nena Tereze
Prishtina
10000
Kosovo

Trial participating centre

Klinicki Centar Univerziteta U Sarajevu
Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina

Trial participating centre

Faculty of Medicine, University of Belgrade
Dr Subotica, 8
Belgrade
11000
Serbia

Trial participating centre

University Clinic of Psychiatry Skopje
Belgradska b.b.
Skopje
10000
Macedonia

Trial participating centre

Clinical Centre of Montenegro
Ljubljanska bb
Podgorica
81000
Montenegro

Sponsor information

Organisation

European Commission, Directorate-General for Research and Innovation

Sponsor details

Rue du Champ de Mars 21
Brussels
1049
Belgium
+32 (0)229-67693
sara.BRAZYS@ec.europa.eu

Sponsor type

Research council

Website

http://ec.europa.eu/research/health/

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

European Union, EC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

The 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 statement
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.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/03/2019: Trial's existence confirmed by ethics committees.