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

Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle income countries in south eastern Europe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11913964
Enrollment
480
Registered
2019-03-29
Start date
2019-02-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis Mental and Behavioural Disorders

Interventions

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 rec

Sponsors

European Commission, Directorate-General for Research and Innovation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
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)

Primary

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

Countries

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

Contacts

Public ContactTamara Pemovska
t.pemovska@qmul.ac.uk+44 (0)20 7540 4380 x 2330

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026