A research study in Bosnia and Herzegovina to test a Family Involvement intervention, designed to improve care for people living in the community with severe mental illness

Testing the effectiveness, acceptability and feasibility of Family Involvement in severe mental illness in Bosnia and Herzegovina: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13347355

Enrollment

Registered

2018-11-20

Start date

2018-12-01

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Patients with severe mental illness (including psychosis) Mental and Behavioural Disorders

Interventions

72 patients will be recruited. Each patient will be randomly allocated to either a control or intervention group. Randomisation will be done by UK based research team using STATA statistical software

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a primary diagnosis of severe mental illness (ICD-10 F2) 2. Aged 18 years and older 3. Capacity to provide informed consent 4. Scores 5 or below on the MANSA scale 5. Illness of over 6 months

Exclusion criteria

Exclusion criteria: 1. Does not meet inclusion criteria 2. Primary diagnosis of substance-use disorder, learning disability, dementia, organic psychosis 3. Diagnosis of bipolar disorder 4. Participating in another study conducted by this or another research group

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Objective social functioning, measured using Objective social outcome index (SIX) at baseline, 6 and 12 months 2. Symptoms, measured using Brief Psychiatric Rating Scale (BPRS) at baseline, 6 and 12 months 3. Service use, measured using adapted Client Service Receipt Inventory (CSRI) at baseline, 6 and 12 months 4. Client satisfaction, measured using Client Satisfaction Questionnaire (CSQ-8) at 6 and 12 months 5. Self esteem, measured using Self-esteem rating scale at baseline, 6 and 12 months 6. Insight and Treatment Attitudes, measured using ITAQ at baseline, 6 and 12 months	—

Measure

Time frame

1. Objective social functioning, measured using Objective social outcome index (SIX) at baseline, 6 and 12 months 2. Symptoms, measured using Brief Psychiatric Rating Scale (BPRS) at baseline, 6 and 12 months 3. Service use, measured using adapted Client Service Receipt Inventory (CSRI) at baseline, 6 and 12 months 4. Client satisfaction, measured using Client Satisfaction Questionnaire (CSQ-8) at 6 and 12 months 5. Self esteem, measured using Self-esteem rating scale at baseline, 6 and 12 months 6. Insight and Treatment Attitudes, measured using ITAQ at baseline, 6 and 12 months

—

Countries

Bosnia and Herzegovina

Contacts

Public ContactFrancois van Loggerenberg

f.vanloggerenberg@qmul.ac.uk+44 (0)20 7540 4380 Ext: 2339

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026