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Feasibility study of an international framework to evaluate the impact of Open Dialogue

HOPEnDialogue Feasibility Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13106513
Enrollment
90
Registered
2026-08-10
Start date
2022-05-11
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Severe and/or enduring mental illness Mental and Behavioural Disorders

Interventions

This is a Exploratory feasibility design - Cohort study. The study is an international naturalistic observational cohort study of consecutive patients with psychotic and other severe mental health dif

Sponsors

Institute of Cognitive Sciences and Technologies
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patient 1. Experiencing psychotic or any other severe mental illness such as major depression, personality disorders, bipolar disorder, etc., requiring mental health support OR 2. Evidence of a mental health crisis indicated by: 2.1. A rating of A-C on the UK Mental Health Triage Scale (Sands et al., 2016), which indicates either an emergency, very urgent or urgent response is needed based on a high risk of harm self or others and/or rapidly increasing symptoms of psychosis or severe mood disorder 2.2. An admission to an inpatient ward, or 2.3. Being accepted into the care of a mental health crisis service AND 3. Between 18 and 65 years of age AND 4. Sufficient abilities in the official language of the country where the pilot site is located Carers 1. Being a family member or a caregiver of one of the patients enrolled in the study

Exclusion criteria

Exclusion criteria: 1. A primary diagnosis of substance misuse 2. A diagnosis of dementia or an acquired cognitive impairment 3. A primary diagnosis of a learning disability 4. Current forensic involvement 5. Already received OD in the past 6. Participation in another research project that may impact the patient care in the HOPEnDialogue study 7. Risk of harm to the participant, study clinicians, or researchers

Design outcomes

Primary

MeasureTime frame
Global Assessment of Functioning (GAF) scale data completeness measured using proportion of required records with a valid GAF score recorded at end of study (12 months);Retention rate measured using the percentage of participants who complete the 12-month follow-up questionnaires at end of study (12 months);Attrition rate measured using the percentage of participants who did not complete the 12-month follow-up questionnaires at end of study (12 months)

Secondary

MeasureTime frame
Time to relapse measured using the number of days after first remission at end of study (12 months);Change in Sociodemographic and Clinical Variables measured using the difference in the value of predefined patient sociodemographic and clinical variables at baseline and the 12-month assessment;Social Network Size measured using the 6-item Lubben Social Network Scale (LSNS-6) at baseline, 3, 6, and 12 months;Quality of life for patients measured using the 5-dimension 5-level EuroQol Questionnaire (EQ-5D-5L) at baseline, 3, 6, and 12 months;Personal recovery for patients measured using the Questionnaire about the Process of Recovery (QPR) at 3, 6, and 12 months;Client satisfaction for patients measured using the Client Satisfaction Questionnaire (CSQ-8) at 3 and 12 months;Mental well-being for patients and caregivers measured using the World Health Organisation-Five Well-Being Index (WHO-5) at baseline, 6, and 12 months;Evaluation of social systems for patients and caregivers measured using the Evaluation of Social Systems Scale (EVOS) at baseline, 6, and 12 months;Caregiver burden of care for caregivers measured using the Burden Assessment Scale (BAS) at baseline, 6, and 12 months

Countries

France, Germany, Italy

Contacts

Public ContactFrancesca Camilli
francesca.camilli@istc.cnr.it+39 320 48696960

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026