Severe mental illness Mental and Behavioural Disorders
Conditions
Interventions
Overview
The research team will undertake a feasibility trial to assess whether it is possible to conduct a full-scale trial comparing Open Dialogue (OD) to Treatment as Usual (TaU). They will underta
Sponsors
North East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Clusters must: 1. Be in a catchment area with a clear referral pathway to the community mental health service 2. Have protocols in place to deliver either OD or TAU 3. Contain a set of 2 to 4 geographically coterminous GP practices where 3.1. The cluster has an average number of referrals per cluster between 65 and 75 patients per year to crisis services 3.2. Each practice has a list size of over 2000 registered persons 3.3. Each practice refers only within the catchment area of the community MH service 3.4. Each practice only serves residents within the cluster catchment area (i.e. does not include practices which, as one of its primary functions, have the provisions of a student health service) Service users from a cluster are eligible to take part in the study if they are: 1. Meeting criteria of a service user in crisis (meeting ICD criteria (WHO, 1992) for a mental health disorder) within 24-48 hours of referral or having been discharged from in-patient care following a crisis admission to the Crisis Resolution and Home Treatment Team (CRHTT) for home treatment. There will be some variability in the operational definition of ‘crisis’ across Trusts and, therefore, participants presenting to services. However, this variation will increase the generalisability of trial findings. 2. 18 years and above 3. Able to provide informed consent, or have consent provided by a personal or nominated consultee
Exclusion criteria
Exclusion criteria: 1. Having a diagnosis of dementia or a learning disability 2. Having a primary diagnosis of substance misuse 3. Having an acquired cognitive impairment 4. Being unable to comprehend both written and verbal English 5. Being under the care of forensic services 6. Being considered too high risk through participation in the study; that is, participation in the study is judged by the service users’ clinician to pose potential harm to themselves or the research/clinical team 7. Residing outside their GP catchment area 8. Having no fixed abode 9. Currently participating in another research trial, which could affect their participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility and acceptability of conducting a randomised controlled trial of the OD intervention versus TaU, the study will collect the following data: 1. Recruitment to the trial, measured by observing the number of participants after recruitment 2. Consent rate, measured using the number of participants providing full consent after screening 3. Retention rates, measured using the number of participants who remained in the study at the end of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability will be assessed through the successful completion of the following participant-level secondary outcome measures: The following measures are recorded at baseline: 1. Socio-demographics measured using data collected on a form created specifically for the trial, which records: date of birth, gender, ethnicity, country of birth, education, employment, marital status, and housing 2. Symptom severity measured using the Brief Psychiatric Rating Scale (BPRS) 3. Social network quality measured using the Social Provisions Scale (SPS), and social network size measured using the Lubben Social Network Scale - 6 item (LSNS-6) 4. Burden of care on caregivers measured using the Burden Assessment Scale (BAS) 5. Health-related quality of life measured using the EQ-5D-5L 6. Hospitalisation rate, defined as an inpatient admission post-index admission, and re-referral to Crisis Resolution and Home Treatment Teams (CRHTT), measured using data collected from anonymised patient electronic medical records The following outcome measures are recorded at 3-month follow-up: 8. Time to first relapse in days following recovery (primary outcome measure in the main trial), measured using anonymised case notes by the chief investigator, a psychiatrist and a senior clinician (to define point of recovery) 9. Service user and carer satisfaction with care, measured by the Client Satisfaction Questionnaire (CSQ-8) 10. Use of health, social care services and wider societal costs measured using an adapted version of the self-report Client Services Receipt Inventory (CSRI) 11. Service user and primary clinician experience of shared decision making during treatment, measured by patient and clinician self-report on the dyadic OPTION scale 12. Service user-defined recovery, measured by the Questionnaire about the Process of Recovery (QPR) | — |
Countries
England, United Kingdom
Contacts
Public ContactStephen Pilling
Outcome results
None listed