Severe mental illness Mental and Behavioural Disorders
Conditions
Interventions
This research is a cluster randomised trial of Open Dialogue (OD) compared to Treatment as Usual (TAU) for people who experience a mental health crisis (WP3). In the OD component of the trial a multi-
Sponsors
North East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Service users are eligible to participate in the study if they: 1. Are experiencing, or have recently experienced a mental health crisis, indicated by an A-C rating on the UK Mental Health Triage Scale or are admitted to an inpatient ward or taken on to a crisis service caseload 2. Are registered with one of the GP practices in a trial cluster 3. Are 18 years and above 4. Have sufficient English language abilities to participate in the research A purposive sample of 20% of trial participants will be invited to nominate a carer to complete some additional outcome measures, but this process is separate and does not impact eligibility for, or participation in the trial. Similarly, a purposive sample of participants (estimated to be 10% of the trial sample) and staff will be approached to complete an interview, focus group, or provide written information. Sections A17-2 to A21 and A27 to A35 of this IRAS form relate just to all trial participants, and the other sections relate to trial participants, as well as the carers of the subsample of trial participants and the staff.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/01/2022: Service users are not eligible if: 1. They have a diagnosis of dementia or a learning disability 2. They have a primary diagnosis of substance misuse 3. They have an acquired cognitive impairment 4. They are under the care of forensic services 5. They have no fixed abode 6. They are participating in another research trial which may impact on their care or treatment in the ODDESSI programme 7. Their participation in the study is judged to pose a risk of harm to themselves, study clinicians, or researchers 8. They have received Open Dialogue prior to the study ____ Previous exclusion criteria: Service users are not eligible if they: 1. Have a diagnosis of dementia or a learning disability 2. Have a primary diagnosis of substance misuse 3. Have an acquired cognitive impairment 4. Are under the care of forensic services 5. Have no fixed abode 6. Are participating in another research trial which may impact on their care or treatment in the ODDESSI programme 7. They will also be excluded if their participation in the study is judged to pose a risk of harm to themselves, study clinicians, or researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse following recovery (measured in days) assessed using an established method (Bebbington at al., 2006) via data extracted from medical records at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to initial recovery (measured in days from the date of crisis referral to the date there is a ‘change of status’ to recovery), assessed using the same method as the primary outcome (Bebbington et al., 2006) at 24 months 2. Days spent in recovery (measured as the total number of days between the point of the crisis referral and 24 months following crisis referral, where a person’s status was labelled as in ‘recovery’) using the same method as the primary outcome (Bebbington et al., 2006). 3. Days in hospital (measured as the total number of days between the point of the crisis referral and 24 months following crisis referral, where a person is an inpatient in a psychiatric hospital) 4. Self-rated recovery score measured using the Questionnaire on the Process of Recovery (QPR) (Law et al., 2004), at 3, 6, 12 and 24 months after index crisis referral 5. Service user satisfaction with care measured using the Client Satisfaction Questionnaire (CSQ-8) (Attkinsson & Greenfield, 1999) at 3, 6 and 24 months after index crisis referral 6. Cost-effectiveness of OD (compared to TAU) calculated by measuring service use costs, assessed using the Client Services Receipt Inventory (CSRI) (Beecham & Knapp) at 3, 12 and 24 months after index crisis referral. It will also measure societal costs, including hospitalisation or re-referral to crisis care, assessed at an individual participant level for the 24-month follow up period. It will also measure health-related quality of life, using the EQ-5D-5L at first assessment, and 3, 6, 12 and 24 months after index crisis referral. 7. Social network quality and size measured using the Social Provisions Scale (SPS) (Cutrona & Russell, 1987) and the Lubben Social Network Scale (LSNS-6) (Lubben et al., 2006) at first assessment, and 3, 6, 12 and 24 months after index crisis referral | — |
Countries
England, United Kingdom
Outcome results
None listed