Open Dialogue: Development and Evaluation of a Social Network Intervention for Severe Mental Illness (ODDESSI)

orth East London NHS Foundation Trust0 个研究点目标入组 644 人开始时间: 2019年12月20日最近更新: 2023年10月3日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34958932/ (added 30/12/2021)

•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.

•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

发起方

orth East London NHS Foundation Trust