Feasibility trial of a structured intervention for expanding social networks in psychosis

INTERVENTION: Patients will be randomised to either the intervention or control. The allocation ratio will be 2:1 in favour of the intervention. Randomisation will be stratified by NHS Trust, ensuring balance between groups in the patient numbers from each NHS Trust. Blocked randomisation with a block size of m=3 will be used within each stratum. A fixed block size of m=3 is appropriate in this trial as the feasibility of intervention and study procedures is of primary interest and not intervention effects. Should blocked randomisation be used in the full trial a variable block size would be utilised. The randomization will be carried out remotely by the Pragmatic Clinical Trials Unit at Queen Mary, University of London. 11 clinicians will be asked to deliver the intervention ('social contacts coaching') to a small number of patients. 36 participants with psychosis will be randomised to receive either the intervention or information about events and social groups in their area (24:12). The intervention group will receive support from a mental health professional to try an activity of their choice, which involves meeting new people. Type and frequency of meetings Patients will be identified from mental health teams' caseloads and will be offered the intervention if they do not show substantial risk to self or others and this should be monitored as per routine clinical practice. The clinician delivering the intervention will not be the treating clinician of the patient. Clinicians should meet patients six times over the six‐month intervention period; about once per month. The intervention should start with a sufficiently long first two meetings (about 60 minutes) in the first month to explore preferences, discuss options in detail and agree on the way forward. The following meetings should discuss progress and provide support as required. They should last at least 20 minutes. Furth CONDITION: Specialty: Mental Health, Primary sub‐specialty: Psychosis; UKCRC code/ Disease: Mental health/ Organic, including symptomatic, mental disorders ; Mental and Behavioural Disorders ; Unspecified nonorganic psychosis PRIMARY OUTCOME: Quality of life measured by the Manchester Short Assessment for Quality of Life (Priebe et al., 1999) at baseline and at 6 months SECONDARY OUTCOME: ; 1. The number and quality of social contacts on each day of the previous week will be measured using Social Contacts (SCA) (Giacco et al., 2016), including detailed questions about social activities as developed in the ongoing PGfAR VOLUME (on volunteering in mental health) and including questions of the Time Use Survey (Priebe et al., 2016) at baseline and at 6 months; 2. Positive and negative symptoms assessed using the Positive and Negative Syndrome Scale (PANSS, Kay 1991 and Clinical Assessment Interview for Negative Symptoms (CAINS, Kring et al., 2013) at baseline and at 6 months; 3. Loneliness assessed using UCLA‐8 (Hays and DiMateo, 1987) at baseline and at 6 months; INCLUSION CRITERIA: Patients: 1. 18‐65 years old 2. Diagnosis of psychosis‐related condition (ICD‐10 F20‐29) 3. Capacity to provide informed consent 4. Ability to communicate in English 5. Limited social network size and low quality of life (Score less than 5 on MANSA quality of life assessment and less than 7 consecutive days with social contacts in the previous week) Clinicians: 1. Mental health professional with experience of providing community mental health care (e.g. psychiatrists, clinical psychologists, nurses, occupational therapists) 2. Aged 18‐65 years old 3. Employed by participating NHS Trusts 4. Capacity to provide informed consent 5. Ability to communicate in English