First episode psychosis Mental and Behavioural Disorders
Conditions
Interventions
People with first-episode psychosis will be randomised into one of two intervention arms: the Social Mind CBT intervention or Treatment as Usual (TAU)
Treatment arm 1: Social Mind Intervention + Trea
Sponsors
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who have received a diagnosis of first-episode psychosis using the Structured Clinical Interview for DSM-V Diagnosis 2. Having suffered from a first episode of psychosis (i.e. diagnosis received by an experienced clinician at the treating clinical team) 3. A minimum age of 18 years
Exclusion criteria
Exclusion criteria: 1. More than one previous episode of psychosis 2. A first episode that began more than 24 months prior to recruitment 3. Insufficient comprehension of the English language 4. Learning disability based on clinical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates measured in terms of the number of eligible participants who consent to participate in the study over a 14-month period 2. Follow-up rates measured in terms of the number of enrolled participants who take part in the 6-month follow-up 3. Acceptability will be assessed at the end of the last treatment sessions using the Treatment Acceptability Rating Form-Revised (TARF-R), consisting of 21 items on a seven-point Likert-type scale. In addition, qualitative data will be used to gain insight into why the trial was or was not acceptable to participants and how this aspect of the intervention could be enhanced in a full trial. 4. Safety will be assessed in terms of the frequency of adverse events. These will be monitored in terms of occurrence and severity throughout the trial using an unstructured log. This information will be collected from the clinical teams and retrospectively from the patient at each follow-up. 5. Treatment fidelity will be measured using the Revised-Cognitive Therapy for Psychosis Adherence Scale after each therapy session (a total of six times) 6. Estimates of sample size parameters for a subsequent full trial to be computed using standard power calculations at 6-month follow-up The researchers will use this information to refine the intervention and inform a subsequent full-scale randomised controlled trial (RCT) | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured at baseline, 3 months and 6 months: 1. Social functioning will be measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0). A further measure of social functioning will be collected using the Social Functioning Questionnaire 2. Measures of psychopathology will be collected using the SCID-Psychotic Symptoms, PANSS; Patient Health Questionnaire; Generalised Anxiety Disorder scale 3. Measures of cognition will be collected using the Perceived Criticism and Warmth Scale; Brief COPE; Brief Core Schema Scale; Young Schema Questionnaire 4. Measures of social behaviour will be collected using the UCLA Loneliness Scale; Social Connectedness Scale; Multidimensional Support scale; Interpersonal Sensitivity Scale; Quality of Life Health Questionnaire; Revised Psychosis Attachment Measure, and Perceived Stress Scales | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrea Mechelli
Outcome results
None listed