Social Mind: improving social functioning in first episode psychosis
| ISRCTN | ISRCTN85485447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85485447 |
| IRAS number | 329378 |
| Secondary identifying numbers | IRAS 329378, CPMS 56467 |
- Submission date
- 30/01/2024
- Registration date
- 02/02/2024
- Last edited
- 18/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Mental health and social life are intrinsically connected. People with a first episode of psychosis (FEP) experience high levels of social stress, but none of the existing psychological interventions for psychosis focuses on social stress. This study will involve testing the feasibility of implementing Social Mind, a new psychological intervention aimed at helping patients understand and manage social stress, minimising the risk of social withdrawal and promoting social functioning. This is achieved by combining the cognitive appraisal of social stress and an active behavioural component involving real-life situations. Social Mind was co-developed by a diverse team including lived experience experts, mental health professionals and academics.
Who can participate?
Participants aged 18 years and over who have received a diagnosis of first-episode psychosis will be recruited via early intervention services for psychosis in two NHS Foundation Trusts: South London and Maudsley (SLaM) and Central and North West London (CNWL).
What does the study involve?
Participants are randomly allocated to receive Social Mind + Treatment as Usual (TAU) or TAU. Outcomes will assess the feasibility and acceptability of recruitment methods; the acceptability of assessment measures, intervention mode and intervention delivery; treatment fidelity; follow-up rates; and estimates of sample size parameters. The researchers will use this information to inform a full-scale randomised controlled trial.
What are the possible benefits and risks of participating?
Participants will receive a new psychosocial intervention which could help minimise social stress and improve social functioning. Following full validation, this study could lead to a new evidence-based intervention for improving social functioning in people with FEP. This would reduce the burden of the illness on service users, their families and clinical services.
Where is the study run from?
Institute of Psychiatry, Psychology & Neuroscience, King's College London (UK)
When is the study starting and how long is it expected to run for?
October 2023 to November 2026
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof. Andrea Mechelli, a.mechelli@kcl.ac.uk
Contact information
Public
Institute of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-6770-2934 |
|---|---|
| Phone | +44 (0)20 7848 0289 |
| a.mechelli@kcl.ac.uk |
Scientific, Principal Investigator
Institute of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
| ORCID ID |
0000-0001-9781-3531 |
|---|---|
| Phone | +44 (0)7904227009 |
| anna.georgiades@kcl.ac.uk |
Study information
| Study design | Feasibility randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A feasibility randomised control trial of Social Mind: a brief targeted intervention for reducing social stress and improving social functioning in first episode psychosis |
| Study acronym | Social Mind |
| Study hypothesis | Participants engaging in the Social Mind Intervention will demonstrate statistically significant reductions in social stress, psychosis symptoms, anxiety, and depression as well as improvements in social functioning compared to the treatment as usual (TAU) group. |
| Ethics approval(s) |
Approved 11/06/2024, London - Hampstead REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8345; hampstead.rec@hra.nhs.uk), ref: 24/LO/0363 |
| Condition | First episode psychosis |
| Intervention | 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 + Treatment As Usual Treatment arm 2: Treatment As Usual Social Mind Intervention: Social Mind is a psychosocial intervention based on Cognitive Behaviour Therapy (CBT) principles aimed at reducing social stress and improving social functioning in people with a first episode of psychosis. It comprises six one-to-one face-to-face sessions with a therapist. Each session is 60 minutes in duration and occurs once a week for 6 weeks. Session 1: Engagement & Assessment. Expected outcomes: engagement with therapist, goal identification, psychosocial stressors, appraisals, and coping Session 2 & 3: Appraisal of Stress & formulation development. Expected outcomes: formulation development, and starting to reappraise psychosocial stressors. Session 4 & 5: Behavioural Experiments: Expected outcomes: Introduce behavioural experiments to address psychosocial stressors, and introduce more adaptive ways of coping. Session 6: Review and Summarize. Expected outcomes: Consolidate learning, summarize the work, and devise a relapse prevention plan. Treatment As Usual: Participating NHS Trusts are implementing treatment as usual based on NICE guidelines, which involves the combination of antipsychotic medication and Cognitive Behavioural Therapy for Psychosis (CBTp) with or without Family Intervention. While this provides some degree of consistency, there will still be variation in TAU, for example when a patient declines one or more treatments offered to them. To assess such variation the researchers will monitor participants in both allocation groups for the following: antipsychotic medication and dosage; antidepressant medication and dosage; recipient of CBT and number of sessions; recipient of Family Intervention and number of sessions. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/10/2023 |
| Overall study end date | 01/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2024 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
27-29 Fairlight Avenue
Harlesden
London
NW10 8AL
United Kingdom
Early Intervention
St Giles House
St Giles Road
London
SE5 7UD
United Kingdom
Sponsor information
Hospital/treatment centre
Michael Rutter Centre
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)20 3228 6000 |
|---|---|
| slam-ioppn.research@kcl.ac.uk | |
| Website | http://www.slam.nhs.uk/ |
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | The aim is to disseminate via publications within scientific journals the outcome of this trial. If this psychological intervention produces significant effects on the outcome variables, the researchers intend to develop a treatment manual for clinicians and to develop a training course to accompany this treatment manual. |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be stored within the King's College London computer drives - a non-publicly available repository. The type of data stored: raw and processed data. The process for requesting access (if non-publicly available): data can be requested via email to Prof. Andrea Mechelli (a.mechelli@kcl.ac.uk). Dates of availability: the data will be made available once the results of the feasibility study are published (exact date to be confirmed). Whether consent from participants was required and obtained: Yes Comments on data anonymization: following the completion of the study, the data will be stored and made available to the wider research community in a fully anonymised format. Any ethical or legal restrictions: none. |
Editorial Notes
Ethics committee approval added.
04/03/2024: Internal review.
30/01/2024: Study's existence confirmed by the Medical Research Council.
