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

ISRCTN	ISRCTN93047402
DOI	https://doi.org/10.1186/ISRCTN93047402
Secondary identifying numbers	38036

Submission date: 30/05/2018
Registration date: 11/12/2018
Last edited: 07/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Psychosis affects a large number of people (1-2% of the population), can last for decades and cause much distress to patients. Although patients who have psychosis receive medication, practical support and sometimes talking therapies, these treatments have limited benefit and many patients remain socially isolated. Previous studies have social isolation is associated with poor quality of life. The aim of this study is to test in a small sample of patients (36) with psychosis whether it is possible to engage patients in a newly developed intervention to increase their social contacts, and to see how its benefits can be assessed compared to the care that patients usually receive. This small study will help with the design of a larger trial to receive a definitive answer of whether the intervention is more beneficial than usual care.

Who can participate?
Patients aged 18 to 65 with a diagnosis of psychosis who have less than two social contacts outside home, work or services and who have a poor quality of life

What does the study involve?
Nine clinicians in three NHS mental health Trusts (East London NHS Foundation Trust, Devon Partnership NHS Foundation Trust and Tees, Esk and Wear Valleys NHS Foundation Trust) deliver the intervention (social contacts coaching) to 36 patients overall. The patients are randomly allocated to receive either the intervention or only information about events and social groups in their area. People who receive the intervention receive support from a mental health professional to try an activity of their choice, which involves meeting new people. All patients and clinicians are interviewed about their experience of receiving or delivering the intervention. Patients are also interviewed about their social contacts and activities, symptoms and quality of life before and after the intervention.

What are the possible benefits and risks of participating?
There may be benefits towards reducing social isolation for both patients in both groups. However, this has not been studied yet and cannot be guaranteed. Risks of participating are minimal as all patients will keep receiving their standard care and procedures are in place to respond to arising distress due to participation and to preserve confidentiality of participants.

Where is the study run from?
The lead team is at East London NHS Foundation Trust, which covers three boroughs (Newham, Tower Hamlets and Hackney) of London. Other sites are within the areas covered by the Devon Partnership NHS Foundation Trust and the Tess, Esk and Wear Valleys NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
February 2018 to February 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Agnes Chevalier (Programme Manager)
agnes.chevalier@nhs.net
2. Domenico Giacco (co-lead investigator)
domenico.giacco@nhs.net

Study website

Contact information

Dr Domenico Giacco
Scientific

Unit for Social & Community Psychiatry
Queen Mary University of London
East London NHS Foundation Trust
Newham Centre for Mental Health
London
E13 8SP
United Kingdom

ORCID ID	0000-0001-7809-8800
Phone	+44 (0)2075404380 ext. 2319
Email	d.giacco@qmul.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Treatment
Participant information sheet	See additional files
Scientific title	Feasibility trial of a structured intervention for expanding social networks in psychosis
Study acronym	SCENE (Work Package 4)
Study objectives	Psychosis affects a large number of people (1-2% of the population), can last for decades and cause much distress to patients and carers. Although patients receive medication, practical support and sometimes talking therapies, these treatments have limited benefit and many patients remain socially isolated. Previous studies have shown that small social networks are associated with poor quality of life. The trialists would like to test the feasibility of an intervention to expand patients’ social networks and consequently improve their quality of life. In this specific study they will carry out a feasibility study, further refining the intervention, in order to gain more systematic practical experience of its provision within the NHS. The study will be carried out at different sites in order to make the intervention applicable to different (urban and rural) areas. The study sites will be East London, North East of England (York and surrounding area), and Devon.
Ethics approval(s)	London - Surrey Research Ethics Committee, 14/05/2018, IRAS ID: 243201, REC ref: 18/LO/0520
Health condition(s) or problem(s) studied	Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental health/ Organic, including symptomatic, mental disorders
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. Further contacts of clinicians with patients, as needed via telephone, text messages, Skype or other electronic means, will be encouraged. Such contacts may also replace face-to-face contacts, but the initial meeting and at least one more meeting will be face-to-face. The location of these meetings can vary and depend on patient preference and local circumstances (including patients’ homes, community places and offices of services). Content of meetings The meetings should focus on the patient’s motivation to expand social networks, their preferences for how to do this, local options for doing this and plans for how to achieve it in practice. This may include temporary support through the intervention (e.g. reminders, initial accompanying). The planned activities should be a way to expand social networks, e.g. leisure activities in groups rather than going to the cinema on their own. This will usually mean establishing new contacts, but could also be engaging in new joint activities with previous contacts (outside on-going friends and close family). The intervention will not address potential difficulties in already existing on-going relationships (e.g. with close family). The meetings should start with a review of progress and should end with an agreement on actions to be taken. This will then be reviewed and possibly revised at further meetings. Normally, the agreement should not specify more than one type of concrete activity at a time. If a patient expresses interest in more than one activity, they should be asked to choose one to prioritise. If there is no substantial progress after three months with one type of activity, an agreement should be made to switch to a different activity. There will be some flexibility about when exactly the switch should be considered and agreed. The switch should be agreed by both patient and clinicians in a face-to-face meeting. Who will deliver the intervention The intervention will be delivered by employed NHS clinicians who are clinically qualified (e.g. psychiatrists, psychologists, nurses, occupational therapists) and have experience in delivering psycho-social interventions. Training of clinicians Clinicians will be trained in the intervention in one session of up to three hours, flexibly in either a group format or individual format by a senior member of the core research team. When and if required, depending on the previous experience, additional one-to-one training can be provided. During the training they will acquire knowledge of the structure and aims of the intervention, i.e. number of sessions, frequency of sessions and procedures to help the patients to reach out to social activities. They will also be taught simple motivational interviewing techniques. Scenarios in which barriers for the patient in engaging in new social contacts may appear and strategies to overcome them will be discussed. Knowledge about the local context will be helped by a list of possible local options for low cost activities in the local area available to the patient that involve contacts with other people. This list will be provided by the research team. Clinicians will also be expected to and supported in obtaining a good knowledge about the options and encouraged to network in the given community to generate more options for relevant activities. Learning progress will be assessed during the training and in the subsequent supervision, provided by senior members of the research team, which will be organised flexibly in order to identify the ideal frequency. At the end of the case studies, clinicians who have delivered the intervention will receive an in-depth interview and will be encouraged to provide suggestions for further refinement of the intervention, of the training and of the supervision arrangements. Further support of clinicians Clinicians will receive updates on changes in options for activities from the local research team and from participating clinicians themselves through networking. They will also be supervised through regular phone calls (at least once a month or more if and as required) either locally or centrally from the study team in London. Recording of intervention sessions For each clinician, we will aim to audio-record two interventions sessions (if the patients consent to this). They will be helpful to understand what are the topics and activities discussed during the intervention sessions and to identify ways to help motivation and commitment of patients to social activities in order to help specify training guidelines and obtain examples to be used for a training package. Control group Patients in the control group will be provided with comprehensive information about local options for social activities by the researcher. This condition is intended to control for the provision of information and non-specific attention through a professional in addition to routine care. Also, the mere provision of information should be regarded as good practice independent of additional targeted interventions, so that patients in the control group should receive it too. The usual treatment, including care-coordination, medication, and psychological therapies, will not be affected, neither in the intervention nor in the control group. The trialists will then interview patients and clinicians about their experience of receiving or delivering the intervention. Patients will also be interviewed about their social contacts and activities, symptoms and quality of life before and after the intervention. The data collected will help to see whether the definitive intervention is more beneficial than normal care and to gain further and more systematic practical experience with the intervention in the NHS in preparation for a full randomised controlled trial.
Intervention type	Behavioural
Primary outcome measure	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 measures	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
Overall study start date	01/06/2018
Completion date	28/02/2019

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	Planned sample size: 45 (36 patients and 9 clinicians); UK sample size: 45
Total final enrolment	36
Key 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
Key exclusion criteria	Patients: 1. Does not meet inclusion criteria 2. Primary problem of current drug addiction 3. No capacity to provide written informed consent 4. An inpatient on a psychiatric ward at the time of recruitment Clinicians: 1. Does not meet inclusion criteria
Date of first enrolment	07/06/2018
Date of final enrolment	24/09/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

East London NHS Foundation Trust

9 Alie Street
London
E1 8DE
United Kingdom

Devon Partnership NHS Trust

Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom

Tees, Esk and Wear Valleys NHS Foundation Trust

West Park Hospital
Edward Pease Way
Darlington County
Durham
DL2 2TS
United Kingdom

Sponsor information

Noclor, East London NHS Foundation Trust
Hospital/treatment centre

1st Floor, Bloomsbury Building
St Pancras Hospital, 4 St. Pancras Way
London
NW1 0PE
England
United Kingdom

Phone	+44 (0)2033173045
Email	sponsor.noclor@nhs.net
Website	https://www.noclor.nhs.uk/
"ROR"	https://ror.org/01q0vs094

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0615-20009

No information available

Results and Publications

Intention to publish date	01/02/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Throughout all phases of the research, we will disseminate information about the activities of the programme through social media and a project specific website (http://scene.elft.nhs.uk/) in order to reach a wider public audience. The website will provide information for patients, professionals and service commissioners; and will be linked to other websites of local authorities, the participating NHS Trusts, and the academic institutions of the applicants. When results become available, they will be disseminated through: 1. Scientific publications in peer-reviewed open access journals 2. Presentations at national and international conferences and to professional and non-professional audiences at appropriate events 3. Existing networks, in particular: 3.1. The WHO, utilising the status of the Unit for Social and Community Psychiatry at QMUL as a WHO Collaborating Centre 3.2. The NHS, e.g. the benchmarking network in mental health which is currently co-ordinated by East London NHS Foundation Trust 3.3. The organisation involved in specific Quality Improvement programmes in health care 3.4. Different professional networks of the applicants; 4. Workshops and presentations at meetings that are held either as regular events (e.g. East London Mental Health Research Presentation Day, Showcase Conferences of CLRN) or specifically organised at different NHS locations; 5. Responding to invitations for presentations in different organisations
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Domenico Giacco (d.giacco@qmul.ac.uk). Data will be pseudo-anonymised, whereby all participants will be assigned a participant ID number and this will be used for all data processing purposes. No person-identifiable data will be shared. The data will be available until November 2022, and will only be shared with other researcher for the purpose of systematic reviews and meta-analyses.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version V2	30/04/2018	02/04/2019	No	No
Basic results		07/08/2020	07/08/2020	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN93047402_PROTOCOL_30Apr18_V2.docx: Uploaded 02/04/2019
ISRCTN93047402_BasicResults_07Aug2020.pdf: uploaded 07/08/2020

Editorial Notes

07/08/2020: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment was added.
06/08/2020: The intention to publish date was changed from 28/02/2020 to 01/02/2021.
02/04/2019: Uploaded protocol (not peer reviewed).
11/12/2018: The participant information sheet has been uploaded.