Plain English Summary
Background and study aims
Mental health recovery narratives are people’s stories of recovery from mental health problems. Recovery narratives can be presented in a form that cannot change, such as text, audio or video, in which case we have called them “recorded” recovery narratives. The Narrative Experiences ONline (NEON) Programme has been investigating whether receiving recorded recovery narratives can improve quality of life for people affected by mental health difficulties. NEON has identified a range of potential benefits, including feeling more hopeful or connected to others, and learning about how others have recovered from mental health difficulties. The aim of the NEON Trial is to understand whether receiving online recorded recovery narratives benefits people with experience of what can be called psychosis.
Who can participate?
People aged 18 or over, who have experienced what can be called psychosis in the last five years, who are competent in English, and who can use a computer or smartphone (with support if needed). Participants do not need to have received any medical support for their mental health difficulties.
What does the study involve?
Participants are randomly allocated to either receive access to the NEON Intervention, an interactive website providing access to hundreds of recovery narratives, or to receive access to the NEON Intervention after one year. Participants can use the NEON Intervention as much or as little as they want. At four points during the year, participants provide some information about themselves and their experiences using online forms. This information will help the researchers to assess the success of the NEON Intervention, and they will publish their results in publications which are available to all.
What are the possible benefits and risks of participating?
Benefits include obtaining access to a diverse set of recovery narratives assembled by the NEON study team, and making a contribution to research which will shape clinical practice. Some recovery narratives might help participants feel more hopeful about your own future, or more connected to others with similar experiences. People can sometimes experience distress as they read, watch or listen to a recovery narrative, but this is typically short-lived. There is some evidence that encountering descriptions of self-harm in recovery narratives might contribute to recipients emulating these behaviours if they are at risk of self-harm.
Where is the study run from?
1. Nottinghamshire Healthcare NHS Foundation Trust (UK)
2. Sussex Partnership NHS Foundation Trust (UK)
3. Lincolnshire Partnership NHS Foundation Trust (UK)
4. East London NHS Foundation Trust (UK)
5. South London and Maudsley NHS Foundation Trust (UK)
6. Derbyshire Healthcare NHS Foundation Trust (UK)
7. Devon Partnership NHS Foundation Trust (UK)
8. North East London NHS Foundation Trust (UK)
9. Oxford Health NHS Foundation Trust (UK)
10. Leicestershire Partnership NHS Trust (UK)
11. Cornwall Partnership NHS Foundation Trust (UK)
12. Somerset Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
The NEON Trial will open in January 2020, and participants can join the trial up until April 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Stefan Rennick-Egglestone
stefan.egglestone@nottingham.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Dr Stefan Rennick-Egglestone
ORCID ID
http://orcid.org/0000-0003-4187-011X
Contact details
Institute of Mental Health
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 (0)115 82 30926
stefan.egglestone@nottingham.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
249015
Study information
Scientific title
The Narrative Experiences Online (NEON) trial: a two-arm randomised controlled trial in which people with experience of psychosis receive access to (arm 1) versus receive one year delayed access to (arm 2) recorded mental health recovery narratives delivered online, with quality of life as a primary outcome, and hope, empowerment, meaning in life and symptomatology as secondary outcomes
Acronym
NEON
Study hypothesis
Current hypothesis as of 12/11/2019:
Participants receiving access to mental health recovery narratives will have improved quality of life at one-year follow-up compared with those not receiving access to mental health recovery narratives in this period.
Previous hypothesis:
Participants receiving mental health recovery stories will have improved quality of life at one-year follow-up compared with those not receiving mental health recovery stories.
Ethics approval(s)
Approved 13/12/2019, Leicester Central Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; Tel: +44 (0)207 104 8234; Email: NRESCommittee.EastMidlands-LeicesterCentral@nhs.net), REC ref: 19/EM/0326
Study design
An interventional trial, with no masking, delivered online with recruitment across England, a control of treatment as usual for one year followed by access to the intervention, and 1:1 randomised allocation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Mental health
Intervention
Current interventions as of 12/11/2019:
Equal allocation across arms:
Arm 1: treatment as usual plus access to online recovery narratives for one year
Arm 2: treatment as usual for one year, followed by access to recorded recovery narratives
Previous interventions:
An interventional trial, with no masking, delivered online with recruitment across England, and 1:1 randomised allocation stratified for severity of condition. Randomisation will be through an algorithm that uses a generic random number generation library.
Arm 1: treatment as usual plus access to a collection of recorded recovery stories presented online for 1 year
Arm 2: treatment as usual for 1 year
Duration of treatment: 1 year. No follow up beyond the end of the treatment period.
Intervention type
Other
Primary outcome measure
Current primary outcome measure as of 12/11/2019:
Health-related quality of life assessed using the Manchester Short Assessment (MANSA) at 1 week, 12 weeks and 52 weeks (primary endpoint) after baseline
Previous primary outcome measure:
Health-related quality of life assessed using the Manchester Short Assessment (MANSA) at 1 week, 3 months and 1 year after baseline
Secondary outcome measures
Current secondary outcome measures as of 12/11/2019:
Assessed at 1 week, 12 weeks and 52 weeks after baseline:
1. Hope assessed through the Herth Hope Index (Herth, 1992)
2. Meaning in Life assessed through the Meaning in Life Questionnaire (Steger et al, 2006)
3. Empowerment assessed through the Mental Health Confidence Scale (Carpinello et al, 2000)
4. Symptomatology assessed through CORE-10 (Barkham et al, 2013)
Previous secondary outcome measures:
Assessed at 1 week, 3 months and 1 year after baseline:
1. Hope assessed through the Herth Hope Index (Herth, 1992)
2. Meaning in life assessed through the Meaning in Life Questionnaire (Steger et al, 2006)
3. Empowerment assessed through the Mental Health Confidence Scale (Carpinello et al, 2000)
4. Symptomatology assessed through a standardised measure (to be determined)
5. Quality of social relationships assessed through a non-standardised scale to be developed within the NEON study
Overall study start date
06/08/2018
Overall study end date
22/09/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 12/11/2019:
1. Experience of psychosis in the last five years
2. Experience of mental health-related distress in previous 6 months
3. Resident in England
4. Aged 18 or above
5. Capable of accessing or being supported to access the internet, either on a personal computer, mobile device or at a community venue
6. Able to understand written and spoken English
7. Capable of providing online informed consent
8. Any gender
Previous inclusion criteria:
1. Aged 18-65
2. Any gender
3. Primary or secondary clinical diagnosis of psychosis (including e.g. schizophrenia, schizoaffective disorder, bipolar disorder)
4. Currently using mental health services in England
5. Able to understand English
6. Able to access or be supported to access the internet
7. Able to give online informed consent
Participant type(s)
Other
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
683
Total final enrolment
739
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
09/03/2020
Recruitment end date
01/03/2021
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Nottinghamshire Healthcare NHS Foundation Trust
Duncan Macmillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
United Kingdom
Study participating centre
Sussex Partnership NHS Foundation Trust
Swandean
Arundel Road
Worthing
BN13 3EP
United Kingdom
Study participating centre
Lincolnshire Partnership NHS Foundation Trust
St George's
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
Study participating centre
East London NHS Foundation Trust
Robert Dolan House
Trust Headquarters
9 Alie Street
London
E1 8DE
United Kingdom
Study participating centre
South London and Maudsley NHS Foundation Trust
Bethlem Royal Hospital
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
Study participating centre
Derbyshire Healthcare NHS Foundation Trust
Ashbourne Centre
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Study participating centre
Devon Partnership NHS Foundation Trust
Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom
Study participating centre
North East London NHS Foundation Trust
The West Wing
CEME Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Study participating centre
Oxford Health NHS Foundation Trust
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Study participating centre
Leicestershire Partnership NHS Trust
HQ Bridge Park Plaza
Bridge Park Road
Thurmaston
Leicester
LE4 8PQ
United Kingdom
Study participating centre
Cornwall Partnership NHS Foundation Trust
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Study participating centre
Somerset Partnership NHS Foundation Trust
2nd Floor, Mallard Court
Express Park
Bristol Road
Bridgwater
TA6 4RN
United Kingdom
Sponsor information
Organisation
Nottinghamshire Healthcare NHS Foundation Trust
Sponsor details
Duncan Macmillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
England
United Kingdom
+44 (0)1157484321
RandIenquiries@nottshc.nhs.uk
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The trialists will publish the trial protocol, which will incorporate a statistical analysis plan.
Dissemination through:
1. Publication of trial report in a journal with an international audience
2. Publication of a lay summary through the study website
Intention to publish date
30/09/2024
Individual participant data (IPD) sharing plan
Current participant level data sharing statement as of 20/10/2023:
Data access is controlled to protect the confidentiality of trial participants, and in particular to avoid re-identification through combination of multiple data files. Data will be available on reasonable request until the end of the retention period, supervised by the study sponsor. After the retention period, availability through the study sponsor or Chief Investigator may be provided at their discretion. Contact the study sponsor through Research@nottshc.nhs.uk citing IRAS ID 249015. To obtain access, an end-user license must be signed by an authorised representative. Requests can be denied if the sponsor has reason to believe that the requestor has malicious intent, and whilst research publications are being generated by the study team or investigators. Only anonymous and pseudonymous elements of the datasets used or analysed during the study will be available. Informed consent information has been retained for audit but will not be shared. Some categories of demographic data will be redacted to avoid re-identification. A data dictionary will be provided.
_____
Previous participant level data sharing statement:
Enquiries should be addressed to m.slade@nottingham.ac.uk, or to the Research and Innovation department of the study sponsor, Nottinghamshire Healthcare NHS Foundation Trust. The trialists will provide a statement clarifying data availability in their published trial protocol.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/07/2020 | 22/07/2020 | Yes | No |
| Statistical Analysis Plan | 20/05/2023 | 22/05/2023 | Yes | No | |
| Other publications | Development and delivery cost | 07/11/2022 | 27/06/2023 | Yes | No |
| Interim results article | Baseline data analysis | 27/06/2023 | 13/07/2023 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |