Condition category
Mental and Behavioural Disorders
Date applied
24/05/2018
Date assigned
13/08/2018
Last edited
15/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

http://www.researchintorecovery.com/neontrial

Contact information

Type

Scientific

Primary contact

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 number

Nil known

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

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

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not yet approved

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

Phase

Drug names

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 trial start date

06/08/2018

Overall trial end date

29/04/2022

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

Other

Age group

Adult

Gender

Both

Target number of participants

683

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

09/03/2020

Recruitment end date

30/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Foundation Trust
Duncan Macmillan House Porchester Road Mapperley
Nottingham
NG3 6AA
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Swandean Arundel Road
Worthing
BN13 3EP
United Kingdom

Trial participating centre

Lincolnshire Partnership NHS Foundation Trust
St George's Long Leys Road
Lincoln
LN1 1FS
United Kingdom

Trial participating centre

East London NHS Foundation Trust
Robert Dolan House Trust Headquarters 9 Alie Street
London
E1 8DE
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Bethlem Royal Hospital Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom

Trial participating centre

Derbyshire Healthcare NHS Foundation Trust
Ashbourne Centre Kingsway Hospital Kingsway
Derby
DE22 3LZ
United Kingdom

Trial participating centre

Devon Partnership NHS Foundation Trust
Wonford House Dryden Road
Exeter
EX2 5AF
United Kingdom

Trial participating centre

North East London NHS Foundation Trust
The West Wing CEME Centre Marsh Way
Rainham
RM13 8GQ
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
Warneford Hospital Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
HQ Bridge Park Plaza Bridge Park Road Thurmaston
Leicester
LE4 8PQ
United Kingdom

Trial participating centre

Cornwall Partnership NHS Foundation Trust
Carew House Beacon Technology Park Dunmere Road
Bodmin
PL31 2QN
United Kingdom

Trial 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
United Kingdom
+44 (0)1157484321
RandIenquiries@nottshc.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

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

IPD 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.

Intention to publish date

30/09/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 qualitative study results in https://pubmed.ncbi.nlm.nih.gov/31256037/ (added 15/06/2020)

Publication citations

Additional files

Editorial Notes

15/06/2020: Publication reference added. 10/03/2020: Trial participating centres added: North East London NHS Foundation Trust, Oxford Health NHS Foundation Trust, Leicestershire Partnership NHS Trust, Cornwall Partnership NHS Foundation Trust, Somerset Partnership NHS Foundation Trust. 25/02/2020: The recruitment start date was updated from 31/01/2020 to 09/03/2020. 21/01/2020: Ethics approval details added, recruitment start date changed from 14/01/2020 to 31/01/2020. 25/11/2019: Internal review. 14/11/2019: The link https://www.ncbi.nlm.nih.gov/pubmed/31256037 was removed from the publication list as it does not include results or protocol of this study. 12/11/2019: The following changes were made to the trial record: 1. The scientific title was changed from 'Narrative Experiences ON-line (NEON): a two-arm randomised controlled trial in which people experiencing psychosis receive (arm 1) versus do not receive (arm 2) online access to recorded mental health recovery stories, with a primary outcome measure of quality of life, and secondary outcome measures of hope, empowerment, meaning in life, quality of social relationships and symptomatology' to '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' 2. The study hypothesis, ethics approval, interventions, primary and secondary outcome measures, trial website, participant information sheet, inclusion criteria, plain English summary and sponsor contact details fields were all updated. 3. The study design was changed from 'Randomised controlled trial' to '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.' 4. The recruitment start date was changed from 01/11/2019 to 14/01/2020. 5. Trial participating centres added: Sussex Partnership NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust, East London NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Derbyshire Healthcare NHS Foundation Trust, Devon Partnership NHS Foundation Trust. 02/07/2019: Publication reference added.