Condition category
Mental and Behavioural Disorders
Date applied
02/12/2019
Date assigned
09/01/2020
Last edited
10/03/2020
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 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 mental health 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 other people’s experiences. NEON is currently being trialled in individuals with experience of what can be called psychosis to investigate whether receiving access to mental health recovery narratives can provide benefits (http://www.isrctn.com/ISRCTN11152837).

The NEON-C trial will examine whether it is feasible to use the same intervention to provide benefits to people with experience of caring for people with mental health problems.

Who can participate?
People aged 18 years or over, who have experience informally caring for someone with mental health concerns in the past 5 years. Participants need to be competent in English and are able to use a computer or smartphone (with support if needed). Informal carers interested in taking part should not be accessing mental health services. The person cared for does not need to have received any medical support for their mental health concerns.

What does the study involve?
Taking part in NEON-C will involve being 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 will need to provide some information about themselves and their experiences, using some online forms, participants might also be invited to take part in an interview about their experiences, and their usage of the NEON Intervention will be logged. The information collected will help us to assess the success of the NEON Intervention, and to plan for a larger-scale trial with the same study population. We will publish our 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 their 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?
The study will run from 7 sites.
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-C Trial will open in January 2020, and participants can join the trial up until April 2021.

Who is funding the study?
The National Institute for Health Research (NIHR) in the United Kingdom.

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

IRAS Project ID: 249015

Study information

Scientific title

Narrative Experiences Online (NEON): Randomised controlled trial to test the feasibility of providing online recorded mental health recovery narratives to people with experience of caring for people with mental health problems , with a control of delayed access to recovery narratives (NEON-C Trial)

Acronym

NEON-C Trial

Study hypothesis

This is a feasbility trial which will develop knowledge to support the design of a future definitive trial.

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

Interventional randomised controlled trial with no masking delivered online with recruitment across England 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

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental health

Intervention

Participants will access the stories through an online interface called the NEON Intervention. The NEON Intervention draws on stories in the NEON Collection. This has been assembled from published to stories for which we have collected consent for use, and from donations of stories directly to the study.

Equal allocation across arms.
Arm 1: treatment as usual plus access to a collection of recorded recovery stories presented online for one year
Arm 2: treatment as usual for one year, followed by access to recorded recovery narratives

Randomisation:
In advance of trial start, an independent statistician will generate a file of random numbers, with properties as described in our protocol. This will be uploaded to the online interface, and used to randomly allocate participants.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Manchester Short Assessment (MANSA) of health-related quality of life, captured at 1 week, 12 weeks and 52 weeks (primary endpoint) after baseline.

Secondary outcome measures

Secondary outcome measures will be assessed at baseline, one week, 12 weeks and 52 weeks after baseline:
1. Hope will be assessed through the Herth Hope Index (Herth, 1992)
2. Meaning in Life will be assessed through the Meaning in Life Questionnaire (Steger et al, 2006)
3. Empowerment will be assessed through the Mental Health Confidence Scale (Carpinello et al, 2000)
4. Symptomatology will be assessed throughthe CORE-10 (Barkham et al., 2013)

Overall trial start date

06/08/2018

Overall trial end date

29/04/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or above
2. Any gender
3. Experience of being an informal carer for someone with experience of mental health problems within the last five years
4. Able to understand written and spoken English
5. Able to access or be supported to access the internet
6. Able to give online informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. If eligible for the NEON Trial (ISRCTN number11152837).
2. If eligible for the NEON-O Trial (ISRCTN pending).

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
Research@nottshc.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.nottinghamshirehealthcare.nhs.uk/

Funders

Funder type

Not defined

Funder name

National Institute for Healthcare Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists will publish the trial protocol, which will incorportate a statistical analysis plan.

Dissemination through
a. publication of trial report in a journal with an international audience
b. 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

Publication citations

Additional files

Editorial Notes

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 27/01/2020 to 31/01/2020. 03/12/2019: Trial’s existence confirmed by Leicester Central Research Ethics Committee