NEON-C: Trial to test the feasibility of providing online recorded mental health recovery stories to people with experience of caring for people with mental health problems
| ISRCTN | ISRCTN76355273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76355273 |
| IRAS number | 249015 |
| Secondary identifying numbers | IRAS Project ID: 249015 |
- Submission date
- 02/12/2019
- Registration date
- 09/01/2020
- Last edited
- 13/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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.
Contact information
Scientific
Institute of Mental Health
Triumph Road
Nottingham
NG7 2TU
United Kingdom
 ORCID ID |
0000-0003-4187-011X |
|---|---|
| Phone | +44 (0)115 82 30926 |
| stefan.egglestone@nottingham.ac.uk |
Study information
| Study design | Interventional randomized controlled trial with no masking delivered online with recruitment across England control of treatment as usual for 1 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 | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study 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(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 |
| 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 |
| 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 study start date | 06/08/2018 |
| Overall study end date | 22/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 54 |
| Participant inclusion criteria | 1. Aged 18 years 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 exclusion criteria | 1. If eligible for the NEON Trial (ISRCTN11152837). 2. If eligible for the NEON-O Trial (ISRCTN63197153). |
| Recruitment start date | 09/03/2020 |
| Recruitment end date | 26/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Nottingham
NG3 6AA
United Kingdom
Worthing
BN13 3EP
United Kingdom
Lincoln
LN1 1FS
United Kingdom
London
E1 8DE
United Kingdom
Beckenham
BR3 3BX
United Kingdom
Derby
DE22 3LZ
United Kingdom
Exeter
EX2 5AF
United Kingdom
CEME Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Bridge Park Road
Thurmaston
Leicester
LE4 8PQ
United Kingdom
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Express Park
Bristol Road
Bridgwater
TA6 4RN
United Kingdom
Sponsor information
Hospital/treatment centre
Duncan Macmillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
England
United Kingdom
| Phone | +44 (0)1157484321 |
|---|---|
| Research@nottshc.nhs.uk | |
| Website | https://www.nottinghamshirehealthcare.nhs.uk/ |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists will publish the trial protocol, which will incorporate a statistical analysis plan. Dissemination through: 1. Publication of a trial report in a journal with an international audience 2. Publication of a lay summary through the study website |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/07/2020 | 22/07/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 23/01/2024 | 13/02/2024 | Yes | No |
Editorial Notes
13/02/2024: Publication reference added.
20/10/2023: The following changes were made to the trial record:
1. The participant level data sharing statement was changed.
2. The intention to publish date was changed from 31/12/2022 to 01/02/2024.
23/09/2022: The overall end date was changed from 30/06/2022 to 22/09/2022.
22/09/2022: The following changes were made to the trial record:
1. The overall end date was changed from 29/04/2022 to 30/06/2022.
2. The intention to publish date was changed from 30/09/2022 to 31/12/2022.
12/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 26/03/2021.
2. The total final enrolment was added.
22/07/2020: 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 27/01/2020 to 31/01/2020.
03/12/2019: Trial’s existence confirmed by Leicester Central Research Ethics Committee
