Narrative Experiences Online (NEON): impact of recorded mental health recovery stories on quality of life in people experiencing psychosis
| ISRCTN | ISRCTN11152837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11152837 |
| Secondary identifying numbers | 249015 |
- Submission date
- 24/05/2018
- Registration date
- 13/08/2018
- Last edited
- 07/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
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 | 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 randomized allocation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| 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 |
| Study acronym | NEON |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 22/09/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 683 |
| Total final enrolment | 739 |
| Key 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 the previous 6 months 3. Resident in England 4. Aged 18 years 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 09/03/2020 |
| Date of final enrolment | 01/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Porchester Road
Mapperley
Nottingham
NG3 6AA
United Kingdom
Arundel Road
Worthing
BN13 3EP
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
Trust Headquarters
9 Alie Street
London
E1 8DE
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Dryden Road
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 |
|---|---|
| RandIenquiries@nottshc.nhs.uk | |
"ROR" |
https://ror.org/04ehjk122 |
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| 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 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 |
| 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 | ||
| Results article | 23/10/2024 | 07/11/2024 | Yes | No |
Editorial Notes
07/11/2024: Publication reference added.
09/09/2024: The intention to publish date was changed from 30/09/2024 to 30/11/2024.
19/02/2024: The intention to publish date was changed from 01/02/2024 to 30/09/2024.
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.
13/07/2023: The following changes were made to the trial record:
1. Two publication references that were not related to this study were removed.
2. Publication reference added.
27/06/2023: Publication reference added.
22/05/2023: Publication reference added.
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.
05/08/2021: Publication reference added.
12/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 01/03/2021.
2. The total final enrolment was added.
22/07/2020: Publication reference added.
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.
