Condition category
Mental and Behavioural Disorders
Date applied
24/05/2018
Date assigned
13/08/2018
Last edited
02/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mental health recovery stories are first-person accounts of a journey of recovery from mental health problems. This study is developing theory to explain what recovery stories are and how they impact people (including an assessment of benefits and harms). The researchers are drawing on this theory to design an intervention in which selected recovery stories are presented online for the benefit of people experiencing psychosis. This study looks at whether receiving mental health recovery stories presented online improves quality of life for people with psychosis.

Who can participate?
Patients aged 18-65 who are currently experiencing psychosis and using mental health services in England

What does the study involve?
Participants are randomly allocated to either receive treatment as usual (e.g. from their secondary care team), or treatment as usual plus access to a collection of recorded recovery stories presented online. Participants can opt to receive a collection of stories recommended by an algorithm, to search for stories based on a set of tags, or to receive random stories. They can return to the online interface repeatedly over a one-year period. To assess the impact of receiving recovery stories, participant quality of life is assessed at the start of the study and after 1 week, 3 months and 1 year using a short online questionnaire. Online questionnaires are also used to track participants’ perceptions of hope, meaning in life, empowerment, the quality of their social relationships, and their mental health symptoms.

What are the possible benefits and risks of participating?
This study tests an intervention built around recovery stories and will have an impact on future clinical practice. Making a contribution to this evaluation and to the evolution of clinical practice might be perceived as a benefit of participation. Some participants will be randomly selected to receive recovery stories. For those participants, the opportunity to engage with the stories of peers might be perceived as a benefit. Engaging with recovery stories can be distressing, however, and this might be perceived as a risk for some participants.

Where is the study run from?
Nottinghamshire Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
August 2018 to April 2022

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Stefan Rennick-Egglestone
stefan.egglestone@nottingham.ac.uk

Trial website

http://www.researchintorecovery.com/research/neon/neon-trial

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

ClinicalTrials.gov number

Protocol/serial number

249015

Study information

Scientific title

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

Acronym

NEON

Study 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial 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

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

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

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

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

Patient

Age group

Adult

Gender

Both

Target number of participants

683

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/11/2019

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

Sponsor information

Organisation

Nottinghamshire Healthcare NHS Foundation Trust

Sponsor details

Duncan Macmillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
United Kingdom
+44 (0)1157484321
shirley.mitchell@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://www.ncbi.nlm.nih.gov/pubmed/31256037 (added 02/07/2019)

Publication citations

Additional files

Editorial Notes

02/07/2019: Publication reference added.