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DepressionREBOOTNCT02902159

RCT of the Effectiveness of Big White Wall Compared to Other Online Support

A study testing BWW Online Peer Support and NHS Moodzone Online Information in people with Depression and Anxiety, run by University of Nottingham at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomised controlled trial to compare the effect on wellbeing of an online peer review website (Big White Wall) compared to freely available online information (NHS Moodzone) for people with depression and anxiety. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
BWW Online Peer Support and NHS Moodzone Online Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,200 participants
Where
2 sitesUnited Kingdom
Study dates
Sep 2016to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged 16+
  • Live in the County of Nottinghamshire, including Nottingham City
  • Scores between10-20 on the Personal Health Questionnaire (PHQ9) and/or 10+ on Genral Anxiety Disorder Scale (GAD7)
  • Access to internet through a pc or smartphone (Windows, iOS, Android)
  • Able and willing to give informed consent

Who cannot join

  • Scores 21 or more on the PHQ-9 (severe depression)
  • And /Or Scores 2 or 3 on PHQ-9 item "thoughts that you would be better off dead or of hurting yourself in some way".
  • Participant does not feel that they are sufficiently proficient in the use of the English Language (BWW and Moodzone are only available in English)

Trial locations and contacts

2 sites in 1 country.

Catherine J Kaylor-Hughes, DPhil contact

+441158232478

catherine.kaylor-hughes@nottingham.ac.uk

United Kingdom2 sites, 2 recruiting
  • Nottinghamshire Healthcare NHS foundation Trust.

    Nottingham, Nottinghamshire, NG3 6AA

    Recruiting
  • Nottingham University Hospitals Nhs Trust

    Nottingham, Nottinghamshire, NG7 2UH

    Recruiting

Other trials in United Kingdom

About this study

Official title: Randomised Controlled Trial of an Established Direct to Public Peer Support and E-therapy Programme (Big White Wall) Versus Information to Aid Self-management of Depression and Anxiety.

A randomised controlled trial to compare the effect on wellbeing of an online peer review website (Big White Wall) compared to freely available online information (NHS Moodzone) for people with depression and anxiety.

Read the detailed description

Introduction

Unipolar depression and anxiety are respectively the second and seventh leading causes of years lived with disability in the world among all health problems according to the World Health Organisation. Self-support methods of management of depression and anxiety through a population approach such as online therapy and peer support is attractive for a number of reasons including: the scale of the problem and the ability of current services to cope; providing choice about the management of their symptoms; creating personal empowerment; developing supportive social networks; recurrence prevention.

The use of public health interventions for physical conditions such as cigarette smoking, weight loss and diabetes is increasingly utilised and effective in reaching the wider public.

Big White Wall

Big White Wall (BWW) is a well-established digital service (website and apps) 3 that offers:

  • Online assessment of mental health problems and physical co-morbidities
  • Moderated on-line peer support
  • Guided support and live therapy

It is based on public health principles, emphasises a recovery model to improve well-being and is based theoretically on a social model of depression emphasising autonomy, hopefulness and support.

There are no waiting lists, eligibility criteria and opening hours (available 24/7).

It operates a community principle that each person is supported within cultures of respect, tolerance, mutual learning and safety, and procedures such as specially trained counsellors employed by BWW as "wall guides" try to ensure that this principle is maintained.

Patterns of use are often short-term over 3 to 6 weeks but people often utilise BWW at times of further need with a substantial proportion using it for longer periods on a more regular basis. Over that time people with depression and anxiety show clinically important improvement.

The case for online peer support interventions Peer support internet interventions such as BWW take less effort for service users than internet guided cognitive behaviour therapy (CBT) as it allows the user to choose when and how to access it rather than be committed to a pre-defined course of treatment. The overall effectiveness of BWW may be in keeping with the social model of depression and anxiety from which the website was conceived; that the onset of depression or anxiety may be precipitated by insufficient social support during a time of self-perceived threat to a person's well-being from a life event. Conversely, relief from depression or anxiety may be found through increased social support and improved life events and security.

BWW can therefore guide its users towards appropriate psycho-social support as and when they require it, whilst retaining autonomy through making their own decisions about how to use that support.

An important aspect of BWW's public health approach is to reach out to isolated people with poor quality social support and a perceived threat to their wellbeing. It aims to provide a population based service that doesn't require a personal subscription so that the most disadvantaged are able to benefit. Currently BWW has been purchased by the armed forces, some universities and 25% of Clinical Commissioning groups (CCGs) throughout England which provides free access to 98% of users.

However for a wider uptake by commissioners locally and nationally the service must be tested in a randomised controlled trial (RCT) to understand who, when and how BWW is utilised and its' clinical and cost effectiveness, compared to online information alone.

Trial Objectives To use the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation including economics, Maintenance) to explore the efficacy and reach of an internet intervention (online peer support) compared to online information for people with depression and anxiety.

Use qualitative analysis to determine the engagement and experiences of the participants in the BWW arm of the study to understand the motivations for use, patterns and levels of engagement (e.g. active user versus 'lurker'), negative experiences and beliefs about efficacy and role in personal empowerment.

More specifically the trial objectives are:

  1. To determine the short-term clinical effectiveness of Big White Wall (BWW) versus the National Health Service (NHS) Choices Moodzone (MZ) website on well-being (primary outcome).
  2. To determine the number and representativeness of participants invited and eligible to receive BWW or the NHS Choices Moodzone website.
  3. To determine the number, percent and representativeness of NHS primary care practices and organisations, secondary care mental health, community and acute trust, third sector and social care organisations that referred people to either BWW or the NHS Choices Moodzone website
  4. To explore the implementation of the BWW programme including barriers and drivers to reach, effectiveness and adoption and an economic evaluation of its costs and cost effectiveness from personal, social and health care perspectives.
  5. To explore the maintenance of treatment effects on well-being, depressive symptoms, anxiety symptoms, quality of life and social function over 6 months in service users
  6. With Academic Helth Science Network (AHSN) East Midlands to record the take up by organisations and implementation (number, percent, representativeness in East Midlands) of BWW across the East Midlands after the trial has been completed
  7. Explore user engagement and experiences of BWW through qualitative interviews and text analysis

Expected duration in the trial is 6 months.

Implementation A managed network of practice will be established ideally with representation from the mental health leads from Nottingham City and Nottinghamshire CCGs and public health together with the User consultant and a GP Knowledge Broker as well as key members of National Institute of Health Research (NIHR) MindTech and the study team. This network will ensure that both the engagement strategy and the research project itself are optimised and that important learning on implementation is collected. The results of this RE-AIM study will provide a rich database of information to inform CCGs and Health and Wellbeing Boards on who BWW and other digital mental health services might reach Access to BWW across the East Midlands will depend on commissioning decisions at a public health and primary care level. At the end of the study we will work with AHSN East Midlands and Public Health England to present these findings to Directors of Public Health and mental health leads for each CCG or consortium of CCGs, Healthwatch representatives and mental health providers in the East Midlands together with a directory of alternative providers of similar services.

Conditions
Depression, Anxiety
Being tested
BWW Online Peer Support, NHS Moodzone Online Information
Keywords
Stress, Low Mood, Mental Health, Peer Support, Online
Medical subject headings
Depression, Anxiety Disorders, Consciousness Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BWW Online Peer SupportOther

    Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.

  • NHS Moodzone Online InformationOther

    Directed to access to online information from NHS Moodzone

Study groups in NCT02902159
Study groupRoleWhat they receive
BWWExperimentalFree access to online peer support through BWW for 6 months
Receives: Other: BWW Online Peer Support
MZExperimentalAccess to NHS Moodzone Information Only
Receives: Other: NHS Moodzone Online Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Warwick-Edinburgh Mental Well-being Scale - 14 Item

    Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6

    Measured: 6 weeks

Secondary outcomes (8)
  1. Warwick-Edinburgh Mental Well-being Scale - 14 Item

    Maintenance of effect

    Measured: 12 and 26 weeks

  2. Generalised Anxiety Disorder 7 Item Scale (GAD-7)

    Change in score on GAD7 at 6, 12 \& 26 weeks

    Measured: 6, 12 & 26 weeks

  3. Personal Health Questionnaire 9 Item (PHQ-9) 11

    Change in score at 6, 12 \& 26 weeks

    Measured: 6, 12 & 26 weeks

  4. SF-12 v2 Health Survey 12

    Change in score at 6, 12 \& 26 weeks

    Measured: 6, 12 & 26 weeks

  5. Work and Social Adjustment Scale 8 Item - Social Function 13

    Change in score at 6, 12 \& 26 weeks

    Measured: 6, 12 & 26 weeks

  6. 8-item social support measure14

    Change in score at 6, 12 \& 26 weeks

    Measured: 6, 12 & 26 weeks

  7. 12-item Brugha Inventory of Life Events15

    Change in score at 26 weeks

    Measured: 26 weeks

  8. 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS

    Change in score at 6, 12 \& 26 weeks

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902159
Sponsor's protocol ID
CLAHRC-EM 16053
Acronym
REBOOT
Status last verified
Feb 2018
First submitted
12 Sep 2016
Last updated
15 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Crisp D, Griffiths K, Mackinnon A, Bennett K, Christensen H. An online intervention for reducing depressive symptoms: secondary benefits for self-esteem, empowerment and quality of life. Psychiatry Res. 2014 Apr 30;216(1):60-6. doi: 10.1016/j.psychres.2014.01.041. Epub 2014 Feb 3.

    PubMed 24534125
  • Spiers N, Bebbington P, McManus S, Brugha TS, Jenkins R, Meltzer H. Age and birth cohort differences in the prevalence of common mental disorder in England: National Psychiatric Morbidity Surveys 1993-2007. Br J Psychiatry. 2011 Jun;198(6):479-84. doi: 10.1192/bjp.bp.110.084269.

    PubMed 21628710
  • Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.

    PubMed 20967242
  • Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113.

    PubMed 21192795
  • Mojtabai R, Olfson M, Sampson NA, Jin R, Druss B, Wang PS, Wells KB, Pincus HA, Kessler RC. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011 Aug;41(8):1751-61. doi: 10.1017/S0033291710002291. Epub 2010 Dec 7.

    PubMed 21134315
  • Happonen AP, Kaipainen K, Vaatanen A, Kinnunen ML, Myllymaki T, Lappalainen P, Tuomela H, Rusko H, Mattila E, Lappalainen R, Korhonen I. A concept to empower self-management of psychophysiological wellbeing: preliminary user study experiences. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:312-5. doi: 10.1109/IEMBS.2009.5333549.

    PubMed 19964215

Questions about this trial

What is this clinical trial studying?

A study testing BWW Online Peer Support and NHS Moodzone Online Information in people with Depression and Anxiety, run by University of Nottingham at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Catherine J Kaylor-Hughes, DPhil (+441158232478, catherine.kaylor-hughes@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Warwick-Edinburgh Mental Well-being Scale - 14 Item (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02902159, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.

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