Depression Clinical Trial
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.
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.
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