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

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ClinicalTrials.gov Identifier: NCT02902159
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date February 15, 2018
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
Warwick-Edinburgh Mental Well-being Scale - 14 Item [ Time Frame: 6 weeks ]
Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02902159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
  • Warwick-Edinburgh Mental Well-being Scale - 14 Item [ Time Frame: 12 and 26 weeks ]
    Maintenance of effect
  • Generalised Anxiety Disorder 7 Item Scale (GAD-7) [ Time Frame: 6, 12 & 26 weeks ]
    Change in score on GAD7 at 6, 12 & 26 weeks
  • Personal Health Questionnaire 9 Item (PHQ-9) 11 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks
  • SF-12 v2 Health Survey 12 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks
  • Work and Social Adjustment Scale 8 Item - Social Function 13 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks
  • 8-item social support measure14 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks
  • 12-item Brugha Inventory of Life Events15 [ Time Frame: 26 weeks ]
    Change in score at 26 weeks
  • 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS [ Time Frame: 26 weeks ]
    Change in score at 6, 12 & 26 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2016)
Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline, 6, 12 & 26 weeks ]
Health Economics Measure
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE RCT of the Effectiveness of Big White Wall Compared to Other Online Support
Official Title  ICMJE 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.
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Depression
  • Anxiety
Intervention  ICMJE
  • Other: BWW Online Peer Support
    Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.
  • Other: NHS Moodzone Online Information
    Directed to access to online information from NHS Moodzone
Study Arms  ICMJE
  • Experimental: BWW
    Free access to online peer support through BWW for 6 months
    Intervention: Other: BWW Online Peer Support
  • Experimental: MZ
    Access to NHS Moodzone Information Only
    Intervention: Other: NHS Moodzone Online Information
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2016)
2200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine J Kaylor-Hughes, DPhil +441158232478 catherine.kaylor-hughes@nottingham.ac.uk
Contact: Mat Rawsthorne, BSc +44115 8232478 mat.rawsthorne@nottingham.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02902159
Other Study ID Numbers  ICMJE CLAHRC-EM 16053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Morriss, MD CLAHRC-EM
PRS Account University of Nottingham
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP