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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Nottingham
- Enrollment
- 2,200
- Locations
- 2
- Primary Endpoint
- Warwick-Edinburgh Mental Well-being Scale - 14 Item
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Arms & Interventions
BWW
Free access to online peer support through BWW for 6 months
Intervention: BWW Online Peer Support (Other)
MZ
Access to NHS Moodzone Information Only
Intervention: NHS Moodzone Online Information (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- SF-12 v2 Health Survey 12(6, 12 & 26 weeks)
- Work and Social Adjustment Scale 8 Item - Social Function 13(6, 12 & 26 weeks)
- Warwick-Edinburgh Mental Well-being Scale - 14 Item(12 and 26 weeks)
- Generalised Anxiety Disorder 7 Item Scale (GAD-7)(6, 12 & 26 weeks)
- Personal Health Questionnaire 9 Item (PHQ-9) 11(6, 12 & 26 weeks)
- 8-item social support measure14(6, 12 & 26 weeks)
- 12-item Brugha Inventory of Life Events15(26 weeks)
- 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS(26 weeks)