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

14. února 2018 aktualizováno: University of Nottingham

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

2200

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Nottinghamshire
      • Nottingham, Nottinghamshire, Spojené království, NG7 2UH
        • Nábor
        • Nottingham University Hospitals NHS Trust
      • Nottingham, Nottinghamshire, Spojené království, NG3 6AA
        • Nábor
        • Nottinghamshire Healthcare NHS foundation Trust.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

16 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: BWW
Free access to online peer support through BWW for 6 months
Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.
Experimentální: MZ
Access to NHS Moodzone Information Only
Directed to access to online information from NHS Moodzone

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Warwick-Edinburgh Mental Well-being Scale - 14 Item
Časové okno: 6 weeks
Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6
6 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Warwick-Edinburgh Mental Well-being Scale - 14 Item
Časové okno: 12 and 26 weeks
Maintenance of effect
12 and 26 weeks
Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Časové okno: 6, 12 & 26 weeks
Change in score on GAD7 at 6, 12 & 26 weeks
6, 12 & 26 weeks
Personal Health Questionnaire 9 Item (PHQ-9) 11
Časové okno: 6, 12 & 26 weeks
Change in score at 6, 12 & 26 weeks
6, 12 & 26 weeks
SF-12 v2 Health Survey 12
Časové okno: 6, 12 & 26 weeks
Change in score at 6, 12 & 26 weeks
6, 12 & 26 weeks
Work and Social Adjustment Scale 8 Item - Social Function 13
Časové okno: 6, 12 & 26 weeks
Change in score at 6, 12 & 26 weeks
6, 12 & 26 weeks
8-item social support measure14
Časové okno: 6, 12 & 26 weeks
Change in score at 6, 12 & 26 weeks
6, 12 & 26 weeks
12-item Brugha Inventory of Life Events15
Časové okno: 26 weeks
Change in score at 26 weeks
26 weeks
8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS
Časové okno: 26 weeks
Change in score at 6, 12 & 26 weeks
26 weeks

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Client Service Receipt Inventory (CSRI)
Časové okno: Baseline, 6, 12 & 26 weeks
Health Economics Measure
Baseline, 6, 12 & 26 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Richard Morriss, MD, CLAHRC-EM

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2016

Primární dokončení (Očekávaný)

1. června 2018

Dokončení studie (Očekávaný)

1. prosince 2018

Termíny zápisu do studia

První předloženo

12. září 2016

První předloženo, které splnilo kritéria kontroly kvality

12. září 2016

První zveřejněno (Odhad)

15. září 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. února 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. února 2018

Naposledy ověřeno

1. února 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CLAHRC-EM 16053

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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