Outcomes of a public health campaign and automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study). (Preprint)

2020 ◽  
Author(s):  
Richard Morriss ◽  
Catherine Kaylor-Hughes ◽  
Matthew Rawsthorne ◽  
Neil Coulson ◽  
Sandra Simpson ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Health Services ◽  
Peer Support ◽  
Controlled Trial ◽  
Depression And Anxiety ◽  
The Public ◽  
Moderate Depression ◽  
White Wall ◽  
Randomised Controlled

BACKGROUND Effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe public health online services delivered directly to the public. One model is Big White Wall, which offers peer support at low cost. Since these interventions are delivered digitally, we tested whether a randomised controlled trial (RCT) intervention could also be fully delivered and evaluated digitally. OBJECTIVE To determine the reach, feasibility, acceptability, baseline costs and outcomes of a public health campaign for an automated randomised controlled trial of Big White Wall (BWW) providing digital peer support and information, compared with a standard website used by the National Health Service (NHS Choices Moodzone, MZ) in people with probable mild to moderate depression and anxiety disorder. The primary outcome was change in self-rated well-being at 6 weeks, measured by the Warwick-Edinburgh Mental Well-Being Scale. METHODS An 18 month campaign was performed across Nottinghamshire, United Kingdom (target population 914,000) to advertise the trial direct to the public through general marketing, online and social media sources, health services, other public services and third sector groups. The population reach of this campaign was examined by numbers accessing the study website and self-registering to the study. A pragmatic, parallel group, single blind RCT (ISRCTN ) was then conducted using a fully automated trial website in which eligible participants were randomised to receive either 6 months access to BWW or signposted to MZ. Those eligible for participation were over 16 years with probable mild to moderate depression or anxiety disorders. RESULTS Of 6483 visitors to the study website, only 1,510 were eligible. 790 (52.3% of eligible) participated, 397 randomised to BWW and 393 to MZ. Their mean age (sd) was 38.0 (13.8) years, 640 (82.0%) were female, 738 (93.7%) were white, all had educational qualifications, and 271 (47.4%) had no contact with health services in the previous three months. We estimated 3-month productivity losses of £1019.05 (1057.70) per person for those employed. Only 131 (16.6%) participants completed the primary outcome assessment. There were no differences in primary nor secondary outcomes between the two groups. CONCLUSIONS Most participants reached and eligible for this trial of digital intervention providing information and/or support for mild to moderate depression and anxiety were educated women of white ethnicity not in recent contact with health services, and whose productivity losses represent a significant annual societal burden A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428. INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8061

scholarly journals Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Catherine J Kaylor-Hughes ◽  
Mat Rawsthorne ◽  
Neil S Coulson ◽  
Sandra Simpson ◽  
Lucy Simons ◽  
...  
Keyword(s):  
Public Health ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Peer Support ◽  
Controlled Trial ◽  
Care Staff ◽  
Depression And Anxiety ◽  
Web Based ◽  
Randomized Controlled ◽  
Moderate Depression

BACKGROUND Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health–driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. OBJECTIVE Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK’s National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. METHODS A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. RESULTS The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. CONCLUSIONS This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a)

scholarly journals Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

BMJ ◽  
2015 ◽  
pp. h6127 ◽  
Author(s):  
Hilde P A van der Aa ◽  
Ger H M B van Rens ◽  
Hannie C Comijs ◽  
Tom H Margrain ◽  
Francisca Gallindo-Garre ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Visually Impaired ◽  
Controlled Trial ◽  
Stepped Care ◽  
Depression And Anxiety ◽  
Randomised Controlled

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Incentives in Diabetic Eye Assessment by Screening (IDEAS) trial: a three-armed randomised controlled trial of financial incentives

2017 ◽  
Vol 5 (15) ◽  
pp. 1-60 ◽  
Author(s):  
Gaby Judah ◽  
Ara Darzi ◽  
Ivo Vlaev ◽  
Laura Gunn ◽  
Derek King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Services ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Fixed Group ◽  
Screening Uptake ◽  
Invitation Letter ◽  
Screening Attendance ◽  
Randomised Controlled

BackgroundThe UK national diabetic eye screening (DES) programme invites diabetic patients aged > 12 years annually. Simple and cost-effective methods are needed to increase screening uptake. This trial tests the impact on uptake of two financial incentive schemes, based on behavioural economic principles.ObjectivesTo test whether or not financial incentives encourage screening attendance. Secondarily to understand if the type of financial incentive scheme used affects screening uptake or attracts patients with a different sociodemographic status to regular attenders. If financial incentives were found to improve attendance, then a final objective was to test cost-effectiveness.DesignThree-armed randomised controlled trial.SettingDES clinic within St Mary’s Hospital, London, covering patients from the areas of Kensington, Chelsea and Westminster.ParticipantsPatients aged ≥ 16 years, who had not attended their DES appointment for ≥ 2 years.Interventions(1) Fixed incentive – invitation letter and £10 for attending screening; (2) probabilistic (lottery) incentive – invitation letter and 1% chance of winning £1000 for attending screening; and (3) control – invitation letter only.Main outcome measuresThe primary outcome was screening attendance. Rates for control versus fixed and lottery incentive groups were compared using relative risk (RR) and risk difference with corresponding 95% confidence intervals (CIs).ResultsA total of 1274 patients were eligible and randomised; 223 patients became ineligible before invite and 1051 participants were invited (control,n = 435; fixed group,n = 312; lottery group,n = 304). Thirty-four (7.8%, 95% CI 5.29% to 10.34%) control, 17 (5.5%, 95% CI 2.93% to 7.97%) fixed group and 10 (3.3%, 95% CI 1.28% to 5.29%) lottery group participants attended. Participants offered incentives were 44% less likely to attend screening than controls (RR 0.56, 95% CI 0.34 to 0.92). Examining incentive groups separately, the lottery group were 58% less likely to attend screening than controls (RR 0.42, 95% CI 0.18 to 0.98). No significant differences were found between fixed incentive and control groups (RR 0.70, 95% CI 0.35 to 1.39) or between fixed and lottery incentive groups (RR 1.66, 95% CI 0.65 to 4.21). Subgroup analyses showed no significant associations between attendance and sociodemographic factors, including gender (female vs. male, RR 1.25, 95% CI 0.77 to 2.03), age (≤ 65 years vs. > 65 years, RR 1.26, 95% CI 0.77 to 2.08), deprivation [0–20 Index of Multiple Deprivation (IMD) decile vs. 30–100 IMD decile, RR 1.12, 95% CI 0.69 to 1.83], years registered [mean difference (MD) –0.13, 95% CI –0.69 to 0.43], and distance from screening location (MD –0.18, 95% CI –0.65 to 0.29).LimitationsDespite verification, some address details may have been outdated, and high ethnic diversity may have resulted in language barriers for participants.ConclusionsThose receiving incentives were not more likely to attend a DES than those receiving a usual invitation letter in patients who are regular non-attenders. Both fixed and lottery incentives appeared to reduce attendance. Overall, there is no evidence to support the use of financial incentives to promote diabetic retinopathy screening. Testing interventions in context, even if they appear to be supported by theory, is important.Future workFuture research, specifically in this area, should focus on identifying barriers to screening and other non-financial methods to overcome them.Trial registrationCurrent Controlled Trials ISRCTN14896403.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 5, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Breastfeeding peer support by telephone in the RUBY randomised controlled trial: A qualitative exploration of volunteers’ experiences

PLoS ONE ◽  
2020 ◽  
Vol 15 (8) ◽  
pp. e0237190 ◽  
Author(s):  
Heather A. Grimes ◽  
Della A. Forster ◽  
Touran Shafiei ◽  
Lisa H. Amir ◽  
Fiona McLardie-Hore ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
Qualitative Exploration

scholarly journals Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027952 ◽  
Author(s):  
Siobhan O'Higgins ◽  
Jennifer Stinson ◽  
Sara Ahola Kohut ◽  
Line Caes ◽  
Caroline Heary ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Qualitative Content Analysis ◽  
Controlled Trial ◽  
Self Management ◽  
Advisory Panel ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Taking Charge ◽  
Randomised Controlled

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.

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