scholarly journals Personalized Approach Bias Modification Smartphone App (“SWIPE”) to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study

10.2196/21278 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e21278
Author(s):  
Victoria Manning ◽  
Hugh Piercy ◽  
Joshua Benjamin Bernard Garfield ◽  
Dan Ian Lubman
Keyword(s):  
Alcohol Use ◽  
Controlled Trial ◽  
Trial Registration ◽  
Smartphone App ◽  
Motivation To Change ◽  
Open Label ◽  
Approach Bias ◽  
Personalized Approach ◽  
Clinical Trials Registry ◽  
Bias Modification

Background Alcohol accounts for 5.1% of the global burden of disease and injury, and approximately 1 in 10 people worldwide develop an alcohol use disorder. Approach bias modification (ABM) is a computerized cognitive training intervention in which patients are trained to “avoid” alcohol-related images and “approach” neutral or positive images. ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation). However, many people who drink at hazardous or harmful levels do not require residential treatment or choose not to access it (eg, owing to its cost, duration, inconvenience, or concerns about privacy). Smartphone app–delivered ABM could offer a free, convenient intervention to reduce cravings and consumption that is accessible regardless of time and place, and during periods when support is most needed. Importantly, an ABM app could also easily be personalized (eg, allowing participants to select personally relevant images as training stimuli) and gamified (eg, by rewarding participants for the speed and accuracy of responses) to encourage engagement and training completion. Objective We aim to test the feasibility and acceptability of “SWIPE,” a gamified, personalized alcohol ABM smartphone app, assess its preliminary effectiveness, and explore in which populations the app shows the strongest indicators of effectiveness. Methods We aim to recruit 500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking. Recruitment will be conducted through social media and websites. The participants’ intended alcohol use goal (reduction or abstinence), motivation to change their consumption, and confidence to change their consumption will be measured prior to training. Participants will be instructed to download the SWIPE app and complete at least 2 ABM sessions per week for 4 weeks. Recruitment and completion rates will be used to assess feasibility. Four weeks after downloading SWIPE, participants will be asked to rate SWIPE’s functionality, esthetics, and quality to assess acceptability. Alcohol consumption, craving, and dependence will be measured prior to commencing the first session of ABM and 4 weeks later to assess whether these variables change significantly over the course of ABM. Results We expect to commence recruitment in August 2020 and complete data collection in March 2021. Conclusions This will be the first study to test the feasibility, acceptability, and preliminary effectiveness of a personalized, gamified ABM intervention smartphone app for hazardous or harmful drinkers. Results will inform further improvements to the app, as well as the design of a statistically powered randomized controlled trial to test its efficacy relative to a control condition. Ultimately, we hope that SWIPE will extend the benefits of ABM to the millions of individuals who consume alcohol at hazardous levels and wish to reduce their use but cannot or choose not to access treatment. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p International Registered Report Identifier (IRRID) PRR1-10.2196/21278

scholarly journals Personalized Approach Bias Modification Smartphone App (“SWIPE”) to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study (Preprint)

2020 ◽  
Author(s):  
Victoria Manning ◽  
Hugh Piercy ◽  
Joshua Benjamin Bernard Garfield ◽  
Dan Ian Lubman
Keyword(s):  
Alcohol Use ◽  
Controlled Trial ◽  
Smartphone App ◽  
Motivation To Change ◽  
Open Label ◽  
Approach Bias ◽  
Alcohol Relapse ◽  
Personalized Approach ◽  
Clinical Trials Registry ◽  
Bias Modification

BACKGROUND Alcohol accounts for 5.1% of the global burden of disease and injury, and approximately 1 in 10 people worldwide develop an alcohol use disorder. Approach bias modification (ABM) is a computerized cognitive training intervention in which patients are trained to “avoid” alcohol-related images and “approach” neutral or positive images. ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation). However, many people who drink at hazardous or harmful levels do not require residential treatment or choose not to access it (eg, owing to its cost, duration, inconvenience, or concerns about privacy). Smartphone app–delivered ABM could offer a free, convenient intervention to reduce cravings and consumption that is accessible regardless of time and place, and during periods when support is most needed. Importantly, an ABM app could also easily be personalized (eg, allowing participants to select personally relevant images as training stimuli) and gamified (eg, by rewarding participants for the speed and accuracy of responses) to encourage engagement and training completion. OBJECTIVE We aim to test the feasibility and acceptability of “SWIPE,” a gamified, personalized alcohol ABM smartphone app, assess its preliminary effectiveness, and explore in which populations the app shows the strongest indicators of effectiveness. METHODS We aim to recruit 500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking. Recruitment will be conducted through social media and websites. The participants’ intended alcohol use goal (reduction or abstinence), motivation to change their consumption, and confidence to change their consumption will be measured prior to training. Participants will be instructed to download the SWIPE app and complete at least 2 ABM sessions per week for 4 weeks. Recruitment and completion rates will be used to assess feasibility. Four weeks after downloading SWIPE, participants will be asked to rate SWIPE’s functionality, esthetics, and quality to assess acceptability. Alcohol consumption, craving, and dependence will be measured prior to commencing the first session of ABM and 4 weeks later to assess whether these variables change significantly over the course of ABM. RESULTS We expect to commence recruitment in August 2020 and complete data collection in March 2021. CONCLUSIONS This will be the first study to test the feasibility, acceptability, and preliminary effectiveness of a personalized, gamified ABM intervention smartphone app for hazardous or harmful drinkers. Results will inform further improvements to the app, as well as the design of a statistically powered randomized controlled trial to test its efficacy relative to a control condition. Ultimately, we hope that SWIPE will extend the benefits of ABM to the millions of individuals who consume alcohol at hazardous levels and wish to reduce their use but cannot or choose not to access treatment. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p INTERNATIONAL REGISTERED REPORT PRR1-10.2196/21278

SWiPE: a novel personalised approach bias modification smartphone application to reduce alcohol use among people drinking at hazardous levels: a feasibility, acceptability and preliminary effectiveness study (Preprint)

2021 ◽  
Author(s):  
Victoria Manning ◽  
Hugh Piercy ◽  
Joshua Benjamin Bernard Garfield ◽  
Stuart Gregory Clark ◽  
Mah Noor Andrabi ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Alcohol Use ◽  
Rating Scale ◽  
Controlled Trial ◽  
Cognitive Intervention ◽  
Alcohol Problems ◽  
Open Label ◽  
Approach Bias ◽  
Audit Score ◽  
Bias Modification

BACKGROUND Background: Approach Bias Modification (ApBM), a computerised cognitive intervention which trains people to “avoid” alcohol-related images and “approach” neutral/non-alcohol images, reduces the likelihood of relapse when administered during residential alcohol treatment. However, most individuals experiencing alcohol problems do not require, do not seek, or cannot access residential treatment. Smartphone-delivered ApBM could offer an easily-accessible intervention to reduce alcohol consumption which can be personalised (e.g., allowing selection of personally-relevant alcohol and positive training images) and gamified to optimise engagement. OBJECTIVE Objective: We examined the feasibility, acceptability and preliminary effectiveness of “SWiPE”, a gamified, personalised alcohol ApBM smartphone app, and explored alcohol consumption and craving outcomes, in people drinking at hazardous levels (AUDIT score of 8+) who wanted to reduce their alcohol use. METHODS Methods: We conducted an open-label trial in which frequency and quantity of alcohol consumption, severity of alcohol dependence, and craving were measured prior to participants downloading SWiPE. Participants (n=1309) were instructed to complete at least 2 sessions per week for 4 weeks. Recruitment and completion rates were indicators of feasibility. Functionality, aesthetics, and quality ratings were indicators of acceptability. Participants were prompted to report frequency and quantity of alcohol consumption each week during training, and 1-month after training, and completed measures of craving and dependence after 4-weeks of training. RESULTS Results: We recruited 1309 participants (mean age 47.0 years (SD 10.0); 57.9% female; mean AUDIT score 21.8 (SD 6.5)) over a 6-month period. Participants completed a median of 5 sessions (IQR 2-9), 409 (31.2%) completed at least 8 sessions and 455 (34.8%) completed the post-training survey. Mean Mobile Application Rating Scale scores were 4.4 (SD 0.5) for functionality, 4.2 (SD 0.5) for aesthetics and 3.4 (SD 0.8) for subjective quality. Among those who completed post-training assessment, mean past-week drinking days reduced from 5.1 (SD 2.0) pre-training to 4.2 (SD 2.3) in week 4 (t454=7.87; P<.001). Mean past-week standard drinks reduced from 32.8 (SD 22.1) to 24.7 (SD 20.1; t454=8.58; P<.001). Mean Craving Experience Questionnaire frequency scores reduced from 4.5 (SD 2.0) to 2.8 (SD 1.8; t435=19.39; P<.001). Severity of Dependence scores reduced from 7.7 (SD 3.0) to 6.0 (SD 3.2; t435=12.44; P<.001). In the 254 (19.4%) participants who completed a 1-month follow-up, mean past-week drinking days was 3.9 (SD 2.5) and mean standard drinks was 23.9 (SD 20.7), both significantly lower than at baseline (P<0.001). CONCLUSIONS Conclusion: The findings suggest SWiPE is feasible, acceptable and may be effective at reducing alcohol consumption and craving in a predominantly non-treatment seeking sample of adult Australians drinking at hazardous levels. SWiPE’s efficacy, relative to a control condition, now needs establishing in a randomised controlled trial. Smartphone-delivered personalised ApBM has the potential to be a highly scalable, widely-accessible support tool for reducing alcohol use.

scholarly journals Protocol for the methamphetamine approach-avoidance training (MAAT) trial, a randomised controlled trial of personalised approach bias modification for methamphetamine use disorder

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Joshua B. B. Garfield ◽  
Hugh Piercy ◽  
Shalini Arunogiri ◽  
Dan I. Lubman ◽  
Samuel C. Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Registration ◽  
Approach Bias ◽  
Methamphetamine Use ◽  
Randomised Controlled ◽  
Methamphetamine Use Disorder ◽  
Residential Rehabilitation ◽  
Bias Modification ◽  
Relapse Rates

Abstract Background Globally, methamphetamine use has increased in prevalence in recent years. In Australia, there has been a dramatic increase in numbers of people seeking treatment, including residential rehabilitation, for methamphetamine use disorder (MUD). While residential rehabilitation is more effective for MUD than withdrawal treatment (i.e. “detoxification”) alone, relapse rates remain high, with approximately half of rehabilitation clients using methamphetamine within 3 months of rehabilitation. “Approach bias modification” (ABM) is a computerised cognitive training approach that aims to dampen automatically triggered impulses to approach drugs and drug-related stimuli. ABM has been demonstrated to reduce alcohol relapse rates, but no randomised controlled trials of ABM for MUD have yet been conducted. We aim to test whether a novel “personalised” form of ABM, delivered during rehabilitation, reduces post-treatment methamphetamine use, relative to a sham-training control condition. Secondary outcomes will include dependence symptoms, cravings, and approach bias. Methods We aim to recruit 100 participants attending residential rehabilitation for MUD at 3 sites in the Melbourne metropolitan area. Participants will complete baseline measures of methamphetamine use, craving, dependence severity, and approach bias before being randomised to receiving 6 sessions of ABM or “sham” training. In the active condition, ABM will be personalised for each participant, using those methamphetamine images that they rate as most relevant to their recent methods of methamphetamine use as “avoidance” images and using positive images representing their goals or healthy sources of pleasure as “approach” images. Approach bias and craving will be re-assessed following completion of training, and methamphetamine use, dependence, and craving will be assessed 4 weeks and 3 months following discharge from residential treatment. Discussion This study is the first randomised controlled trial of ABM for MUD and also the first ABM study to test using a personalised set of both approach and avoid images for ABM training. If effective, the low cost and easy implementation of ABM means it could be widely implemented as a standard part of MUD treatment. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620000072910. Registered on 30 January 2020 (prospectively registered): https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378804&isReview=true

scholarly journals A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Yingcai Zhang ◽  
Jiebin Zhang ◽  
Huimin Yi ◽  
Jun Zheng ◽  
Jianye Cai ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Hepatic Failure ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Trial Registration ◽  
Biliary Complications ◽  
Open Label ◽  
Antibody Mediated Rejection ◽  
Link Type ◽  
Induction Strategy

Abstract Background ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. Methods Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. Results No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). Conclusions Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. Trial registration Trial registration: chictr.org.cn, ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074.

scholarly journals Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Otitis Media ◽  
Conjugate Vaccine ◽  
Otitis Media With Effusion ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Open Label ◽  
Suppurative Otitis Media ◽  
Link Type

Abstract Background Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Methods In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM). Results Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM. Conclusions Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life. Trial registration ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.

A 6-Month Randomized Trial of a Smartphone Application, UControlDrink, in Aiding Recovery in Alcohol Use Disorder

2021 ◽  
pp. 1-12
Author(s):  
Conor Farren ◽  
Aoife Farrell ◽  
Aisling Hagerty ◽  
Cliodhna McHugh
Keyword(s):  
Alcohol Use ◽  
Text Messaging ◽  
Alcohol Use Disorder ◽  
Positive Impact ◽  
Controlled Trial ◽  
Intervention Group ◽  
Heavy Drinking ◽  
Smartphone Application ◽  
Smartphone App ◽  
Control Group

<b><i>Background and Aims:</i></b> Alcohol use disorder (AUD) is a substantial problem, causing early death and great economic burden. Research has highlighted the potential positive impact of technological interventions, such as smartphone applications (app) in treatment of AUD. The aim of this study was to explore the effectiveness of a smartphone app, incorporating computerized cognitive behavioural therapy and text messaging support, on alcohol outcomes over 6 months in a post-rehabilitation setting. <b><i>Methods:</i></b> A total of 111 participants with AUD were recruited into this randomized controlled trial, following completion of a 30-day rehabilitation programme. The intervention group (<i>n</i> = 54) used the smartphone app “UControlDrink” (UCD) over 6 months with treatment as usual (TAU), and the control group (<i>n</i> = 57) received TAU. All subjects suffered from AUD as the primary disorder, with other major psychiatric disorders excluded. All intervention subjects used the UCD smartphone app in the treatment trial, and all subjects underwent TAU consisting of outpatient weekly support groups. Drinking history in the previous 90 days was measured at baseline and at 3- and 6-month follow-ups. Additional measurements were made to assess mood, anxiety, craving, and motivation. Results were analysed using intention-to-treat analyses. <b><i>Results:</i></b> Retention in the study was 72% at 3 months and 52% at 6 months. There was a significant reduction in heavy drinking days in the intervention group relative to TAU over the 6 months, <i>p</i> &#x3c; 0.02. <b><i>Conclusions:</i></b> The UCD smartphone app demonstrates a significant benefit to reducing heavy drinking days over a 6-month post-rehabilitation period in AUD.

scholarly journals N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lauren Arancini ◽  
Chiara C. Bortolasci ◽  
Seetal Dodd ◽  
Olivia M. Dean ◽  
Michael Berk
Keyword(s):  
Public Health ◽  
Tobacco Smoking ◽  
Rating Scales ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Trial Registration ◽  
Diagnostic Statistics ◽  
Salivary Cotinine ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Abstract Background Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a rationale and protocol for the trial of N-acetylcysteine (NAC) as a novel anti-craving smoking cessation aid. Methods Current smokers (n = 120) of at least 10 cigarettes a day are recruited through online advertisements, print publications and dissemination of flyers. Participants are randomised on a 1:1 ratio to receive either 16-week treatment of 1.8 g/day of NAC or placebo with all participants receiving quit support from the online QuitCoach tool. Participants are attending visits at baseline, 8 and 16 weeks with a 42-week post-discontinuation follow-up. The primary outcome measure is sustained abstinence at six months after treatment based on self-reported rating scales and confirmed by exhaled carbon monoxide and salivary cotinine levels. Secondary outcomes are timing of the first lapse and relapse, between-group cigarette consumption, withdrawal symptoms, general wellbeing and mood/anxiety symptoms. Between-group differences in adverse events and subgroup analyses for variables including gender and Diagnostic Statistics Manual 5 diagnostics will also be investigated. Discussion The planned trial addresses an issue of major importance to human health and, if an effect is shown, may result in substantial changes to the management of smoking and nicotine addiction with overt public health implications. Trial registration Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12617001478303. Registered on 19 October 2017.

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