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

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

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.

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 Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1827
Author(s):  
Nicharat Sawangroj ◽  
Jiratha Budkaew ◽  
Bandit Chumworathayi
Keyword(s):  
Randomized Controlled Trial ◽  
Distress Syndrome ◽  
Curcuma Longa ◽  
Controlled Trial ◽  
Symptom Scale ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Postprandial Distress Syndrome ◽  
Clinical Trials Registry

Background: Proton pump inhibitors are effective for functional dyspepsia but ineffective in relieving postprandial distress syndrome. Curcuma longa might be effective for postprandial distress syndrome. The objective of this study was to compare the efficacy of Curcuma longa and simethicone for postprandial distress syndrome in an open-label randomized-controlled trial. Methods: This trial was conducted between July 2018 and February 2019. In total, 78 patients were randomly assigned to receive 4 weeks of treatment with 750 or 1,500 mg oral Curcuma longa per day or 240 mg simethicone per day. The patients assessed their symptoms using the dyspepsia Global Overall Symptom scale at baseline, week 2, and week 4. After stopping medication for 2 weeks, the patients assessed recurrent symptoms and day of recurrence by themselves at the end of week 6. Results: In total, 78 patients underwent randomization (27 in 750 mg Curcuma longa, 26 in 1500 mg Curcuma longa, and 25 in simethicone groups). After 2 weeks, there were no significant differences in all mean changes of symptoms scores (95%CI) of postprandial distress syndrome [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, the reduction in mean scores was greater among participants receiving simethicone (although not statistically significant) compared with two intervention groups [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122]. The rate of recurrence was significantly lower in simethicone than the two Curcuma longa groups (42.9 vs 45.5 vs 13.6%, P=0.047). There was no serious adverse event reported in all three groups. Conclusions: Curcuma longa had a similar effect on treatment outcomes to simethicone after 2 and 4 weeks, but the recurrence rate of symptoms was significantly higher without serious adverse events. Registration: Registered with the Thai Clinical Trials Registry on 31 January 2018; TCTR20180131001.

scholarly journals An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Eric P. F. Chow ◽  
Kate Maddaford ◽  
Jane S. Hocking ◽  
Catriona S. Bradshaw ◽  
Rebecca Wigan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Health Centre ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled ◽  
New Treatments ◽  
Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

scholarly journals An open label comparison of efficacy of low dose topiramate with naltrexone in preventing alcohol relapse

2017 ◽  
Vol 4 (1) ◽  
pp. 20-26
Author(s):  
K. Marahatta ◽  
J. Ma ◽  
P.M.S. Pradhan ◽  
M. Chapagain ◽  
P Tulachan ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Alcohol Intake ◽  
Low Dose ◽  
Open Label ◽  
Alcohol Relapse ◽  
Daily Alcohol Intake ◽  
Alcohol Detoxification ◽  
Abstinence Period ◽  
Better Than

Introduction: Alcohol use disorder is a relapsing and remitting disorder. Preventing alcohol relapses has been a difficult task. The available drugs do not have adequate outcome in diverse needs. Topiramate, a GABAergic anticonvulsant, has been useful for the prevention of alcohol relapse as demonstrated in western studies. We compared the efficacy of Topiramate at 100mg with Naltrexone 50 mg in preventing relapse among Nepalese alcohol dependence patients.Methods: Following an inpatient alcohol detoxification, 37 patients taking Topiramate 100 mg and 41 patients taking Naltrexone 50 mg were followed up as outpatients at 1, 4, 8 and 12 weeks in order to monitor their abstinence period, craving for alcohol and alcohol use pattern.Results: At the end of 12 weeks follow up, Topiramate is as good as Naltrexone 50 mg in terms of maintaining abstinence (27% vs 31.7%, p=0.651) and reducing the daily alcohol intake. Topiramate is better than Naltrexone in decreasing craving at 12 wks (p=0.015).Conclusion: Topiramate 100 mg is equally efficacious to Naltrexone 50 mg in reducing alcohol craving and maintaining abstinence.

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