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 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

scholarly journals A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Nicolas A. Barticevic ◽  
Fernando Poblete ◽  
Soledad M. Zuzulich ◽  
Victoria Rodriguez ◽  
Diego Quevedo ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Risky Alcohol ◽  
Risky Alcohol Consumption ◽  
Audit Score

Abstract Background Because of the shortage of health professionals in Chilean primary care, Health Technicians (HT) are providing Brief Interventions (BI) for risky alcohol consumption. We compared the efficacy of two AUDIT-linked interventions provided by HTs: an informative leaflet and a BI plus leaflet. Methods This is a parallel-group randomized controlled trial with 1:1 randomization. Participants were identified through screening with the Alcohol Use Disorders Identification Test (AUDIT) at five primary care centers between March 2016 and July 2017. People older than 18 years at intermediate-risk (AUDIT score 8 to 15, inclusive) were randomized to receive either an HT-delivered BI (n = 174) or an informative leaflet (n = 168). Only data from participants (n = 294) who completed the 6-month assessment were analyzed. The leaflet was delivered without further advice. It contains alcohol consumption limits, a change planner, and strategies to decrease drinking. The BI was a 5-min discussion on the leaflet´s content plus normative feedback, tailored information on alcohol and health, and a change plan. The change in the AUDIT risk category six months after randomization (primary outcome) was compared among groups with a Chi-squared test. Changes in the secondary outcomes, which were scores on the AUDIT and the AUDIT´s consumption items (AUDIT-C), were compared with T-tests. Mixed-effects linear models adjusted for potential confounders. Outcome adjudicators were blinded to group assignment. Results At 6-month follow-up, low-risk alcohol consumption was observed in 119 (80%) participants in the BI group, and in 103 (71%) in the leaflet group, with no difference among groups ($$\chi 2$$ χ 2 [1, N = 294] = 2.6, p = 0.1; adjusted odds ratio 0.6; 95% confidence interval [CI] 0.34, 1.05). The mean AUDIT score decreased by 5.76 points in the BI group, and by 5.07 in the leaflet group, which represents a 0.86 AUDIT point reduction attributable to the BI (secondary outcome) (T = 2.03, p = 0.043; adjusted mean difference 0.86 CI 0.06, 1.66). Conclusions The AUDIT-linked BI delivered by HTs was not associated with a greater reduction of risky alcohol consumption than an informative leaflet. Delivering a leaflet could be more efficient than a BI when provided by HTs; however, more research on the effectiveness of the leaflet is needed. Trial registration ClinicalTrials.gov NCT02642757 (December 30, 2015) https://clinicaltrials.gov/ct2/show/NCT02642757.

Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: A double-blind placebo-controlled trial followed by an open-label extension

2013 ◽  
Vol 28 (6) ◽  
pp. 386-391 ◽  
Author(s):  
I. Manor ◽  
A. Magen ◽  
D. Keidar ◽  
S. Rosen ◽  
H. Tasker ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Groups ◽  
Open Label ◽  
Double Blind ◽  
Blood Biochemical ◽  
Study Results ◽  
Open Label Extension ◽  
Safety Parameters

AbstractObjective:To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).Methods:Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.Results:One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.Conclusions:Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

scholarly journals Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial

2018 ◽  
Vol 49 (4) ◽  
pp. 655-663 ◽  
Author(s):  
Fernanda Palhano-Fontes ◽  
Dayanna Barreto ◽  
Heloisa Onias ◽  
Katia C. Andrade ◽  
Morgana M. Novaes ◽  
...  
Keyword(s):  
Rating Scale ◽  
Remission Rate ◽  
Controlled Trial ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Open Label ◽  
Double Blind ◽  
Therapeutic Value ◽  
Antidepressant Effects ◽  
Resistant Depression

AbstractBackgroundRecent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression.MethodsTo test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing.ResultsWe observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p= 0.04), and at D7 (p< 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen'sd= 0.84; D2: Cohen'sd= 0.84; D7: Cohen'sd= 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64%v.27%;p= 0.04). Remission rate showed a trend toward significance at D7 (36%v.7%,p= 0.054).ConclusionsTo our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered athttp://clinicaltrials.gov(NCT02914769).

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Alcohol Use Disorder and Comorbid Depression: A Randomized Controlled Trial Investigating the Effectiveness of Supportive Text Messages in Aiding Recovery

2019 ◽  
Vol 54 (5) ◽  
pp. 551-558 ◽  
Author(s):  
Helen O’Reilly ◽  
Aisling Hagerty ◽  
Seamus O’Donnell ◽  
Aoife Farrell ◽  
Dan Hartnett ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Controlled Trial ◽  
Text Messages ◽  
Comorbid Depression ◽  
Randomized Controlled ◽  
Lower Alcohol ◽  
The Impact

This randomized controlled trial examined the impact of daily supportive text messages over a six-month treatment period on mood and alcohol consumption in individuals with a dual diagnosis of alcohol use disorder (AUD) and depression. Results highlighted mood benefits at 3-month and lower alcohol consumption at 6-month treatment points.

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