A Personalized Approach Bias Modification Smartphone App ("SWiPE") to Reduce Alcohol Use: Open-Label Feasibility, Acceptability, and Preliminary Effectiveness Study.

Approach bias modification (ApBM), a computerized cognitive intervention that trains people to "avoid" alcohol-related images and "approach" nonalcohol 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 have difficulty accessing residential treatment. Smartphone-delivered ApBM could offer an easily accessible intervention to reduce alcohol consumption that can be personalized (eg, allowing selection of personally relevant alcohol and positive nonalcohol training images) and gamified to optimize engagement. We examined the feasibility, acceptability, and preliminary effectiveness of "SWiPE," a gamified, personalized alcohol ApBM smartphone app, and explored alcohol consumption and craving outcomes in people drinking at hazardous levels or above (Alcohol Use Disorders Identification Test [AUDIT] score ≥8) who wanted to reduce their alcohol use. In this open-label trial, frequency and quantity of alcohol consumption, alcohol dependence severity, 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 weekly during training and 1 month after training. They completed measures of craving and dependence after 4 weeks of training. We recruited 1309 participants (mean age 47.0, SD 10.0 years; 758/1309, 57.9% female; mean AUDIT score 21.8, SD 6.5) over 6 months. Participants completed a median of 5 sessions (IQR 2-9); 31.2% (409/1309) completed ≥8 sessions; and 34.8% (455/1309) completed the posttraining survey. Mean Mobile Application Rating Scale scores indicated good acceptability for functionality and aesthetics and fair acceptability for subjective quality. Among those who completed the posttraining 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), and 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). For the 19.4% (254/1309) of participants who completed a 1-month follow-up, mean past-week drinking days and standard drinks were 3.9 (SD 2.5) and 23.9 (SD 20.7), respectively, both significantly lower than at baseline (P<.001). The findings suggest SWiPE is feasible and acceptable and may be effective at reducing alcohol consumption and craving in a predominantly nontreatment-seeking sample of adult Australians drinking at hazardous levels. SWiPE's efficacy, relative to a control condition, now needs establishing in a randomized controlled trial. Smartphone-delivered personalized ApBM could be a highly scalable, widely accessible support tool for reducing alcohol use. Australian New Zealand Clinical Trials Registry ACTRN12620000638932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p. RR2-10.2196/21278.

Manning V ，Piercy H ，Garfield JBB ，Clark SG ，Andrabi MN ，Lubman DI ... -  《JMIR mHealth and uHealth》

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.

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. 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. 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. We expect to commence recruitment in August 2020 and complete data collection in March 2021. 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. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p. PRR1-10.2196/21278.

Manning V ，Piercy H ，Garfield JBB ，Lubman DI ... -  《-》

Smartphone-delivered approach bias modification for reducing harmful drinking amongst middle-older age adults: Secondary analyses of a single-arm pilot study.

Novel, scalable, low-cost interventions are needed to reduce harmful drinking amongst middle-older adults. Approach bias modification (ApBM) is a promising form of cognitive training for preventing/reducing alcohol use that can be delivered via smartphone. This study explored the acceptability and preliminary effectiveness of smartphone delivered and personalised ApBM amongst Australians ≥55 years, an age cohort at risk of alcohol-related harms. Secondary analyses in a middle-older adult subsample (≥55 years, n = 289) of an open-label pilot study using a retrospective, repeated measures design. We explored acceptability (adherence, user mobile acceptability ratings, free-text responses) and preliminary effectiveness (changes in drinking quantity and frequency, craving, dependence and proportion drinking within government-recommended guidelines) of two sessions/week over 4 weeks of evidence-based ApBM training, adapted to include personalisation and smartphone delivery amongst Australians ≥55 years. Although minor adaptations to training were suggested, the intervention was acceptable amongst survey completers, with 72% training adherence. Relative to baseline, there was a significant increase in the proportion of drinking within recommended single-session and weekly guidelines post-training (from 25% to 41% and 6% to 28%, respectively, p < 0.001), with past-week standard drinks significantly decreasing by 18% (p < 0.001) and significant reductions in drinking days, mean craving and dependence scores (p < 0.001). Findings suggest smartphone ApBM is acceptable amongst middle-to-older aged Australians and may support this 'at risk' cohort to remain within government-recommended alcohol consumption guidelines to optimise healthy aging, although, in the context of a single-arm study, preliminary results should be interpreted cautiously.

Bolt GL ，Piercy H ，Bradshaw J ，Manning V ... -  《-》

A Web-Based Cognitive Bias Modification Intervention (Re-train Your Brain) for Emerging Adults With Co-occurring Social Anxiety and Hazardous Alcohol Use: Protocol for a Multiarm Randomized Controlled Pilot Trial.

Alcohol use and anxiety disorders commonly co-occur, resulting in a more severe clinical presentation and poorer response to treatment. Research has shown that approach bias modification (ApBM) and interpretation bias modification (IBM) cognitive retraining interventions can be efficacious adjunctive treatments that improve outcomes for alcohol use and social anxiety, respectively. However, the acceptability, feasibility, and clinical utility of combining ApBM and IBM programs to optimize treatments among comorbid samples are unknown. It is also unclear whether integrating ApBM and IBM within each training session or alternating them between each session is more acceptable and efficacious. This paper describes the protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the Re-train Your Brain intervention-an adjunct web-based ApBM+IBM program-among a clinical sample of emerging adults with hazardous alcohol use and social anxiety. The study involves a three-arm randomized controlled pilot trial in which treatment-seeking emerging adults (18-30 years) with co-occurring hazardous alcohol use and social anxiety will be individually randomized to receive the Re-train Your Brain integrated program, delivered with 10 biweekly sessions focusing on both social anxiety and alcohol each week, plus treatment as usual (TAU; ie, the model of care provided in accordance with standard practice at their service; n=30); the Re-train Your Brain alternating program, delivered with 10 biweekly sessions focusing on social anxiety one week and alcohol the next week, plus TAU (n=30); or TAU only (n=30). Primary outcomes include feasibility (uptake, follow-up rates, treatment adherence, attrition, and adverse events) and acceptability (system usability, client satisfaction, user experience, and training format preference). Secondary efficacy outcomes include changes in alcohol approach and interpretation biases, social anxiety, and alcohol use (eg, drinks per day, binge drinking, drinking motives, severity of dependence, and cravings). The primary end point will be posttreatment (6 weeks postbaseline), with a secondary end point at 3 months postbaseline. Descriptive statistics will be conducted for primary outcomes, whereas intention-to-treat, multilevel mixed effects analysis for repeated measures will be performed for secondary outcomes. This study is funded from 2019 to 2023 by Australian Rotary Health. Recruitment is expected to be completed by mid-2022 to late 2022, with follow-ups completed by early 2023. This study will be the first to evaluate whether an ApBM+IBM program is acceptable to treatment-seeking, emerging adults and whether it can be feasibly delivered via the web, in settings where it will ultimately be used (eg, at home). The findings will broaden our understanding of the types of programs that emerging adults will engage with and whether the program may be an efficacious treatment option for this comorbidity. Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131. PRR1-10.2196/28667.

Prior K ，Salemink E ，Wiers RW ，Teachman BA ，Piggott M ，Newton NC ，Teesson M ，Baillie AJ ，Manning V ，McLellan LF ，Mahoney A ，Stapinski LA ... -  《-》

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial.

Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support. This study aimed to examine the feasibility, acceptability, and preliminary clinical effect of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavioral therapy (CBT) supported by brief teletherapy appointments with a therapist. This 8-week, single-arm open trial tested the Mindset for Depression app when combined with 8 brief (16-25 minutes) video conferencing visits with a licensed doctoral-level CBT therapist (n=28 participants). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients as well as clinician guidance to promote sustained engagement, monitor safety, and tailor treatment to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted remotely. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale, administered at pretreatment, midpoint, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected. Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high, and attrition was low (n=2, 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (IQR 30-60; week 4) or 60 (IQR 30-90; week 8) minutes per week; participants accessed the app on an average 36.8 (SD 10.0) days and completed a median of 7 of 8 (IQR 6-8) steps by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants' depression severity scores decreased from an average Hamilton Depression Rating Scale score indicating moderate depression (mean 19.1, SD 5.0) at baseline to a week 8 mean score indicating mild depression (mean 10.8, SD 6.1; d=1.47; P<.001). Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up. The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with major depressive disorder. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. The next steps include testing Mindset for Depression in a fully powered randomized controlled trial and real-world clinical settings. ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329.

Wilhelm S ，Bernstein EE ，Bentley KH ，Snorrason I ，Hoeppner SS ，Klare D ，Greenberg JL ，Weingarden H ，McCoy TH ，Harrison O ... -  《JMIR Mental Health》