Reducing problematic pornography use with imaginal retraining-A randomized controlled trial.

Background and aim: Problematic pornography use (PPU) can be a manifestation of compulsive sexual behavior disorder (CSBD). Studies investigating PPU confirm approach-avoidance tendencies in response to pornographic stimuli in this population. This study show indications of the significance of the efficacy of imaginal retraining, a variant of approach bias modification, as an intervention for PPU. Methods: A total of 274 participants (86.5% male; mean age = 30.65, SD = 10.13) with self-reported PPU were randomized to imaginal retraining (instruction video) or a waitlist control group. Assessments were conducted online at baseline and after the six-week intervention period. The primary outcome was a reduction in problematic pornography use. Compulsive sexual behavior, sexual desire, depressiveness, and satisfaction with the intervention served as secondary outcomes. Results: Retention was low (51.7%), but comparable between groups. The retraining was performed at least once a week (the per-protocol [PP] criterion) by 51.4% of participants. The PP analyses of 111 participants showed a significant reduction in problematic pornography use (primary outcome) in the intervention compared to the control group. The intention-to-treat analyses (ITT), however, did not corroborate this result. Despite low adherence, participants rated their satisfaction with the intervention positively. Discussion and Conclusion: Imaginal retraining can function as a low-threshold self-help intervention for PPU to overcome help-seeking barriers and may reduce PPU in a subgroup of users. Low adherence limits the results of this trial. Given the need for low-threshold interventions for PPU and/or CSBD, further research should focus on increasing adherence and should evaluate retraining for clinical groups. Modifications to augment efficacy are suggested.

How We Lost 90% of Participants on a Bad Bet: Results from a Pilot Randomized Controlled Trial on Cognitive Bias Modification in Problem Gamblers.

Whilst opportunities to participate in gambling have increased, access to support for problem gamblers is lacking behind. This lack of balance calls for improved and accessible intervention methods. The present double-blind randomized controlled trial (RCT) explored the effectiveness of two interventions targeting automatic cognitive processes, known as Attentional Bias Modification (AtBM) and Approach Bias Modification (ApBM). It was hypothesized these interventions would reduce gambling behavior and reduce or reverse targeted biases. Participants (N = 331) were community-recruited Flemish (35%) and Dutch (65%) adult problem gamblers motivated to reduce or stop their gambling who received either six sessions of active training (AtBM or ApBM) or of the corresponding sham-training (sham-AtBM or sham-ApBM). Due to high attrition rates (90.1% up to the intervention phase) the study was terminated before completion, since it would greatly limit the validity of any results. A post hoc qualitative study was performed on a subset of participants to gain insight into contributing factors for the high attrition rate. Issues negatively impacting participants' motivation to complete the program were identified, as well as elements of the program that received approval. The results from this study provide a first insight into the potential of the use of online cognitive bias modification (CBM) interventions in problem gambling (PG). Suggestions and directions for future studies are discussed.

Augmenting outpatient alcohol treatment as usual with online approach bias modification training: A double-blind randomized controlled trial.

Previous research shows that automatic tendency to approach alcohol plays a causal role in problematic alcohol use and can be retrained by Approach Bias Modification (ApBM). ApBM has been shown to be effective for patients diagnosed with alcohol use disorder (AUD) in inpatient treatment. This study aimed to investigate the effectiveness of adding an online ApBM to treatment as usual (TAU) in an outpatient setting compared to receiving TAU with an online placebo training. 139 AUD patients receiving face-to-face or online treatment as usual (TAU) participated in the study. The patients were randomized to an active or placebo version of 8 sessions of online ApBM over a 5-week period. The weekly consumed standard units of alcohol (primary outcome) was measured at pre-and post-training, 3 and 6 months follow-up. Approach tendency was measured pre-and-post ApBM training. No additional effect of ApBM was found on alcohol intake, nor other outcomes such as craving, depression, anxiety, or stress. A significant reduction of the alcohol approach bias was found. This research showed that approach bias retraining in AUD patients in an outpatient treatment setting reduces the tendency to approach alcohol, but this training effect does not translate into a significant difference in alcohol reduction between groups. Explanations for the lack of effects of ApBM on alcohol consumption are treatment goal and severity of AUD. Future ApBM research should target outpatients with an abstinence goal and offer alternative, more user-friendly modes of delivering ApBM training.

'A circuit breaker' - Interrupting the alcohol autopilot: A qualitative exploration of participants' experiences of a personalised mHealth approach bias modification intervention for alcohol use.

Objective: There is a need for low-cost, wide-reaching interventions to enhance accessibility of support for people with hazardous alcohol consumption. We assessed participant experiences of using a novel, personalised mHealth intervention offering approach bias modification (ApBM) for alcohol use in a community sample drinking at harmful levels to enable a deeper understanding of the end user and engagement. Methods: Eighteen semi-structured telephone interviews were conducted with adults in the community drinking at harmful/hazardous levels. A reflexive thematic analysis approach was used and data analysis followed iterative categorisation. Results: Engagement/Motivation and Clinical Value were overarching themes. The useable, accessible, customisable design described by participants enabled training to be readily integrated into routines, enhancing autonomy and self-efficacy beliefs, and facilitating engagement/motivation. Where autonomy or perceived self-efficacy were threatened by a rigid training schedule or lack of clarity/reminders, engagement was reduced. Training increased awareness of drinking behaviours, and encouraged participants to consider alternate goal-directed behaviours with feedback suggesting training may function as a 'circuit breaker', increasing time between alcohol craving and seeking, and enabling reflective processing, at least in the short term. Conclusions: This novel smartphone intervention for alcohol use may be a useful, accessible, 'just in time' adjunctive support tool for non-treatment seekers, meeting an important gap in the field. Findings have implications for the implementation of subsequent digital interventions, suggesting participants may stand to gain more from an intervention which enables autonomy and improves self-efficacy beliefs. Theoretically, findings speak to the role of inferential processing in behaviour change, but further research is needed to clearly elucidate ApBM training mechanisms. Practical recommendations for subsequent app iterations are suggested, along with additional opportunities worthy of consideration for future initiatives.

Preliminary efficacy of a digital therapeutics smartphone application for methamphetamine use disorder: An experimental study.

Methamphetamine is the most widely used illicit drug in China. Treating methamphetamine use disorder (MUD) is challenging due to the lack of effective pharmacotherapies. This study is an experimental study to investigate the efficacy of smartphone-based digital therapeutics in treating MUD at the community level. One hundred participants were recruited and randomized into a digital therapeutics (DTx) group (n = 52) and a treatment as usual (TAU) group (n = 48). The DTx group used a smartphone application to deliver cognitive behavioral therapy, approach bias modification, cognitive training, and contingency management for 8 weeks. The TAU group received counseling from social workers and professional psychotherapists. Cue-induced craving, cognitive functions, PHQ9, and GAD7 were measured at baseline and post-intervention. Wilcoxon tests were performed with bootstrap and multiply imputation to estimate the treatment effect size. The DTx group showed a significant reduction in drug craving [Wilcoxon effect size = -0.267, 95% CI = (-0.435, -0.099), p = 0.002] and a significant improvement in cognitive function [Wilcoxon effect size = 0.220, 95% CI = (0.009, 0.432), p = 0.041]. The DTx group had overall 1, 8, and 24-week attritions of 8%, 11.5%, and 38.5%, respectively. The study shows that Digital therapeutics is feasible and potentially beneficial as a complement to community substance use treatment programs.

The effect of approach bias modification during alcohol withdrawal treatment on craving, and its relationship to post-treatment alcohol use in a randomised controlled trial.

BACKGROUND: Approach bias modification (ApBM) for alcohol use disorder helps prevent relapse, yet the psychological mechanisms underlying its efficacy remain unclear. Alcohol craving predicts relapse and appears to be related to the biased processing of alcohol stimuli which is reduced by ApBM. However, there is little research examining whether ApBM reduces alcohol craving. METHODS: In a randomised controlled trial testing the effect of 4 ApBM sessions (vs. sham training) on post-treatment alcohol use in 300 alcohol withdrawal inpatients, we administered the Alcohol Craving Questionnaire - Short Form - Revised (ACQ-SF-R) pre and post-training and at 2-week, 3, 6 and 12-month follow ups; and a cue-induced craving measure pre and post training. RESULTS: Groups did not significantly differ in terms of declines in ACQ-SF-R total scores (p = .712) or cue-induced craving (p = .841) between the first and last training session, nor in terms of ACQ-SF-R scores at follow-ups (p = .509). However, the ACQ-SF-R Expectancy subscale, which assesses craving based on anticipated positive reinforcement from alcohol, was significantly lower in the ApBM group than in controls following training (p = .030), although the group x time interaction for this subscale was non-significant (p = .062). Post-intervention Expectancy scores mediated only a small portion of ApBM's effect on post-discharge alcohol use (14% in intention-to-treat analysis, p = .046; 15% in per-protocol analysis, p = .020). CONCLUSIONS: ApBM does not appear to have robust, sustained effects on alcohol craving. Reduced craving is unlikely to account for ApBM's relapse prevention effects. However, further research on whether ApBM's effects are related to devaluation of alcohol reward expectancy is warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617001241325.

Alcohol use in the year following approach bias modification during inpatient withdrawal: secondary outcomes from a double-blind, multi-site randomized controlled trial.

BACKGROUND AND AIMS: Approach bias modification (ApBM) targeting alcohol approach bias has been previously shown to reduce likelihood of relapse during the first 2 weeks following inpatient withdrawal treatment (IWT). We tested whether ApBM's effects endure for a longer period by analysing alcohol use outcomes 3, 6 and 12 months post-discharge. DESIGN: A double-blind, sham-controlled randomized controlled trial. SETTING: Four IWT units in Melbourne, Australia. PARTICIPANTS: Three hundred alcohol IWT patients (173 men, 126 women, 1 non-binary; mean age 43.5 years) were recruited between 4 June 2017 and 14 July 2019. Follow-up data collection was completed on 22 September 2020. INTERVENTION AND CONTROL TRAINING: Four ApBM sessions were delivered during IWT. ApBM trained participants (n = 147) to avoid alcohol and approach non-alcohol beverage cues. Controls (n = 153) responded to the same stimuli, but without approach/avoidance training. MEASUREMENTS: Date of first lapse was recorded for non-abstinent participants to determine time to first lapse. Time-line follow-back interviews assessed past-month alcohol consumption at each follow-up, with participants reporting no alcohol consumption classified as abstinent. In analyses of past-month abstinence, non-abstinence was assumed in participants lost to follow-up. Number of past-month drinking days, standard drinks and heavy drinking days (five or more standard drinks for women or non-binary; six or more standard drinks for men) were calculated for non-abstinent participants at each follow-up. FINDINGS: ApBM significantly delayed time to first lapse [ApBM median: 53 days, 95% confidence interval (CI) = 21-61; controls = 12 days, 95% CI = 9-21, P = 0.045]. Past-month abstinence rates at 3-, 6- and 12-month follow-ups were 33/153 (21.6%), 30/153 (19.6%), and 24/153 (15.7%) in controls; and 51/147 (34.7%), 30/147 (20.4%) and 29/147 (19.7%) in the ApBM group, respectively. Past-month abstinence was significantly more likely in ApBM participants than controls at the 3-month follow-up [odds ratio (OR) = 1.93, 95% CI = 1.16-3.23, P = 0.012], but not at 6- or 12-month follow-ups (6-month OR = 1.05, 95% CI = 0.60-1.95, P = 0.862; 12-month OR = 1.32, 95% CI = 0.73-2.40, P = 0.360). No significant group differences were found for indices of alcohol consumption in non-abstinent participants. CONCLUSIONS: Approach bias modification for alcohol delivered during inpatient withdrawal treatment helps to prevent relapse, increasing rates of abstinence from alcohol for at least 3 months post-discharge.

Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial.

BACKGROUND: Although effective treatments for smoking cessation are available, long-term abstinence is the exception rather than the norm. Accordingly, there is a need for novel interventions that potentially improve clinical outcome. Although implicit information processing biases, for example approach biases for smoking-related stimuli, are ascribed a dominant role in the maintenance of tobacco dependence, these biases are hardly targeted in current treatment. Past research has shown that so-called Approach Bias Modification (AppBM) trainings, aiming to modify this bias, lead to improved long-term abstinence in abstinent alcoholic inpatients when delivered as an add-on to treatment-as-usual. Findings on the efficacy of AppBM in smoking have been inconsistent. The present large-scale clinical trial pursues two goals. First, it aims to investigate the efficacy of AppBM as an add-on to treatment-as-usual in a representative sample of adult smokers. Second, possible mechanisms of change are investigated. METHODS: The study is a randomized-controlled, double-blind, parallel-group superiority trial. We aim at a final sample of at least 336 adult smokers. Participants are allocated with a 1:1:1 allocation ratio to one of the following conditions: (1) treatment-as-usual + AppBM, (2) treatment-as-usual + Sham, (3) treatment-as-usual only. During the add-on training, participants are presented smoking-related and positive pictures and are instructed to respond by either pushing or pulling a joystick, depending on the tilt of the pictures (5○ to the left/right). During AppBM, all smoking-related pictures are tilted in the direction that is associated with pushing, thereby aiming to train an avoidance bias for smoking. All positive pictures are tilted in the direction associated with pulling. During Sham, the contingency is 50/50. Participants are assessed before and after the intervention and at a 6-month follow-up. The primary outcome is prolonged abstinence, and secondary outcomes include smoking-related variables and psychological distress. Additionally, the motivational significance of smoking-related stimuli (i.e., approach bias, valence) is assessed with different experimental tasks (Approach-Avoidance Task; Single Target Implicit Association Test) and psychophysiological measures. DISCUSSION: This is the first large-scale clinical trial investigating the efficacy of AppBM as an add-on in smokers including a TAU only condition. Additionally, it is the first study to systematically investigate potential mechanisms mediating the effects of treatment on clinical outcome. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00019221 , 11/11/2019.

"Push it!" or "Hold it!"? A comparison of nicotine-avoidance training and nicotine-inhibition training in smokers motivated to quit.

RATIONALE: Recently, experimental paradigms have been developed to strengthen automatic avoidance or inhibitory responses for smoking cues. However, these procedures have not yet been directly compared regarding their effectiveness and mechanisms of action. OBJECTIVE: This study compared the effects of avoidance vs. inhibitory training as an add-on to a brief smoking cessation intervention. The standard Approach-Avoidance-Task (AAT) was adapted for both training types and control conditions. METHODS: One hundred twenty-four smokers attended behavioral counseling for smoking cessation and were thereafter randomized to one of four training conditions: avoidance-AAT, sham-avoidance-AAT, inhibition-AAT, sham-inhibition-AAT. During a 2-week training period including five training sessions, smokers in the avoidance-AAT trained to implicitly avoid all smoking-related cues, while smokers in the inhibition-AAT trained to implicitly inhibit behavioral response to smoking cues. During sham training, no such contingencies appeared. Self-report and behavioral data were assessed before and after training. Cigarette smoking and nicotine dependence were also assessed at 4- and 12-week follow-ups. RESULTS: At posttest, avoidance training was more effective in reducing daily smoking than inhibition training. However, this difference was no longer evident in follow-up assessments. All training conditions improved other smoking- and health-related outcomes. Neither training changed smoking-related approach biases or associations, but approach biases for smoking-unrelated pictures increased and Stroop interference decreased in all conditions. Smoking devaluation was also comparable in all groups. CONCLUSIONS: Avoidance training might be slightly more effective in reducing smoking than inhibitory training. Overall, however, all four training types yielded equivalent therapy and training effects. Hence, a clear preference for one type of training remains premature.

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000638932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/21278.

Participants' experience of approach bias modification training with transcranial Direct Current Stimulation as a combination treatment for binge eating disorder.

OBJECTIVE: This study explored participants' experience of approach bias modification training (ABM) with transcranial Direct Current Stimulation (tDCS) for binge eating disorder (BED) within a randomised controlled trial (RCT). A subset of participants who completed the RCT were interviewed to attain feedback on treatment experience and outcomes. METHOD: 15 participants with BED who completed the RCT were recruited, using purposive sampling. Participants received six sessions of concurrent ABM training with either real or sham tDCS. Semi-structured interviews relating to study experience and treatment outcomes were conducted and data were analysed thematically. RESULTS: The combined ABM and tDCS intervention was deemed acceptable and worthwhile by participants interviewed across both intervention groups. Negative preconceptions of tDCS were an initial deterrent to study participation for some, yet the brain stimulation experience was found to be tolerable. Minor and transient sensations and side effects attributed to tDCS were reported by most participants during and after stimulation, in addition to less pleasant aspects of ABM training, with no significant adverse effects reported by interviewees. Positive outcomes were described by participants across both intervention groups, relating to changes in BED symptoms and to broader beneficial effects on associated cognitive and emotional factors. Two participants experienced a shift in autonomy, attributed to tDCS and the combined intervention respectively. CONCLUSIONS: Adults with symptoms of BED found concurrent ABM and tDCS sessions to be acceptable, despite initial apprehension about the safety of tDCS. Findings are relevant to the neuroethics literature and may inform science communication strategies on neuromodulation treatments.

Pushing or Pulling Your "Poison": Clinical Correlates of Alcohol Approach and Avoidance Bias Among Inpatients Undergoing Alcohol Withdrawal Treatment.

Introduction: Alcohol approach bias, the tendency to automatically move toward alcohol cues, has been observed in people who drink heavily. However, surprisingly, some alcohol-dependent patients demonstrate an alcohol avoidance bias. This inconsistency could be explained by the clinical or demographic profile of the population studied, yet this has not been examined in approach bias modification (ABM) trials to date. We aimed to determine the proportion of patients with an approach or avoidance bias, assess whether they differ on demographic and drinking measures, and to examine the clinical correlates of approach bias. Method: These research questions were addressed using baseline data from 268 alcohol-dependent patients undergoing inpatient withdrawal treatment who then went on to participate in a trial of ABM. Results: At trial entry (day 3 or 4 of inpatient withdrawal), 155 (57.8%) had an alcohol approach bias and 113 (42.2%) had an avoidance bias. These two groups did not differ on any demographic or relevant drinking measures. Approach bias was significantly and moderately associated with total standard drinks consumed in the past 30 days (r = 0.277, p = 0.001) but no other indices of alcohol consumption or problem severity. Conclusion: Whilst the majority of alcohol-dependent patients showed an alcohol approach bias, those with an avoidance bias did not differ in demographic or clinical characteristics, and the strength of approach bias related only to recent consumption. Further research is needed to develop more accurate and personally tailored measures of approach bias, as these findings likely reflect the poor reliability of standard approach bias measures.

Approach bias retraining through virtual reality in smokers willing to quit smoking: A randomized-controlled study.

Automatic approach biases toward smoking-related cues have been implicated in the development and maintenance of addictive behaviors. Studies aiming at modifying such biases have shown promise in changing maladaptive approach tendencies for smoking cues and reducing smoking behavior. However, training effects tend to be small and partly inconsistent. The present randomized-controlled trial incorporated virtual reality (VR) technology into Approach Bias Modification (ABM) to improve efficacy. One-hundred-eight smokers attended behavioral counseling for smoking cessation and were thereafter randomized to receive VR-ABM or VR-control training. During VR-ABM, participants trained to implicitly avoid smoking-related objects and to approach alternative objects, while no such contingency existed in the VR-control condition. Trainings were administered in six sessions within a two-week period. Assessments were conducted at baseline, post-intervention (three weeks after baseline), and at follow-up (seven weeks after baseline). VR-ABM did not change approach biases, nor other cognitive biases, but it was superior in reducing daily smoking. However, this effect was limited to the two-week training period. Both groups improved in other smoking- and health-related variables across time. Future work should continue to investigate working mechanisms of ABM, in particular crucial training ingredients. VR could prove valuable for public health as the potential of VR-based treatments is large and not fully explored.

Approach avoidance training to curb consumption of sugar-sweetened beverages - A pilot randomized controlled trial in healthy volunteers.

Elevated consumption of sugar-sweetened beverages (SSBs) contributes to overweight and obesity. Automatic action tendencies like an approach bias might promote the consumption of SSBs. We investigated whether an Approach-Avoidance Training (AAT) reduces this approach bias and related behaviors like craving for and consumption of SSBs. Fifty-six healthy participants, with a self-reported SSB consumption of at least 330 ml per day, were randomized to 6 sessions of real or sham AAT. In the real AAT condition, participants were trained to react with avoidance movements to pictures of SSBs in an implicit learning paradigm (i.e. participants were instructed to respond to a task-irrelevant feature), whereas in the sham AAT condition the same pictures were used but no systematic (avoidance) reaction was trained. Approach bias, craving for SSB and SSB intake in a bogus taste test were assessed. Real AAT was not superior to sham AAT in any outcome measure. AAT in its current form and as a stand-alone intervention does not appear to be effective in reducing SSB consumption.

Imaginal Retraining Reduces Cigarette Smoking: A Randomized Controlled Study.

OBJECTIVES: Smoking is a highly prevalent addictive behavior with severe and life-shortening health consequences. This is the first study to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (ABM) (i.e., imaginal retraining) for the reduction of craving for tobacco and actual smoking behavior. METHODS: We randomized 345 smokers to imaginal retraining (self-help manual) or a control group (either active control or wait-list control). Assessments were carried out online. The treatment interval was 6 weeks. Craving for tobacco represented the primary outcome. The study was registered as DRKS00016860. RESULTS: Retention was 79.7% with no difference between groups. The intention-to-treat (ITT) analyses were significant for the primary outcome (Visual Analogue Scale on craving for tobacco) as well as subjective reduction of smoking (45.5 vs. 26.4%) in favor of imaginal retraining. In the treatment group, 47.6% performed the exercises at least once. This subgroup (per-protocol [PP] sample) showed a significant reduction in tobacco dependency as measured with the Cigarette Dependence Scale (short and long forms) and the Fagerström Test for Nicotine Dependence relative to controls. Number of daily cigarettes declined to a greater extent in imaginal retraining in the PP but not ITT analysis. A small dose-effect relationship emerged between craving and frequency of performance of the technique. CONCLUSION: When used regularly, imaginal retraining may reduce craving for tobacco and actual smoking behavior in a subgroup of smokers. In view of the large subgroup that did not read the manual or did not perform the exercises, alternative ways of conveying the imaginal retraining technique should be sought (e.g., demonstration via video clips). To conclude, imaginal retraining may represent a simple low-threshold technique to reduce smoking and assist current evidence-based treatment programs targeted at abstinence. It needs to be tested whether its mechanism of action deviates from standard ABM.

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.

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.

Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention for Adult Smokers Seeking Online Help: Double-Blind Randomized Controlled Trial.

BACKGROUND: Automatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent. OBJECTIVE: This study aimed to test the individual and combined effects of two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design. METHODS: A total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants' intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted. RESULTS: Only 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001). CONCLUSIONS: This RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions. TRIAL REGISTRATION: Netherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678.

Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication.

BACKGROUND: Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol for a feasibility randomised controlled trial (RCT) of approach bias modification (ABM) training combined with real versus sham (placebo) transcranial direct current stimulation (tDCS). The primary aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of ABM and tDCS in this group of participants. Second, the study will assess the preliminary efficacy of ABM + tDCS in reducing food cravings in people who take antipsychotic medication. METHODS: Thirty adults with a DSM-V diagnosis of schizophrenia or schizoaffective disorder treated with anti-psychotic medication will be randomly allocated to receive five sessions that will combine ABM and real or sham tDCS, in a parallel group design. In this feasibility study, a broad range of outcome variables will be examined. Measures will include food craving, psychopathology (e.g. symptoms of schizophrenia and depression), neuropsychological processes (such as attentional bias and impulsiveness), and the tolerability and acceptability of tDCS. The feasibility of conducting a large-scale RCT of ABM + tDCS and appropriateness of tDCS as a treatment for antipsychotic drug-induced weight gain will be evaluated by assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up). DISCUSSION: The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. In addition, results from this study will provide a preliminary indication of the efficacy of ABM + tDCS treatment for antipsychotic drug-induced weight gain. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN13280178. Registered on 16 October 2018.

Promoting smoking abstinence in smokers willing to quit smoking through virtual reality-approach bias retraining: a study protocol for a randomized controlled trial.

BACKGROUND: Automatic processes to approach smoking-related cues have been repeatedly linked to smoking status, intensity of smoking, and cigarette craving. Moreover, recent findings suggest that targeting those tendencies directly by means of approach bias modification (ABM) has merit in changing maladaptive approach tendencies for drug cues and reducing drug consumption. However, training effects tend to be small. Embedding the training into virtual reality (VR) technology could be a promising way to improve training efficacy. The present protocol describes a randomized controlled trial that aims to assess the efficacy of a newly developed VR-ABM as a means of reducing smoking-related approach biases or nicotine consumption in smokers seeking abstinence. METHODS: One hundred daily smokers who are motivated to quit smoking will be recruited into the randomized controlled trial. All participants will attend a brief smoking cessation intervention (TAU) and will be randomly assigned either to the experimental (VR-avoidance training) or the placebo-control group (VR-placebo training). During the VR-avoidance training, participants are implicitly instructed to make an avoidance movement in response to smoking-related objects (e.g., cigarettes) and an approach movement in response to alternative objects (e.g., healthy food). During the VR-placebo training, no such contingency between arm movement and item content exists. Trainings are administered in six sessions within two weeks. Training effects on automatic approach tendencies and smoking behavior are measured immediately after training and at a 7-week follow-up. DISCUSSION: Embedding the training into virtual reality (VR) technology could be a promising new way to improve ecological validity, realism, and immersion and thereby increase ABM training effects. The results of this study can inform future research in the optimization and advancement of treatment for addiction. TRIAL REGISTRATION: Registered with Current Controlled Trials: study ID ISRCTN16006023. Registered on 28 March 2019.

Feasibility and acceptability of approach bias modification during methamphetamine withdrawal and related methamphetamine use outcomes.

Approach bias modification (ApBM), a computerised cognitive training task which aims to reduce automatic, impulsive responding to drug-related cues, has been found to reduce alcohol consumption among individuals seeking treatment for their drinking. However, this approach has not been trialled in patients with methamphetamine use disorder (MUD), where altered impulsivity and reward processing are well-established. As such, this study aimed to examine the feasibility and acceptability of four consecutive days of ApBM training during a residential admission for methamphetamine withdrawal. Abstinence rates were examined 2-weeks and 3-months post-discharge. In terms of uptake, 52 of the 99 eligible patients approached agreed to participate and 47 of these 52 commenced training. Uptake and training completion rates (62%) were lower than those achieved in similar trials of ApBM for residential alcohol withdrawal, suggesting there are challenges to its delivery in this setting. This is likely due to the severity of acute methamphetamine withdrawal syndrome and associated behavioural characteristics. However, participants' ratings of the task and reports of post-session craving suggest acceptability was high. Abstinence rates were 61% at 2 weeks and 54% at 3-months, which compare favourably with the abstinence rates observed in a previous large treatment outcome study. The evidence of acceptability and apparent effectiveness suggest future trials of ApBM with MUD patients are warranted. However, ApBM may be more feasible in certain settings or among particular sub-groups where patients are more clinically stable and therefore more likely to complete the training (e.g., residential rehabilitation, after acute withdrawal has subsided).