Web-based intervention for young adults experiencing anxiety and hazardous alcohol use: Study protocol for an 18-month randomized controlled trial.

BACKGROUND AND AIMS: Alcohol use and anxiety often co-occur, causing increased severity impairment. This protocol describes a randomized controlled trial (RCT) that aims to test the efficacy and cost-effectiveness of a web-based, self-guided alcohol and anxiety-focused program, compared with a web-based brief alcohol-focused program, for young adults who drink at hazardous levels and experience anxiety. It will also test moderators and mechanisms of change underlying the intervention effects. DESIGN: This RCT will be conducted with a 1:1 parallel group. SETTING: The study will be a web-based trial in Australia. PARTICIPANTS: Individuals aged 17-30 years who drink alcohol at hazardous or greater levels and experience at least mild anxiety (n = 500) will be recruited through social media, media (TV, print) and community networks. INTERVENTION AND COMPARATOR: Participants will be randomly allocated to receive a web-based, integrated alcohol-anxiety program plus technical and motivational telephone/e-mail support (intervention) or a web-based brief alcohol-feedback program (control). MEASUREMENTS: Clinical measures will be assessed at baseline, post-intervention (2 months), 6 months (primary end-point), 12 months and 18 months. Co-primary outcomes are hazardous alcohol consumption and anxiety symptom severity. Secondary outcomes are binge-drinking frequency; alcohol-related consequences; depression symptoms; clinical diagnoses of alcohol use or anxiety disorder (at 6 months post-intervention), health-care service use, educational and employment outcomes; and quality of life. Mediators and moderators will also be assessed. Efficacy will be tested using mixed models for repeated measures within an intention-to-treat framework. The economic evaluation will analyze individual-level health and societal costs and outcomes of participants between each trial arm, while mediation models will test for mechanisms of change. COMMENTS: This will be the first trial to test whether a developmentally targeted, web-based, integrated alcohol-anxiety intervention is effective in reducing hazardous alcohol use and anxiety severity among young adults. If successful, the integrated alcohol-anxiety program will provide an accessible intervention that can be widely disseminated to improve wellbeing of young adults, at minimal cost.

The effectiveness of a home-based dietetic intervention for community-dwelling older adults.

OBJECTIVES: The aim of this study was to describe the characteristics of clients receiving home-based dietetic intervention and to evaluate the effectiveness of these interventions in improving nutritional status, functional status, and quality of life in a culturally and socioeconomically diverse client group. METHODS: Participants referred to a home-based dietetic service were recruited to this prospective cohort study. Dietetic interventions were recommended at baseline and reviewed at 3-month follow-up. Assessment of nutritional, functional and quality of life markers was measured using the Mini Nutritional Assessment (MNA), Timed Up and Go (TUG) and EQ-5D-5L, respectively, at baseline and after home-based dietetic intervention. RESULTS: Participants (n = 99) were recruited from consecutive referrals. Participant's weight, body mass index (BMI), total daily energy and protein intake, MNA total score, and TUG significantly improved after a 3-month nutrition intervention (effect sizes 0.257, 0.257, 0.580, 0.533, 0.577 and 0.281, respectively). The most common interventions dietitians utilised were nutrition education, use of oral nutritional supplements (ONS) and meal fortification. In total, 339 dietetic interventions were recommended to participants at baseline with 197 (58.11%) implemented at 3 months, with meal planning and referral to other relevant allied health or Commonwealth Home Support Program (CHSP) services the most implemented interventions. CONCLUSIONS: Home-based dietetic intervention improves nutritional status, functional status and quality of life in community-dwelling older adults referred for dietetic input. Improvements observed in nutritional and functional status were consistent with benchmarks of change from published literature.

The Impact of Personal Protective Equipment on Cognitive and Emotional Aspects of Health Care Work.

OBJECTIVE: Personal protective equipment (PPE) is critical to the safety of health professionals and vital to clinical practice. However, there is little known about the cognitive and emotional impact of PPE on health professionals' performance, comfort, and well-being. METHODS: A mixed-method, cross-sectional, observational study was adopted. An online survey consisting of 5-point Likert scale questions and free-text comments canvassed the opinions of patient-facing health professionals. RESULTS: An overall negative impact of PPE on health professionals' ability to carry out work was found from 185 responses from medicine, nursing, and allied health disciplines, including increased fatigue, poor communication, and feeling uncomfortable. CONCLUSIONS: There are significant negative impacts of PPE on health professionals' ability to carry out work, impairing communication, task efficiency, and comfort. Personal protective equipment is an essential infection control practice requiring further research, design, and testing to overcome challenges.

Web-Based Cognitive Bias Modification Program for Young People With Social Anxiety and Hazardous Alcohol Use: Feasibility, Acceptability, and Preliminary Efficacy Study.

BACKGROUND: Interpretation bias modification (IBM) and approach bias modification (ApBM) cognitive retraining interventions can be efficacious adjunctive treatments for improving social anxiety and alcohol use problems. However, previous trials have not examined the combination of these interventions in a young, comorbid sample. OBJECTIVE: This study aims to describe the feasibility, acceptability, and preliminary efficacy of a web-based IBM+ApBM program for young adults with social anxiety and hazardous alcohol use ("Re-Train Your Brain") when delivered in conjunction with treatment as usual (TAU). METHODS: The study involved a 3-arm randomized controlled pilot trial in which treatment-seeking young adults (aged 18-30 y) with co-occurring social anxiety and hazardous alcohol use were randomized to receive (1) the "integrated" Re-Train Your Brain program, where each session included both IBM and ApBM (50:50 ratio), plus TAU (35/100, 35%); (2) the "alternating" Re-Train Your Brain program, where each session focused on IBM or ApBM in an alternating pattern, plus TAU (32/100, 32%); or (3) TAU only (33/100, 33%). Primary outcomes included feasibility and acceptability, and secondary efficacy outcomes included changes in cognitive biases, social anxiety symptoms, and alcohol use. Assessments were conducted at baseline, after the intervention period (6 weeks after baseline), and 12 weeks after baseline. RESULTS: Both Re-Train Your Brain program formats were feasible and acceptable for young adults. When coupled with TAU, both integrated and alternating programs resulted in greater self-reported improvements than TAU only in anxiety interpretation biases (at the 6-week follow-up; Cohen d=0.80 and Cohen d=0.89) and comorbid interpretation biases (at the 12-week follow-up; Cohen d=1.53 and Cohen d=1.67). In addition, the alternating group reported larger improvements over the control group in generalized social anxiety symptoms (at the 12-week follow-up; Cohen d=0.83) and alcohol cravings (at the 6-week follow-up; Cohen d=0.81). There were null effects on all other variables and no differences between the intervention groups in efficacy outcomes. CONCLUSIONS: Should these findings be replicated in a larger randomized controlled trial, Re-Train Your Brain has the potential to be a scalable, low-cost, and non-labor-intensive adjunct intervention for targeting interpretation and comorbidity biases as well as generalized anxiety and alcohol-related outcomes in the real world. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/28667.

Impaired Decision-Making and Skin Conductance Responses Are Associated with Reward and Punishment Sensitivity in Individuals with Severe Alcohol Use Disorder.

INTRODUCTION: Individuals with alcohol use disorder (AUD) have difficulties regulating alcohol consumption, despite adverse drinking-related consequences. This may be due to incapacity incorporating previous negative feedback from drinking, resulting in impaired decision-making. METHODS: We assessed whether decision-making is impaired in participants with AUD related to severity of AUD, indexed by severe negative drinking consequences using the Drinkers Inventory of Consequences (DrInC) and reward and punishment sensitivity with the Behavioural Inhibition System Behavioural Activation System (BIS BAS) scales. 36 treatment-seeking alcohol-dependent participants completed the Iowa gambling task (IGT) with skin conductance responses (SCRs) measured continuously as an index of somatic autonomic arousal to evaluate impaired expectancy of negative outcomes. RESULTS: Two-thirds of the sample showed behavioural impairment during the IGT, with greater AUD severity related to worse performance. BIS moderated IGT performance according to severity of AUD, with increased anticipatory SCRs for those with fewer reported DrInC severe consequences. Participants with more DrInC severe consequences showed IGT deficits and reduced SCRs regardless of BIS scores. BAS-Reward was associated with increased anticipatory SCRs to disadvantageous deck choices among those with lower AUD severity, while SCRs did not differ related to AUD severity for reward outcomes. DISCUSSION: Effective decision-making in the IGT and adaptive somatic responses were moderated by punishment sensitivity contingent on severity of AUD in these drinkers, with impairments in expectancy to negative outcomes from risky choices, including reduced somatic responses, resulting in poor decision-making processes that may help explain impaired drinking and worse drinking-related consequences.

Are we making Inroads? A randomized controlled trial of a psychologist-supported, web-based, cognitive behavioral therapy intervention to reduce anxiety and hazardous alcohol use among emerging adults.

BACKGROUND: Anxiety and alcohol use disorders are common and disabling conditions that people typically endure for many years before accessing treatment. The link between anxiety and alcohol use is well-established, with these issues commonly emerging and/or escalating during emerging adulthood. This randomized controlled trial evaluated a psychologist-supported, web-based intervention, designed with and for emerging adults, that aims to promote adaptive coping strategies, and prevent anxiety and alcohol use from progressing to chronic, mutually-reinforcing disorders. METHODS: Between December 2017 and September 2018, 123 emerging adults (aged 17-24) reporting anxiety symptoms and hazardous alcohol use were randomized to receive the Inroads or control (assessment plus alcohol information) intervention. The Inroads program combined five web-based cognitive behavioral therapy modules with weekly psychologist support via email/phone. Primary outcomes were alcohol consumption, severity of alcohol-related consequences, and general anxiety symptoms, assessed at baseline, 2 and 6-months post-baseline. Secondary outcomes included hazardous alcohol use and social anxiety. Trial Registration: Prospectively registered in the Australian New Zealand Clinical Trials Registry, ACTRN12617001609347. FINDINGS: Alcohol consumption and associated consequences reduced in both groups, with the Inroads group reporting greater alcohol reductions by 6-month follow-up (mean difference -0.74, 95% CI: -1.47 to -0.01, d = 0.24). Relative to controls, hazardous alcohol use reduced among Inroads participants at both follow-ups (2-month mean difference -2.14, 95% CI: -4.06 to -0.22). Inroads participants also reported reduced symptoms of general (mean difference -3.06, 95% CI: -4.97 to -1.15, d = 0.88) and social anxiety (mean difference -3.21, 95% CI: -6.34 to -0.07, d = 0.32) at 2-month follow-up, with improvements in social anxiety sustained at 6-months. INTERPRETATION: The Inroads program demonstrated beneficial effects on alcohol consumption, hazardous alcohol use, and anxiety symptoms. The web-based format is aligned with youth treatment preferences and can be delivered at scale to achieve wide dissemination and reduce the significant burden associated with these chronic, mutually reinforcing conditions. FUNDING: Australian Rotary Health, Australian National Health and Medical Research Council.

New Australian guidelines for the treatment of alcohol problems: an overview of recommendations.

OF RECOMMENDATIONS AND LEVELS OF EVIDENCE: Chapter 2: Screening and assessment for unhealthy alcohol use Screening Screening for unhealthy alcohol use and appropriate interventions should be implemented in general practice (Level A), hospitals (Level B), emergency departments and community health and welfare settings (Level C). Quantity-frequency measures can detect consumption that exceeds levels in the current Australian guidelines (Level B). The Alcohol Use Disorders Identification Test (AUDIT) is the most effective screening tool and is recommended for use in primary care and hospital settings. For screening in the general community, the AUDIT-C is a suitable alternative (Level A). Indirect biological markers should be used as an adjunct to screening (Level A), and direct measures of alcohol in breath and/or blood can be useful markers of recent use (Level B). Assessment Assessment should include evaluation of alcohol use and its effects, physical examination, clinical investigations and collateral history taking (Level C). Assessment for alcohol-related physical problems, mental health problems and social support should be undertaken routinely (GPP). Where there are concerns regarding the safety of the patient or others, specialist consultation is recommended (Level C). Assessment should lead to a clear, mutually acceptable treatment plan which specifies interventions to meet the patient's needs (Level D). Sustained abstinence is the optimal outcome for most patients with alcohol dependence (Level C). Chapter 3: Caring for and managing patients with alcohol problems: interventions, treatments, relapse prevention, aftercare, and long term follow-up Brief interventions Brief motivational interviewing interventions are more effective than no treatment for people who consume alcohol at risky levels (Level A). Their effectiveness compared with standard care or alternative psychosocial interventions varies by treatment setting. They are most effective in primary care settings (Level A). Psychosocial interventions Cognitive behaviour therapy should be a first-line psychosocial intervention for alcohol dependence. Its clinical benefit is enhanced when it is combined with pharmacotherapy for alcohol dependence or an additional psychosocial intervention (eg, motivational interviewing) (Level A). Motivational interviewing is effective in the short term and in patients with less severe alcohol dependence (Level A). Residential rehabilitation may be of benefit to patients who have moderate-to-severe alcohol dependence and require a structured residential treatment setting (Level D). Alcohol withdrawal management Most cases of withdrawal can be managed in an ambulatory setting with appropriate support (Level B). Tapering diazepam regimens (Level A) with daily staged supply from a pharmacy or clinic are recommended (GPP). Pharmacotherapies for alcohol dependence Acamprosate is recommended to help maintain abstinence from alcohol (Level A). Naltrexone is recommended for prevention of relapse to heavy drinking (Level A). Disulfiram is only recommended in close supervision settings where patients are motivated for abstinence (Level A). Some evidence for off-label therapies baclofen and topiramate exists, but their side effect profiles are complex and neither should be a first-line medication (Level B). Peer support programs Peer-led support programs such as Alcoholics Anonymous and SMART Recovery are effective at maintaining abstinence or reductions in drinking (Level A). Relapse prevention, aftercare and long-term follow-up Return to problematic drinking is common and aftercare should focus on addressing factors that contribute to relapse (GPP). A harm-minimisation approach should be considered for patients who are unable to reduce their drinking (GPP). Chapter 4: Providing appropriate treatment and care to people with alcohol problems: a summary for key specific populations Gender-specific issues Screen women and men for domestic abuse (Level C). Consider child protection assessments for caregivers with alcohol use disorder (GPP). Explore contraceptive options with women of reproductive age who regularly consume alcohol (Level B). Pregnant and breastfeeding women Advise pregnant and breastfeeding women that there is no safe level of alcohol consumption (Level B). Pregnant women who are alcohol dependent should be admitted to hospital for treatment in an appropriate maternity unit that has an addiction specialist (GPP). Young people Perform a comprehensive HEEADSSS assessment for young people with alcohol problems (Level B). Treatment should focus on tangible benefits of reducing drinking through psychotherapy and engagement of family and peer networks (Level B). Aboriginal and Torres Strait Islander peoples Collaborate with Aboriginal or Torres Strait Islander health workers, organisations and communities, and seek guidance on patient engagement approaches (GPP). Use validated screening tools and consider integrated mainstream and Aboriginal or Torres Strait Islander-specific approaches to care (Level B). Culturally and linguistically diverse groups Use an appropriate method, such as the "teach-back" technique, to assess the need for language and health literacy support (Level C). Engage with culture-specific agencies as this can improve treatment access and success (Level C). Sexually diverse and gender diverse populations Be mindful that sexually diverse and gender diverse populations experience lower levels of satisfaction, connection and treatment completion (Level C). Seek to incorporate LGBTQ-specific treatment and agencies (Level C). Older people All new patients aged over 50 years should be screened for harmful alcohol use (Level D). Consider alcohol as a possible cause for older patients presenting with unexplained physical or psychological symptoms (Level D). Consider shorter acting benzodiazepines for withdrawal management (Level D). Cognitive impairment Cognitive impairment may impair engagement with treatment (Level A). Perform cognitive screening for patients who have alcohol problems and refer them for neuropsychological assessment if significant impairment is suspected (Level A). SUMMARY OF KEY RECOMMENDATIONS AND LEVELS OF EVIDENCE: Chapter 5: Understanding and managing comorbidities for people with alcohol problems: polydrug use and dependence, co-occurring mental disorders, and physical comorbidities Polydrug use and dependence Active alcohol use disorder, including dependence, significantly increases the risk of overdose associated with the administration of opioid drugs. Specialist advice is recommended before treatment of people dependent on both alcohol and opioid drugs (GPP). Older patients requiring management of alcohol withdrawal should have their use of pharmaceutical medications reviewed, given the prevalence of polypharmacy in this age group (GPP). Smoking cessation can be undertaken in patients with alcohol dependence and/or polydrug use problems; some evidence suggests varenicline may help support reduction of both tobacco and alcohol consumption (Level C). Co-occurring mental disorders More intensive interventions are needed for people with comorbid conditions, as this population tends to have more severe problems and carries a worse prognosis than those with single pathology (GPP). The Kessler Psychological Distress Scale (K10 or K6) is recommended for screening for comorbid mental disorders in people presenting for alcohol use disorders (Level A). People with alcohol use disorder and comorbid mental disorders should be offered treatment for both disorders; care should be taken to coordinate intervention (Level C). Physical comorbidities Patients should be advised that alcohol use has no beneficial health effects. There is no clear risk-free threshold for alcohol intake. The safe dose for alcohol intake is dependent on many factors such as underlying liver disease, comorbidities, age and sex (Level A). In patients with alcohol use disorder, early recognition of the risk for liver cirrhosis is critical. Patients with cirrhosis should abstain from alcohol and should be offered referral to a hepatologist for liver disease management and to an addiction physician for management of alcohol use disorder (Level A). Alcohol abstinence reduces the risk of cancer and improves outcomes after a diagnosis of cancer (Level A).

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.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28667.

The impact of alcohol use disorders and alcohol consumption on treatment-seeking individuals with social anxiety disorder.

Comorbid social anxiety and alcohol use disorders (SAD-AUD) in the community and the complex interactions that occur between these disorders have emerged as a significant clinical, public health, and research issue. The authors examined (a) the rates of comorbid SAD-AUD, (b) the impact of comorbid SAD-AUD on outcomes targeting social anxiety disorder, and (c) the effect of pretreatment alcohol consumption and alcohol use before, during, and after social situations on a composite measure of social anxiety in 172 adults presenting with social anxiety disorder. There was low incidence of AUD in this sample of individuals with SAD. Results indicated that alcohol consumption did not lead to worse social anxiety symptoms; however, alcohol use before and during social situations was associated with more severe social anxiety symptoms. These findings suggest that the function of alcohol use may be more important than the overall level of alcohol use and has implications for treatment.

A detailed hierarchical model of psychopathology: From individual symptoms up to the general factor of psychopathology.

Much of our knowledge about the relationships among domains of psychopathology is built on the diagnostic categories described in the Diagnostic and Statistical Manual of Mental Disorders (DSM), with relatively little research examining the symptom-level structure of psychopathology. The aim of this study was to delineate a detailed hierarchical model of psychopathology-from individual symptoms up to a general factor of psychopathology-allowing both higher- and lower-order dimensions to depart from the structure of the DSM. We explored the hierarchical structure of hundreds of symptoms spanning 18 DSM disorders, in two large samples-one from the general population in Australia (n = 3175), and the other a treatment-seeking clinical sample from the USA (n = 1775). There was marked convergence between the two samples, offering new perspectives on higher-order dimensions of psychopathology. We also found several noteworthy departures from the structure of the DSM in the symptom-level data.

High-dose baclofen attenuates insula activation during anticipatory anxiety in treatment-seeking alcohol dependant individuals: Preliminary findings from a pharmaco-fMRI study.

The GABA B agonist, baclofen, has been shown to reduce alcohol consumption in patients with alcohol use disorder and also those with comorbid anxiety. This study aimed to evaluate the effect of baclofen versus placebo on the BOLD response during an anticipatory anxiety fMRI task in treatment seeking alcohol patients. Participants included 28 alcohol dependant individuals who had received daily baclofen 30 mg (n = 10), 75 mg (n = 8) or placebo (n = 10) for at least 2 week on a randomized controlled trial (Morley, Leung et al. 2013, Morley, Baillie et al. 2018). Using functional magnetic resonance imaging (fMRI), we examined threat cue-elicited neural activation during a threat reactivity task 120 min following administration of BAC (30 mg or 75 mg) or placebo. Whole-brain analyses revealed no significant differences between the combined BAC doses versus PL. However, there were significant decreases in anticipatory threat cue-elicited activation observed in BAC 75 mg/day compared to PL participants in the insula. In response to threat cues, high dose (75 mg/day) baclofen administration attenuates activation in the insula and inferior frontal gyrus, relative to placebo. These preliminary findings suggests that modulating emotional regulation and attentional allocation during high threat stimuli may be mediated by GABA B receptors and may be a potential mechanism of action for baclofen's beneficial treatment effects for alcohol use disorder.

Baclofen attenuates fMRI alcohol cue reactivity in treatment-seeking alcohol dependent individuals.

RATIONALE: Baclofen has been shown to effect fMRI alcohol cue reactivity in alcohol dependence, but potential varying effects related to baclofen dose levels have not been examined. OBJECTIVE: This study investigated whether baclofen attenuates craving and alcohol cue-elicited activation in alcohol-dependent treatment seekers, and the relationship between this response and clinical outcomes (Morley et al. 2018; Morley et al. 2013). METHODS: Participants included 30 alcohol-dependent individuals who had received daily baclofen 30 mg (n = 11), 75 mg (n = 8) or placebo (n = 11) for at least 2 weeks. Using functional magnetic resonance imaging (fMRI), we examined alcohol cue-elicited neural activation during a visual alcohol cue reactivity task 120 min following treatment administration, and alcohol cue reactivity and percentage of heavy drinking days (% HDD) associations were assessed. RESULTS: Both baclofen-treated groups reported fewer post-scan % HDD when compared to the placebo-treated group, but no subjective craving group differences were found. Increased alcohol cue-elicited activation was seen in placebo compared to the 75 mg/day baclofen participants in two clusters spanning prefrontal regions implicated in cue reactivity, chiefly frontal regions (i.e., frontal and precentral gyri, anterior cingulate cortex), but no observed alcohol cue reactivity differences between placebo and 30 mg/day baclofen groups. Post-scan % HDD was positively correlated with increased alcohol cue-elicited activation in a cluster encompassing the bilateral caudate nucleus and dorsal anterior cingulate cortex when comparing placebo versus 75 mg/day baclofen groups, and several clusters including prefrontal and mesolimbic regions when comparing placebo versus 30 mg/day baclofen groups. CONCLUSIONS: Baclofen administration attenuates alcohol cue-elicited activation and reduced the association in baclofen-treated participants between increased activity in key drug cue reactivity regions and higher post-scan % HDD observed in placebo-treated participants, suggesting a dose-specific response effect that may lead to reduced heavy drinking in chronic alcohol-dependent individuals. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01711125, https://clinicaltrials.gov/ct2/show /NCT01711125.

Altered Neurocognitive Functional Connectivity and Activation Patterns Underlie Psychopathology in Preadolescence.

BACKGROUND: Neurocognitive deficits are common among youth with mental disorders, and patterns of aberrant brain function generally cross diagnostic boundaries. This study investigated associations between functional neurocircuitry and broad transdiagnostic psychopathology dimensions in the critical preadolescent period when psychopathology is emerging. METHODS: Participants were 9- to 10-year-olds from the Adolescent Brain Cognitive Development Study. Factor scores of general psychopathology, externalizing, internalizing, and thought disorder dimensions were calculated from a higher-order model of psychopathology using confirmatory factor analysis (N = 11,721) and entered as explanatory variables into linear mixed models to examine associations with resting-state functional connectivity (n = 9074) and neural activation during the emotional n-back task (n = 6146) when covarying for sex, race/ethnicity, parental education, and cognitive function. RESULTS: All dimensions of psychopathology were commonly characterized by hypoconnectivity within the dorsal attention and retrosplenial-temporal networks, hyperconnectivity between the frontoparietal and ventral attention networks and between the dorsal attention network and amygdala, and hypoactivation of the caudal middle frontal gyrus. Externalizing pathology was uniquely associated with hyperconnectivity between the salience and ventral attention networks and hyperactivation of the cingulate and striatum. Internalizing pathology was uniquely characterized by hypoconnectivity between the default mode and cingulo-opercular networks. Connectivity between the cingulo-opercular network and putamen was uniquely higher for internalizing pathology and lower for thought disorder pathology. CONCLUSIONS: These findings provide novel evidence that broad psychopathology dimensions are characterized by common and dissociable patterns, particularly for externalizing pathology, of functional connectivity and task-evoked activation throughout neurocognitive networks in preadolescence.

Randomised controlled trial of integrated cognitive behavioural treatment and motivational enhancement for comorbid social anxiety and alcohol use disorders.

OBJECTIVE: Alcohol use disorder and social anxiety disorder are interconnected disorders that commonly co-occur. We report the first trial to assess whether integrated treatment for social anxiety and alcohol use disorder comorbidity improves outcomes relative to standard alcohol-focussed treatment. METHOD: Participants were recruited to a randomised controlled trial, and randomly allocated to one of two treatments, Integrated (n = 61) or Control (alcohol-focussed; n = 56). Assessment and treatment session were conducted at two sites in Sydney, Australia. Inclusion criteria were as follows: (1) clinical diagnosis of social anxiety disorder and (2) Diagnosis or sub-clinical symptoms of alcohol use disorder. Diagnoses were determined according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). All participants (n = 117) received 10 sessions of cognitive behavioural treatment and motivational enhancement. The Integrated treatment simultaneously targeted social anxiety disorder, alcohol use disorder and the connections between these disorders. The Control treatment focussed on alcohol use disorder only. Outcomes were assessed at 6-month follow-up, with interim assessments at post-treatment and 3 months. Primary outcomes were social anxiety disorder severity (composite Social Phobia Scale and Social Interaction Anxiety Scale), alcohol use disorder severity (standard drinks per day and Severity of Alcohol Dependence Questionnaire) and quality of life (Short-Form Health survey) was assessed to capture the combined impairment of social anxiety and alcohol use disorder comorbidity. RESULTS: At 6-month follow-up, both conditions showed significant reductions in social anxiety and alcohol use disorder symptoms, and improved quality of life. There was no evidence of between-condition differences for alcohol outcomes, with mean consumption reduced by 5.0 (0.8) and 5.8 (1.0) drinks per day following Alcohol and Integrated treatments, respectively. Integrated treatment achieved greater improvements in social anxiety symptoms (mean difference = -14.9, 95% confidence interval = [-28.1, -1.6], d = 0.60) and quality of life (mean difference = 7.6, 95% confidence interval = [1.2, 14.0], d = 0.80) relative to alcohol-focused treatment. CONCLUSION: These results suggest that integrated social anxiety and alcohol use disorder treatment enhances quality of life and social anxiety disorder symptom improvement, but not alcohol outcomes, compared to treatment focussed on alcohol use disorder alone.

Acceptability and Co-Development of an Online Cognitive Bias Modification Intervention for Emerging Adults With Hazardous Alcohol Use and Social Anxiety: A Mixed Methods Study.

BACKGROUND: Approach bias modification (ApBM) and interpretation bias modification (IBM) are two promising adjunct treatments for alcohol use and social anxiety, respectively. However, the acceptability of combining ApBM and IBM into one program for people who experience both of these disorders is unknown. The present study describes the codevelopment of a new, hybrid ApBM + IBM program and provides insight into the perceptions of acceptability from service providers and emerging adults. METHODS: Service providers (n = 14) and emerging adults aged 18 to 25 years with lived experience of hazardous alcohol use and heightened social anxiety (n = 15) were recruited via online advertisements and through existing networks. All participants were shown a beta version of the program and asked to complete qualitative and quantitative questions to ascertain feedback on the program's acceptability and suggestions for improvement. RESULTS: Themes emerged relating to the ApBM + IBM program's quality and usefulness, appropriateness, motivation and engagement, and potential clinical value. The program was well received and deemed acceptable for the target age group. It was rated particularly highly with regard to the overall quality and ease of use. Emerging adults had fewer suggestions for how the intervention might be revised; however, there were suggestions from both groups regarding the need for a compelling rationale at the outset of treatment and a suggestion to include a motivational interviewing and psychoeducational-based module prior to the first training session, to increase user buy-in and engagement. CONCLUSIONS: The current findings reflect positively on the acceptability of a hybrid ApBM + IBM for emerging adults with co-occurring hazardous alcohol use and social anxiety. Service providers and emerging adults identified a number of ways to improve the design and implementation of the program, which will likely improve adherence to, and outcomes of, the intervention when added as an adjunct to treatment as usual.

Development of the Macquarie Anxiety Behavioural Scale (MABS): A parent measure to assess anxiety in children and adolescents including young people with autism spectrum disorder.

OBJECTIVE: This study examined measurement variance for Autism Spectrum Disorder (ASD) in the Spence Children's Anxiety Scale - Parent Form (SCAS-P; Spence, 1999). In addition, we developed and evaluated a new parent report measure for anxiety (Macquarie Anxiety Behavioural Scale; MABS). METHOD: The sample consisted of 734 parents of children aged 3-19 years (i) who were seeking help for their child's anxiety, (ii) who had received a diagnosis of ASD, or (iii) from the community. RESULTS: Evidence for measurement variance of the SCAS-P and MABS was found, revealing different factor structures between the ASD and non-ASD groups. MIMIC modelling showed that the scales performed significantly different across ASD and non-ASD groups. Differential item functioning on a number of the SCAS-P and MABS items was also found. LIMITATIONS: This study relied on parent report of symptoms and of community acquired diagnoses of ASD. CONCLUSION: The MABS is a new parent measure to assess anxiety in children and adolescents and the proposed factor structure produced a reasonably good fit for the data. Similar to the SCAS-P, ASD was found to impact on some of the MABS items indicating that ASD influences parental responding. Eighteen MABS items showed measurement invariance across the anxious and ASD groups and can be considered suitable items for the assessment of anxiety in ASD.

Baclofen modulates cardiovascular responses to appetitive cues in treatment-seeking alcohol use disorder individuals.

OBJECTIVE: To assess whether baclofen-treated alcohol dependent participants show different subjective and psychophysiological responses to appetitive cues during an alcohol cue reactivity task compared to placebo, and whether these responses are associated with prospective drinking outcomes. METHODS: Forty-two alcohol dependent participants (placebo: n = 12, low-dose baclofen [30 mg/day] n = 18, high-dose baclofen [75 mg/day]: n = 12) completed an alcohol cue reactivity task, whereby water and alcohol beverage cues were presented, with subsequent recovery periods, and subjective alcohol craving and psychophysiological indices (skin conductance; cardiovascular measures: heart rate, high-frequency heart rate variability) were recorded. RESULTS: High-dose baclofen-treated participants showed both overall cue reactivity to water and alcohol cues and greater recovery effects during recovery periods, revealed by high-frequency heart rate variability, when compared to low-dose- and placebo-treated participants. There were no medication effects on subjective craving. In high-dose baclofen participants only, there was a predictive effect of lower baseline heart rate variability and fewer post-test percentage of heavy drinking days. CONCLUSION: There was a dose-specific rescuing effect of high-dose baclofen on the dynamic modulation of cardiovascular responses to eliciting cues. Investigation of treatment responses using psychophysiological techniques may elucidate baclofen's mechanisms of action, and identify subgroups amenable to treatment.

Assessment of anxiety in children and adolescents: A comparative study on the validity and reliability of the Spence Children's Anxiety Scale in children and adolescents with anxiety and Autism Spectrum Disorder.

OBJECTIVE: The present study assessed the utility of the Spence Children's Anxiety Scale - Parent Form (SCAS-P) across parents of children with (i) anxiety and (ii) Autism Spectrum Disorder (ASD). METHOD: Parents of children aged 7-18 years with anxiety or ASD completed the SCAS-P. Multiple indicator multiple cause (MIMIC) structural equation modelling was utilized to analyse the data. RESULTS: Analysis revealed different factor structures between the Anxious and ASD groups and evidence for measurement variance across groups in some parts of the SCAS-P. CONCLUSION: Results on the SCAS-P in children with ASD need to be interpreted with caution. Some SCAS-P items cannot be interpreted in the same way in an ASD population compared to neurotypical children with anxiety.

Protocol for the Inroads Study: A Randomized Controlled Trial of an Internet-Delivered, Cognitive Behavioral Therapy-Based Early Intervention to Reduce Anxiety and Hazardous Alcohol Use Among Young People.

BACKGROUND: The transition to adulthood is a unique developmental period characterized by numerous personal and social role changes and increased opportunities for alcohol consumption. Using alcohol to cope with anxiety symptoms is commonly reported, and young people with anxiety are at a greater risk of hazardous alcohol use and progression to alcohol use disorder. Anxiety and alcohol use tend to fuel each other in an exacerbating feed-forward cycle, leading to difficult-to-treat chronic problems. The peak in onset of anxiety and alcohol disorders suggests this developmental window represents a promising opportunity for early intervention before these problems become entrenched. OBJECTIVE: This study aims to evaluate the efficacy of the Inroads program, a therapist-supported, internet-delivered early intervention for young adults that targets alcohol use, anxiety symptoms, and the interconnections between these problems. METHODS: A randomized controlled trial will be conducted nationally among young Australians (aged 17-24 years) who experience anxiety symptoms and drink alcohol at hazardous or harmful levels. Participants will be individually randomized on a 1:1 basis to receive the Inroads intervention or assessment plus alcohol guidelines. Participants randomized to the Inroads intervention will receive access to 5 Web-based cognitive behavioral therapy (CBT) modules and weekly therapist support via email and/or phone. The primary outcome assessment will be 8 weeks post baseline, with follow-up assessment 6 months post baseline to determine the sustainability of the intervention effects. Primary outcomes will be the total number of standard drinks consumed in the past month (assessed by the Timeline Follow-Back procedure), severity of alcohol-related harms (assessed by the Brief Young Adult Alcohol Consequences Questionnaire), and anxiety symptoms across multiple disorders (assessed by the Generalized Anxiety Disorder-7). Secondary outcomes will include alcohol outcome expectancies; functional impairment and quality of life; and symptoms of social anxiety, anxious arousal, and depression. Results will be analyzed by intention-to-treat using multilevel mixed effects analysis for repeated measures. RESULTS: The study is funded from 2017 to 2020 by Australian Rotary Health. Recruitment is expected to be complete by late-2018, with the 6-month follow-ups to be completed by mid-2019. Results are expected to be published in 2020. CONCLUSIONS: The study will be the first to evaluate the benefits of a youth-focused early intervention that simultaneously targets anxiety and hazardous alcohol use. By explicitly addressing the interconnections between anxiety and alcohol use and enhancing CBT coping skills, the Inroads program has the potential to interrupt the trajectory toward co-occurring anxiety and alcohol use disorders. The Web-based format of the program combined with minimal therapist support means that if effective, the program could be widely disseminated to reach young people who are not currently able or willing to access face-to-face treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617001609347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372748&isReview=true (Archived by WebCite at http://www.webcitation.org/77Au19jmf). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12370.