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Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting. We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 (95% CI: -0.59, -0.40) for depression, -0.43 (95% CI: -0.51, -0.35) for PTS, -0.42 (95% CI: -0.58, -0.27) for functional impairment, -0.48 (95% CI: -0.61, -0.34) for anxiety, -0.24 (95% CI: -0.34, -0.15) for aggression, and -0.03 (95% CI: -0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention. CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs. ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary.

Despite established clinical associations among major depression (MD), alcohol dependence (AD), and alcohol consumption (AC), the nature of the causal relationship between them is not completely understood. We leveraged genome-wide data from the Psychiatric Genomics Consortium (PGC) and UK Biobank to test for the presence of shared genetic mechanisms and causal relationships among MD, AD, and AC. Linkage disequilibrium score regression and Mendelian randomization (MR) were performed using genome-wide data from the PGC (MD: 135 458 cases and 344 901 controls; AD: 10 206 cases and 28 480 controls) and UK Biobank (AC-frequency: 438 308 individuals; AC-quantity: 307 098 individuals). Positive genetic correlation was observed between MD and AD (rgMD-AD = + 0.47, P = 6.6 × 10-10). AC-quantity showed positive genetic correlation with both AD (rgAD-AC quantity = + 0.75, P = 1.8 × 10-14) and MD (rgMD-AC quantity = + 0.14, P = 2.9 × 10-7), while there was negative correlation of AC-frequency with MD (rgMD-AC frequency = -0.17, P = 1.5 × 10-10) and a non-significant result with AD. MR analyses confirmed the presence of pleiotropy among these four traits. However, the MD-AD results reflect a mediated-pleiotropy mechanism (i.e. causal relationship) with an effect of MD on AD (beta = 0.28, P = 1.29 × 10-6). There was no evidence for reverse causation. This study supports a causal role for genetic liability of MD on AD based on genetic datasets including thousands of individuals. Understanding mechanisms underlying MD-AD comorbidity addresses important public health concerns and has the potential to facilitate prevention and intervention efforts.

Randomized trials of medications for alcohol dependence (AD) often report no differences between active medications. Few studies in AD have tested hypotheses regarding which medication will work best for which patients (ie, precision medicine). The PREDICT study tested acamprosate and naltrexone vs placebo in 426 randomly assigned AD patients in a 3-month treatment. PREDICT proposed individuals whose drinking was driven by positive reinforcement (ie, reward drinkers) would have a better treatment response to naltrexone, whereas individuals whose drinking was driven by negative reinforcement (ie, relief drinkers) would have a better treatment response to acamprosate. The goal of the current analysis was to test this precision medicine hypothesis of the PREDICT study via analyses of subgroups. Results indicated that four phenotypes could be derived using the Inventory of Drinking Situations, a 30-item self-report questionnaire. These were high reward/high relief, high reward/low relief, low reward/high relief, and low reward/low relief phenotypes. Construct validation analyses provided strong support for the validity of these phenotypes. The subgroup of individuals who were predominantly reward drinkers and received naltrexone vs placebo had an 83% reduction in the likelihood of any heavy drinking (large effect size). Cutoff analyses were done for clinical applicability: individuals are reward drinkers and respond to naltrexone if their reward score was higher than their relief score AND their reward score was between 12 and 31. Using naltrexone with individuals who are predominantly reward drinkers produces significantly higher effect sizes than prescribing the medication to a more heterogeneous sample.

AbstractObjectiveTo evaluate the effectiveness of a doctor delivered screening and ultra-brief intervention (<1 minute) compared with simplified assessment only for reducing alcohol intake among patients with hazardous drinking in primary care.DesignPragmatic cluster randomised controlled trial.Setting40 primary care clinics in Japan that did not provide routine screening and brief intervention for hazardous drinking or treatment or self-help groups for alcohol dependency.Participants1133 outpatients aged 20-74 years with hazardous drinking (AUDIT-C (alcohol use disorders identification test-consumption) scores ≥5 for men and ≥4 for women). Clinic clusters were allocated to a study arm using a computer generated random sequence. Participants and staff who collected participant reported outcomes remained blinded to assignment.InterventionsPrimary care clinics were randomised to ultra-brief intervention (21 clinics, 531 patients) or simplified assessment only (19 clinics, 602 patients) groups. The intervention group comprised screening with AUDIT-C followed by brief oral advice and an alcohol information leaflet delivered in <1 minute. The control group comprised simplified assessment with AUDIT-C only.Main outcome measuresThe primary outcome was total alcohol consumption in the four weeks preceding the 24 week follow-up. Secondary outcomes included total alcohol consumption in the four weeks preceding the 12 week follow-up, and readiness to change drinking behaviour, measured at 12 and 24 weeks.ResultsAt 24 weeks, the difference in total alcohol consumption between the ultra-brief intervention group (1046.9 g/4 weeks (g/4wk), 95% confidence interval (CI) 918.3 to 1175.4) and control group (1019.0 g/4wk, 893.5 to 1144.6) was 27.8 g/4wk (−149.7 to 205.4, P=0.75), with a Hedges’ g of 0.02 (95% CI −0.10 to 0.14). At 12 weeks, the difference in total alcohol consumption between the intervention group (1034.1 g/4wk, 919.6 to 1148.7) and control group (979.3 g/4wk, 866.1 to 1092.4) was 54.9 g/4wk (−104.1 to 213.9, P=0.49), with a Hedges’ g of 0.04 (−0.08 to 0.16).ConclusionThis trial found no evidence to support the effectiveness of a doctor delivered ultra-brief intervention for hazardous drinking compared with simplified assessment only in primary care in Japan.Trial registrationUMIN Clinical Trials Registry UMIN000051388.

Background Ukraine has experienced armed conflict since 2014, with significant escalation in 2022. Since then, an estimated 3.7 million people have been internally displaced. Alcohol misuse remains a substantial public health challenge in Ukraine, with high levels of psychological distress among the displaced population. The current study aims to evaluate the effectiveness and cost-effectiveness of a transdiagnostic intervention (CHANGE) to address alcohol misuse and psychological distress through problem-solving therapy and selected behavioural strategies for managing alcohol misuse. We hypothesize that CHANGE, together with enhanced usual care (EUC), will be more effective in increasing the percentage of days abstinent (PDA) than EUC alone. Methods This study is a parallel-arm, single-blind, individually randomised controlled trial across Ukraine government-controlled territories. Following informed consent, we will recruit 500 adult war-affected men, randomised 1:1 to EUC and CHANGE, or EUC alone. Inclusion criteria include elevated levels of alcohol use (between 8 and 19, inclusive, on the Alcohol Use Disorder Identification Test); psychological distress (≥ 16 on the Kessler Psychological Distress Scale) and ability to speak Ukrainian or Russian. CHANGE will be delivered over 6 weeks by 14 community-based facilitators, with outcomes assessed at 3 months post-randomisation. The primary outcome for CHANGE is the PDA from alcohol at 3 months, measured using the Timeline Follow Back. Secondary outcomes include percentage days of heavy drinking, alcohol misuse, psychological distress (depression, anxiety, and posttraumatic stress disorder), functional disability, intimate partner violence perpetration and health economics indicators at 3 months. The primary analysis will follow an intention-to-treat approach. A mixed-methods process evaluation will examine facilitator competency, recruitment, retention/completion, appropriateness, dose received, fidelity and feasibility of delivery and acceptability. Discussion CHANGE is the first intervention aiming to address alcohol misuse and psychological distress in an active conflict setting. Trial registration ISRCTN14881856. Registered on 5th of July 2024.

Background The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. Discussion CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. Trial registration ISRCTN ISRCTN10360385. Registered on 30 January 2023.

BACKGROUNDThere is limited data on the extent to which indicated alcohol interventions are delivered in U.S. ambulatory care settings.OBJECTIVETo assess the receipt of alcohol-related services, including assessment of use, advice to reduce drinking, and information about alcohol treatment, during ambulatory care visits.DESIGNSecondary data analysis of the 2013 National Survey on Drug Use and Health, a cross-sectional, nationally representative survey of civilians in the non-institutionalized U.S. general population (response rate 71.7 %).PARTICIPANTSAdult ambulatory care users in the public use data file who did not obtain emergency or inpatient services (n = 17,266).MAIN MEASURESMeasurements included respondents’ alcohol consumption, heavy episodic drinking, alcohol use disorder, healthcare use, and receipt of alcohol-related interventions.KEY RESULTSApproximately 71.1 % of ambulatory care users received an alcohol assessment. Among past-month heavy episodic drinkers without an alcohol use disorder who reported receiving an alcohol assessment, 4.4 % were advised to cut back. Among individuals with alcohol abuse and alcohol dependence who reported receiving an alcohol assessment, 2.9 % and 7.0 %, respectively, were offered information about treatment.CONCLUSIONSRates of alcohol screening and assessment were relatively high among adults who attended healthcare visits, but rates of intervention were low, even when individuals were assessed for use. Efforts are needed to expand delivery of interventions when patients are identified as positive for risky drinking, hazardous alcohol use, and alcohol use disorders during ambulatory care visits.

Background While Aboriginal and Torres Strait Islander Australians are less likely to drink any alcohol than other Australians, those who drink are more likely to experience adverse alcohol-related health consequences. In a previous study, providing Aboriginal Community Controlled Health Services (ACCHSs) with training and support increased the odds of clients receiving AUDIT-C alcohol screening. A follow-up study found that these results were maintained for at least two years, but there was large variability in the effectiveness of the intervention between services. In this study, we use services that previously received support as a comparison group to test whether training and support can improve alcohol screening and brief intervention rates among wait-list control ACCHSs. Methods Design: Cluster randomised trial using routinely collected health data. Setting: Australia. Cases: Twenty-two ACCHSs that see at least 1000 clients a year and use Communicare as their practice management software. Intervention and comparator: After initiating support, we compare changes in screening and brief intervention between wait-list control services and services that had previously received support. Measurement: Records of AUDIT-C screening and brief intervention activity in routinely collected data. Results During the reference period we observed 357,257 instances where one of 74,568 clients attended services at least once during a two-monthly data extraction period. Following the start of support, the odds of screening (OR = 0.94 [95% CI 0.67, 1.32], p  = 0.74, 0.002) and brief intervention (OR = 1.43 [95% CI 0.69, 2.95], p = 0.34, 0.002) did not improve for the wait-list control group, relative to comparison services. Conclusions We did not replicate the finding that support and training improves AUDIT-C screening rates with wait-list control data. The benefits of support are likely context dependent. Coincidental policy changes may have sensitised services to the effects of support in the earlier phase of the study. Then the COVID-19 pandemic may have made services less open to change in this latest phase. Future efforts could include practice software prompts to alcohol screening and brief intervention, which are less reliant on individual staff time or resources. Trial registration Retrospectively registered on 2018-11-21: ACTRN12618001892202.

ABSTRACT BACKGROUND Alcohol use disorder is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments, few individuals with an alcohol use disorder are actively engaged in treatment. Available evidence suggests that primary care may play a crucial role in the identification of patients with an alcohol use disorder, delivery of interventions, and the success of treatment. OBJECTIVE The principal aims of this study were to test the effectiveness of a primary care-based Alcohol Care Management (ACM) program for alcohol use disorder and treatment engagement in veterans. DESIGN The design of the study was a 26-week single-blind randomized clinical trial. The study was conducted in the primary care practices at three VA medical centers. Participants were randomly assigned to treatment in ACM or standard treatment in a specialty outpatient addiction treatment program. PARTICIPANTS One hundred and sixty-three alcohol-dependent veterans were randomized. INTERVENTION ACM focused on the use of pharmacotherapy and psychosocial support. ACM was delivered in-person or by telephone within the primary care clinic. MAIN MEASUREMENTS Engagement in treatment and heavy alcohol consumption. KEY RESULTS The ACM condition had a significantly higher proportion of participants engaged in treatment over the 26 weeks [OR = 5.36, 95 % CI = (2.99, 9.59)]. The percentage of heavy drinking days were significantly lower in the ACM condition [OR = 2.16, 95 % CI = (1.27, 3.66)], while overall abstinence did not differ between groups. CONCLUSIONS Results demonstrate that treatment for an alcohol use disorder can be delivered effectively within primary care, leading to greater rates of engagement in treatment and greater reductions in heavy drinking.

Background Traumatic events are associated with alcohol use problems with increased alcohol craving as a potential mediator. There is still a lack of knowledge regarding the causal nature of this association and its underlying mechanisms. This study investigated the effects of acute trauma exposure on alcohol craving in healthy individuals considering the role of stress reactivity and childhood trauma (CT) using a laboratory randomized controlled design. Methods Ninety-five healthy participants were randomly exposed to a trauma or a neutral film. History of CT, and pre- to post-film changes in craving (craving reactivity, CR), anxiety, skin conductance, heart rate, and saliva cortisol levels were assessed. Moreover, associations between trauma film exposure and CR, the moderating role of CT, and associations between CT, stress reactivity, and trauma-induced CR were analyzed. Results Relative to the neutral film, the trauma film elicited an increase in CR in females but not in males. In males but not in females, the association between trauma film exposure and CR was moderated by CT, with trauma-induced CR increasing with the number of CT. In males, CT was related to decreased cortisol reactivity and increased heart rate and skin conductance response of which skin conductance was also associated with CR. Discussion These findings provide further evidence for a causal link between traumatic experiences and CR. While this association seems to be stronger in females, males might still be at risk in case of other vulnerability factors such as CT, with altered sympathetic stress reactivity as a potential contributing mechanism.