Search

Aims Among individuals with alcohol use disorder (AUD), sleep disturbances are pervasive and contribute to the etiology and maintenance of AUD. However, despite increased attention toward the relationship between alcohol use and sleep, limited empirical research has systematically examined whether reductions in drinking during treatment for AUD are associated with improvements in sleep problems. Methods We used data from a multisite, randomized, controlled trial that compared 6 months of treatment with gabapentin enacarbil extended-release with placebo for adults with moderate-to-severe AUD (N  = 346). The Timeline Follow-back was used to assess WHO risk drinking level reductions and the Pittsburgh Sleep Quality Index was used to assess sleep quality over the prior month at baseline and the end of treatment. Results Sleep problem scores in the active medication and placebo groups improved equally. Fewer sleep problems were noted among individuals who achieved at least a 1-level reduction (B  = −0.99, 95% confidence interval (CI) [−1.77, −0.20], P  = .014) or at least a 2-level reduction (B  = −0.80, 95% CI [−1.47, −0.14], P  = .018) in WHO risk drinking levels at the end of treatment. Reductions in drinking, with abstainers excluded from the analysis, also predicted fewer sleep problems at the end of treatment (1-level: B  = −1.01, 95% CI [−1.83, −0.20], P  = .015; 2-level: B  = −0.90, 95% CI [−1.59, −0.22], P  = .010). Conclusions Drinking reductions, including those short of abstinence, are associated with improvements in sleep problems during treatment for AUD. Additional assessment of the causal relationships between harm-reduction approaches to AUD and improvements in sleep is warranted. [ABSTRACT FROM AUTHOR]

Background: Abstinence has historically been considered the preferred goal of alcohol use disorder (AUD) treatment. However, most individuals with AUD do not want to abstain and many are able to reduce their drinking successfully. Craving is often a target of pharmacological and behavioral interventions for AUD, and reductions in craving may signal recovery. Whether reductions in drinking during AUD treatment are associated with reductions in craving has not been well examined. Methods: We conducted secondary analyses of data from three AUD clinical trials (N's= 1327, 346, and 200). Drinking reductions from baseline to the end of treatment were measured as changes in World Health Organization (WHO) risk drinking levels; alcohol craving was measured using validated self‐report measures. Regression analyses tested whether drinking reductions were associated with end‐of‐treatment craving reductions; moderation analyses tested whether associations between drinking reduction and end‐of‐treatment craving differed across AUD severity. Results: Reductions of at least 1 or at least 2 WHO risk drinking levels were associated with lower craving (all p's < 0.05). Results were substantively similar after removing abstainers at the end‐of‐treatment. Associations between drinking reductions and craving were generally not moderated by AUD severity. Conclusions: Individuals with WHO risk drinking level reductions reported significantly lower craving, as compared to those who did not achieve meaningful reductions in drinking. The results demonstrate the utility of WHO risk drinking levels as AUD clinical trial endpoints and provide evidence that drinking reductions mitigate craving. [ABSTRACT FROM AUTHOR]

Background: The Alcohol Use Disorders Identification Test‐Consumption (AUDIT‐C) is a three‐item screening measure of unhealthy alcohol use that is widely used in healthcare settings. Evidence shows high test–retest reliability of the AUDIT‐C in research samples, but most studies had limited external validity and used small samples that could not be used to evaluate reliability across demographic subgroups and/or screening modalities. This study evaluates the test–retest reliability of the AUDIT‐C completed in routine care in a large primary care sample, including across demographic subgroups defined by age, sex, race, ethnicity, and screening modality (i.e., completed in‐clinic or online). Methods: We used electronic health record (EHR) data from Kaiser Permanente Washington. The sample included 18,491 adult primary care patients who completed two AUDIT‐C screens 1–21 days apart as part of routine care in 2021. Test–retest reliability was evaluated for AUDIT‐C total scores (0–12) and for a binary measure indicating unhealthy alcohol use (scores ≥3 women, ≥4 men). Using previously established cutoffs, we interpreted reliability coefficients >0.75 as indicating "excellent" reliability. Results: AUDIT‐C screens completed in routine care and documented in EHRs had excellent test–retest reliability for total scores (ICC = 0.87, 95% CI: 0.87–0.87) and the binary indicator of unhealthy alcohol use (κ = 0.79, 95% CI: 0.78–0.80). Reliability coefficients were good to excellent across all demographic groups and for in‐clinic and online modalities. Higher reliability was seen when both screens were completed through online patient portals (ICC = 0.93, 95% CI: 0.93–0.93) versus in‐clinic (ICC = 0.81, 95% CI: 0.79–0.82) or when one screen was completed using each modality (ICC = 0.83, 95% CI: 0.82–0.83). Lower reliability was seen in American Indian/Alaska Native (ICC = 0.82, 95% CI: 0.75–0.87) and multiracial individuals (ICC = 0.82, 95% 0.80–0.84). Conclusions: In real‐world routine care conditions, AUDIT‐C screens have excellent test–retest reliability across demographic subgroups and modalities (online and in‐clinic). Future research should examine why reliability varies slightly across modalities and demographic subgroups. [ABSTRACT FROM AUTHOR]

Background: In West Africa, healers greatly outnumber trained mental health professionals. People with serious mental illness (SMI) are often seen by healers in "prayer camps" where they may also experience human rights abuses. We developed "M&M," an 8-week-long dual-pronged intervention involving (1) a smartphone-delivered toolkit designed to expose healers to brief psychosocial interventions and encourage them to preserve human rights (M-Healer app), and (2) a visiting nurse who provides medications to their patients (Mobile Nurse). Objective: We examined the feasibility, acceptability, safety, and preliminary effectiveness of the M&M intervention in real-world prayer camp settings. Methods: We conducted a single-arm field trial of M&M with people with SMI and healers at a prayer camp in Ghana. Healers were provided smartphones with M-Healer installed and were trained by practice facilitators to use the digital toolkit. In parallel, a study nurse visited their prayer camp to administer medications to their patients. Clinical assessors administered study measures to participants with SMI at pretreatment (baseline), midtreatment (4 weeks) and post treatment (8 weeks). Results: Seventeen participants were enrolled and most (n=15, 88.3%) were retained. Participants had an average age of 44.3 (SD 13.9) years and 59% (n=10) of them were male. Fourteen (82%) participants had a diagnosis of schizophrenia and 2 (18%) were diagnosed with bipolar disorder. Four healers were trained to use M-Healer. On average, they self-initiated app use 31.9 (SD 28.9) times per week. Healers watched an average of 19.1 (SD 21.2) videos, responded to 1.5 (SD 2.4) prompts, and used the app for 5.3 (SD 2.7) days weekly. Pre-post analyses revealed a significant and clinically meaningful reduction in psychiatric symptom severity (Brief Psychiatric Rating Scale score range 52.3 to 30.9; Brief Symptom Inventory score range 76.4 to 27.9), psychological distress (Talbieh Brief Distress Inventory score range 37.7 to 16.9), shame (Other as Shamer Scale score range 41.9 to 28.5), and stigma (Brief Internalized Stigma of Mental Illness Scale score range 11.8 to 10.3). We recorded a significant reduction in days chained (1.6 to 0.5) and a promising trend for reduction in the days of forced fasting (2.6 to 0.0, P=.06). We did not identify significant pre-post changes in patient-reported working alliance with healers (Working Alliance Inventory), depressive symptom severity (Patient Health Questionnaire-9), quality of life (Lehman Quality of Life Interview for the Mentally Ill), beliefs about medication (Beliefs about Medications Questionnaire--General Harm subscale), or other human rights abuses. No major side effects, health and safety violations, or serious adverse events occurred over the course of the trial. Conclusions: The M&M intervention proved to be feasible, acceptable, safe, and clinically promising. Preliminary findings suggest that the M-Healer toolkit may have shifted healers' behaviors at the prayer camp so that they commit fewer human rights abuses. [ABSTRACT FROM AUTHOR]

Background: The Alcohol Use Disorders Identification Test‐Consumption version (AUDIT‐C) has been robustly validated as a point‐in‐time screen for unhealthy alcohol use, but less is known about the significance of changes in AUDIT‐C scores from routine screenings over time. Unhealthy alcohol use and depression commonly co‐occur, and changes in drinking often co‐occur with changes in depression symptoms. We assess the associations between changes in AUDIT‐C scores and changes in depression symptoms reported on brief screens completed in routine care. Methods: The study sample included 198,335 primary care patients who completed two AUDIT‐C screens 11 to 24 months apart and the Patient Health Questionnaire‐2 (PHQ‐2) depression screen on the same day as each AUDIT‐C. Both screening measures were completed as part of routine care within a large health system in Washington state. AUDIT‐C scores were categorized to reflect five drinking levels at both time points, resulting in 25 subgroups with different change patterns. For each of the 25 subgroups, within‐group changes in the prevalence of positive PHQ‐2 depression screens were characterized using risk ratios (RRs) and McNemar's tests. Results: Patient subgroups with increases in AUDIT‐C risk categories generally experienced increases in the prevalence of positive depression screens (RRs ranging from 0.95 to 2.00). Patient subgroups with decreases in AUDIT‐C risk categories generally experienced decreases in the prevalence of positive depression screens (RRs ranging from 0.52 to 1.01). Patient subgroups that did not have changes in AUDIT‐C risk categories experienced little or no change in the prevalence of positive depression screens (RRs ranging from 0.98 to 1.15). Conclusions: As hypothesized, changes in alcohol consumption reported on AUDIT‐C screens completed in routine care were associated with changes in depression screening results. Results support the validity and clinical utility of monitoring changes in AUDIT‐C scores over time as a meaningful measure of changes in drinking. [ABSTRACT FROM AUTHOR]

Objective: People living with severe mental illness are at increased risk of medical comorbidity as well as poverty, food insecurity, and inadequate social support in managing their mental and physical health conditions. Lack of access to sufficient food negatively affects a person's ability to manage health conditions, in particular diabetes, which is twice as common among people with severe mental illness as the general population. This study aimed to explore associations among food insecurity, social support, and psychiatric symptoms among adults with severe mental illness and diabetes. Method: A cross-sectional survey was conducted between January and May 2021 among adults (N = 156) with severe mental illness and type 2 diabetes who received primary care through a large academic health-care system (26% response rate). Valid and reliable questionnaires were implemented to measure food insecurity, social support, and mental health. Regression analysis was applied to examine the associations between food security status, social support, and mental health. Results: Food insecurity and social support are both correlated with psychiatric symptom severity. Specifically, support from family members has the largest protective role against food insecurity. Conclusions and Implications for Practice: This study found food insecurity is likely a critical issue to address whenever it is present in adults with severe mental illness (SMI) and type 2 diabetes. The presence of family support mitigates the need for addressing food insecurity. Practices and policies aimed at both addressing health inequities such as food insecurity and strengthening family support among people living with SMI and comorbid medical conditions are important adjuncts to self-management interventions. Impact and Implications: Medical care for diabetes for people who have SMI must address the impact of social determinants of health, including food insecurity and social support. For adults with SMI and type 2 diabetes, family support may have important effects on the link between food insecurity and adverse mental health outcomes. [ABSTRACT FROM AUTHOR]

Background Recently, the Food and Drug Administration ( FDA) proposed to expand the options for primary end points in the development of medications for alcohol use disorder to include either abstinence from alcohol or a nonabstinent outcome: no heavy drinking days (with a heavy drinking day defined as more than 3 drinks per day for women and more than 4 drinks per day for men [>3/>4 cutoff]). The FDA also suggested that 6 months would be the most appropriate length for a clinical trial to demonstrate the stability of this nonabstinent drinking outcome. However, few alcohol clinical trials have examined the stability of nonheavy drinking during and after treatment. Methods In a secondary analysis of the COMBINE study data ( n = 1,383), we examined transitions in heavy drinking days during the course of treatment (months 1 through 4), during the transition out of treatment (months 4 through 7), and up to 12 months afterward (months 13 through 16) using latent variable mixture models. Results Heavy drinking and nonheavy drinking were relatively stable in consecutive months (minimum agreement [kappa] = 0.64 for months 1 to 2). Most individuals were stable low-risk drinkers/abstainers or heavy drinkers by the end of treatment, as characterized by a 10% probability (or less) of transitioning out of either a no heavy drinking state or a heavy drinking state. More than two-thirds of the heavy drinkers who exceeded the heavy drinking threshold during treatment reported, on average, a 64% reduction in drinking frequency and a 38% reduction in drinking intensity from pretreatment drinking levels. Conclusions The results show stability of no heavy drinking as an outcome within the first 4 months of treatment and that the >3/>4 drink cutoff may mask substantial reductions in alcohol consumption among some patients. Future studies should explore the clinical utility of reduction end points. [ABSTRACT FROM AUTHOR]

Background Alcohol use disorder (AUD) is a highly prevalent public health problem associated with considerable individual and societal costs. Abstinence from alcohol is the most widely accepted target of treatment for AUD, but it severely limits treatment options and could deter individuals who prefer to reduce their drinking from seeking treatment. Clinical validation of reduced alcohol consumption as the primary outcome of alcohol clinical trials is critical for expanding treatment options. One potentially useful measure of alcohol treatment outcome is a reduction in the World Health Organization (WHO, International Guide for Monitoring Alcohol Consumption and Related Harm. Geneva, Switzerland, 2000) risk levels of alcohol use (very high risk, high risk, moderate risk, and low risk). For example, a 2-shift reduction in WHO risk levels (e.g., high risk to low risk) has been used by the European Medicines Agency (2010, Guideline on the Development of Medicinal Products for the Treatment of Alcohol Dependence. UK) to evaluate nalmefene as a treatment for alcohol dependence (AD; Mann et al. 2013, Biol Psychiatry 73, 706-13). Methods The current study was a secondary data analysis of the COMBINE study ( n = 1,383; Anton et al., ) to examine the association between reductions in WHO risk levels and reductions in alcohol-related consequences and mental health symptoms during and following treatment in patients with AD. Results Any reduction in WHO risk drinking level during treatment was associated with significantly fewer alcohol-related consequences and improved mental health at the end of treatment and for up to 1 year posttreatment. A greater reduction in WHO risk drinking level predicted a greater reduction in consequences and greater improvements in mental health. Conclusions Changes in WHO risk levels appear to be a valid end point for alcohol clinical trials. Based on the current findings, reductions in WHO risk drinking levels during treatment reflect meaningful reductions in alcohol-related consequences and improved functioning. [ABSTRACT FROM AUTHOR]

Background The construct of relapse is used widely in clinical research and practice of alcohol use disorder (AUD) treatment. The purpose of this study was to test the predictive validity of commonly appearing definitions of AUD relapse in the empirical literature. Methods Secondary analyses of data from Project MATCH and COMBINE were conducted using 7 definitions of 'relapse' based on drinking quantity within a single drinking episode: any drinking; at least 4/5 drinks for women/men; at least 4.3/7.1 drinks for women/men; at least 6/7 drinks for women/men; at least 6 drinks; at least 7/9 drinks for women/men; and at least 8/10 drinks for women/men. Relapse was used to predict alcohol consumption, related consequences, and nonconsumption outcomes (quality of life, psychosocial functioning) at the end of treatment and up to 1 year posttreatment. Results Regression analyses indicated within-treatment relapse definitions significantly predicted end-of-treatment alcohol consumption and alcohol-related consequences. Heavy drinking definitions were generally more predictive than the any drinking definition, but no single heavy drinking definition was consistently a better predictor of outcomes. Relapse definitions were less predictive of longer-term alcohol-related outcomes and both shorter- and longer-term nonconsumption outcomes, including health and psychosocial functioning. Conclusions One particular definition of relapse did not consistently stand out as the best predictor. Advances in AUD research may require reconceptualization of relapse as a multifaceted dynamic process and may consider a wider range of relevant behaviors (e.g., health and psychosocial functioning) when examining the change process in individuals with AUD. [ABSTRACT FROM AUTHOR]

Objective To assess color properties of white spot lesions (WSLs) following resin infiltration treatment in vitro. Materials and Method WSLs were artificially created on 30 extracted human teeth. Two groups were formed: (a) control, and (b) resin infiltrant group ( n = 15, each). Instrumental color measurements were performed using a spectrophotometer and visual color evaluation was performed by three independent evaluators. Color assessment was determined at three time points: baseline (T0), after WSL formation (T1), and after resin infiltrant or control treatment (T2). CIELAB color coordinates were determined and the resultant color difference (Δ E*) was calculated between the time points. Two-way repeated measures analysis of variance (ANOVA) and One-way ANOVA analyses were used to evaluate the color changes. Pearson chi-square analysis was performed to evaluate the visual ratings between treatment and control groups. Level of significance was set p <0.05. Results After treatment of WSLs there was a significant color change (Δ E*) between treatment and control groups ( p <0.05). Resin infiltration group showed a regression of all values toward the pretreatment levels. There was a significant difference in visual evaluation ratings between groups after treatment; treatment group had all surfaces receive a rating of being clinically acceptable, with 73% of these surfaces having no perceptible color difference to adjacent sound enamel. Meanwhile, control group received ratings of all surfaces having a visual color difference that was deemed as unacceptable ( p < 0.05). Conclusion In-vitro resin infiltration for the treatment of enamel WSLs produced a significant improvement in color, reverting L*, a*, and b* values back toward baseline values. Clinical Significance Resin infiltration of enamel white spot lesions on teeth is capable of managing the esthetic problem by reverting the L*, a*, and b* color coordinates back to their baseline values. (J Esthet Restor Dent 28:339-346, 2016) [ABSTRACT FROM AUTHOR]

Background: Missing data are common in alcohol clinical trials for both continuous and binary end points. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). This study compares approaches to modeling binary outcomes with missing data in the COMBINE study. Methods: We included participants in the COMBINE study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N = 1,146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using 4 analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst case scenario (WCS) of missing equals any drinking or heavy drinking, and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. Results: WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Conclusions: Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. [ABSTRACT FROM AUTHOR]

Background: Behavioral economic theories of drinking posit that the reinforcing value of engaging in activities with versus without alcohol influences drinking behavior. Measures of the reinforcement value of drugs and alcohol have been used in previous research, but little work has examined the psychometric properties of these measures.Objectives: The present study aims to evaluate the factor structure, test–retest reliability, and concurrent validity of an alcohol-only version of the Adolescent Reinforcement Survey Schedule (ARSS-AUV).Methods: A sample of 157 college student drinkers completed the ARSS-AUV at two time points 2–3 days apart. Test–retest reliability, hierarchical factor analysis, and correlations with other drinking measures were examined.Results: Single, unidimensional general factors accounted for a majority of the variance in alcohol and alcohol-free reinforcement items. Residual factors emerged that typically represented alcohol or alcohol-free reinforcement while doing activities with friends, romantic or sexual partners, and family members. Individual ARSS-AUV items had fair-to-good test–retest reliability, while general and residual factors had excellent test–retest reliability. General alcohol reinforcement and alcohol reinforcement from friends and romantic partners were positively correlated with past-year alcohol consumption, heaviest drinking episode, and alcohol-related negative consequences. Alcohol-free reinforcement indices were unrelated to alcohol use or consequences.Conclusions/Importance: The ARSS-AUV appears to demonstrate good reliability and mixed concurrent validity among college student drinkers. The instrument may provide useful information about alcohol reinforcement from various activities and people and could provide clinically-relevant information for prevention and treatment programs. [ABSTRACT FROM PUBLISHER]

Background and aims Drinking urges during treatment for alcohol use disorders (AUDs) are common, can cause distress and predict relapse. Clients may have little awareness of how their drinking urges might be expected to change during AUD treatment in general and in response to initiating abstinence. The aim of the present study was to test whether drinking urges change on a daily level during treatment and after initiating abstinence. Design Secondary data analysis was performed using daily drinking urge ratings from two randomized clinical trials. Setting and Participants Women ( n = 98) and men ( n = 79) with AUDs in separate clinical trials of out-patient AUD-focused cognitive-behavioral therapy. Measurements Daily dichotomous indicators of any drinking urges or acute escalations in urges (i.e. at least two more urges compared with the previous day) were examined using generalized linear mixed growth-curve modeling. Findings Participants who initiated abstinence reported reductions in urges immediately thereafter (log odds ratios: women B = −0.701, P < 0.001; men B = −0.628, P = 0.018), followed by additional, gradual reductions over time (women B = −0.118, P < 0.001; men B = −0.141, P < 0.001). Participants who entered treatment abstaining from alcohol also reported significant reductions in urges over time (women B = −0.147, P < 0.001; men B = −0.142, P < 0.001). Participants who drank throughout treatment had smaller (women B = −0.042, P = 0.012) or no reductions in urges (men B = 0.015, P = 0.545). There was no evidence that urges increased systematically in response to initiating abstinence. Conclusions Drinking urges during out-patient behavioral treatment for alcohol use disorders may be maintained in part by alcohol consumption. Initiating abstinence is associated with reductions in drinking urges immediately and then more gradually over time. [ABSTRACT FROM AUTHOR]

Couple-based treatments for alcohol use disorders ( AUDs) produce higher rates of abstinence than individual-based treatments and posit that active involvement of both identified patients ( IPs) and significant others ( SOs) is partly responsible for these improvements. Separate research on couples' communication has suggested that pronoun usage can indicate a communal approach to coping with health-related problems. The present study tested whether communal coping, indicated by use of more first-person plural pronouns ('we' language), fewer second-person pronouns ('you' language), and fewer first-person singular pronouns ('I' language), predicted improvements in abstinence in couple-based AUD treatment. Pronoun use was measured in first- and mid-treatment sessions for 188 heterosexual couples in four clinical trials of alcohol behavioral couple therapy ( ABCT). Percentages of days abstinent were assessed during treatment and over a 6-month follow-up period. Greater IP and SO 'we' language during both sessions was correlated with greater improvement in abstinent days during treatment. Greater SO 'we' language during first- and mid-treatment sessions was correlated with greater improvement in abstinence at follow-up. Greater use of IP and SO 'you' and 'I' language had mixed correlations with abstinence, typically being unrelated to or predicting less improvement in abstinence. When all pronoun variables were entered into regression models, only greater IP 'we' langue and lower IP 'you' language predicted improvements in abstinence during treatment, and only SO 'we' language predicted improvements during follow-up. Most pronoun categories had little or no association with baseline relationship distress. Results suggest that communal coping predicts better abstinence outcomes in couple-based AUD treatment. [ABSTRACT FROM AUTHOR]

Individuals receiving treatment for alcohol use disorders (AUDs) often experience urges to drink, and reductions in drinking urges during cognitive-behavioral therapy (CBT) predict better treatment outcomes. However, little previous work has examined patterns of daily drinking urges during treatment. This study examined patterns of change in daily drinking urges among participants in two randomized clinical trials of males (N =80 with 4,401 daily recordings) and females (N =101 with 8,011 daily recordings) receiving individual- or couples-based CBT. Drinking urges were common during treatment, occurring on 45.1% of days for men and 44.8% for women. Drinking urges and alcohol use for both genders decreased substantially during the course of treatment. Both genders had increases in drinking urges as more time elapsed since attending a treatment session. For men, this increase was most pronounced at the beginning of treatment, but for women it was most pronounced near the end of treatment. Alcohol use and drinking urges were both more likely to occur on weekends. The results suggest that these times may lead to higher risk for drinking, and clients may benefit from high-risk planning that is focused on these times. [ABSTRACT FROM AUTHOR]

Background Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem. In the absence of a simulation study, the drinking outcomes among those who are lost to follow-up are not known. Individuals who drop out of treatment and continue to provide drinking data, however, may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up. Methods We used data from the COMBINE study, a multisite, randomized clinical trial, to examine drinking during the 4 months of treatment among individuals who dropped out of treatment but continued to provide drinking data (i.e., 'treatment dropouts;' n = 185). First, we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = 961) and treatment dropouts ( n = 185; total N = 1,146), as well as the observed treatment effect size among just those who dropped out of treatment ( n = 185). In both the total sample ( N = 1,146) and the dropout sample ( n = 185), we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data. Using the deleted data sets, we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using 6 methods to handle missing data (last observation carried forward, baseline observation carried forward, placebo mean imputation, missing = heavy drinking days, multiple imputation ( MI), and full information maximum likelihood [ FIML]). Results MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses, while missing = heavy drinking days performed the worst. Conclusions Although missing drinking data should be avoided whenever possible, MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial. [ABSTRACT FROM AUTHOR]

Background The rate of participant attrition in alcohol clinical trials is often substantial and can cause significant issues with regard to the handling of missing data in statistical analyses of treatment effects. It is common for researchers to assume that missing data is indicative of participant relapse, and under that assumption, many researchers have relied on setting all missing values to the worst-case scenario for the outcome (e.g., missing = heavy drinking). This sort of single-imputation method has been criticized for producing biased results in other areas of clinical research, but has not been evaluated within the context of alcohol clinical trials, and many alcohol researchers continue to use the missing = heavy drinking assumption. Methods Data from the COMBINE study, a multisite randomized clinical trial, were used to generate simulated situations of missing data under a variety of conditions and assumptions. We manipulated the sample size ( n = 200, 500, and 1,000) and dropout rate (5, 10, 25, 30%) under 3 missing data assumptions (missing completely at random, missing at random, and missing not at random). We then examined the association between receiving naltrexone and heavy drinking during the first 10 weeks following treatment using 5 methods for treating missing data (complete case analysis [CCA], last observation carried forward [LOCF], missing = heavy drinking, multiple imputation [MI], and full information maximum likelihood [FIML]). Results CCA, LOCF, and missing = heavy drinking produced the most biased naltrexone effect estimates and standard errors under conditions that are likely to exist in randomized clinical trials. MI and FIML produced the least biased naltrexone effect estimates and standard errors. Conclusions Assuming that missing = heavy drinking produces biased results of the treatment effect and should not be used to evaluate treatment effects in alcohol clinical trials. [ABSTRACT FROM AUTHOR]

This study examined the association between relationship satisfaction and drinking urges among women who participated in alcohol behavioral individual therapy (ABIT) and Alcohol Behavioral Couples Therapy (ABCT). Relationship satisfaction and drinking urges were not related on a daily level, but urges were related to mean levels of relationship satisfaction, and this association was moderated by treatment condition and time in treatment. Women with higher relationship satisfaction had fewer drinking urges, and women in ABCT with higher relationship satisfaction experienced greater reductions in urges during treatment. These findings suggest that ABCT may target the association between relationship satisfaction and drinking urges. [ABSTRACT FROM PUBLISHER]

Objective: Practitioner attitudes regarding the nature of psychosis and prospects of recovery are important targets in supervision and training of practitioners who work therapeutically with this population. The 19-item Psychosis Attitudes Scale (PAS) was developed as a way to monitor changes in psychosis-related attitudes among practitioners being trained in an Evidence Based Treatment (EBT) for psychosis. This study reports the development and underlying factor structure of the PAS. Method: Three hundred twenty-five community mental health clinicians completed the PAS following a Cognitive Behavioral Therapy for psychosis (CBTp) multiday workshop training. We conducted an exploratory factor analysis to investigate the underlying structure of the initial set of items. Results: Our analyses suggest that the PAS taps into four attitude groupings, which can be conceptualized as perceived confidence in working with individuals with psychosis (Factor 1), a recovery orientation (Factor 2), expectations of fulfillment (Factor 3), and a stress-vulnerability orientation (Factor 4). Conclusions and Implications for Practice: Factors 1 and 3 appear to tap into general themes relevant to training practitioners in an evidence-based psychotherapeutic intervention for psychosis. Factors 2 and 4 are consistent with guiding principles of high-fidelity CBTp. At the individual level, practitioner attitudes have implications for training retention and treatment delivery. At the organizational level, the collective attitudes of staff in a given setting may serve as an indicator of readiness for EBT for psychosis implementation. Impact and Implications: The Psychosis Attitudes Scale (PAS) appears to tap into practitioner's self-confidence in working with individuals with psychosis, recovery orientation, expectations of professional fulfillment, and adoption of a stress-vulnerability framework for conceptualizing psychosis risk. As these themes are relevant to competent delivery of Cognitive Behavioral Therapy for psychosis (CBTp), the PAS appears to have utility as a process measure for training and supervising practitioners who work therapeutically with individuals with psychosis. [ABSTRACT FROM AUTHOR]

Co-occurring substance use disorders (SUDs) are common among people with opioid use disorder (OUD) and known to hinder receipt of medications for OUD (MOUD). It is important to understand how MOUD care implemented outside of SUD specialty settings impacts access for patients with co-occurring SUDs. The Veterans Health Administration's (VA) Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative was implemented in primary care, mental health, and pain clinics in 18 VA facilities, and was found to increase MOUD receipt. This study assessed the SCOUTT initiative's impact among patients with and without co-occurring SUDs. This study used a controlled interrupted time series design. We extracted electronic health record data for patients with OUD with visits in SCOUTT intervention or matched comparison clinics during the post-implementation year (9/1/2018–8/31/2019). We examined the monthly proportion of patients who received MOUD in SCOUTT intervention or comparison clinics (primary care, mental health, and pain clinics), or in a VA SUD specialty clinic (where patients may have been referred), during the pre- and post-implementation years. Segmented logistic regression models estimated pre-post changes in outcomes (immediate level change from the final month of the pre-implementation period to the first month of the post-implementation period, change in trend/slope) in intervention vs. comparison facilities, adjusting for patient characteristics and pre-implementation trends. We stratified analyses by the presence of co-occurring SUDs. Among patients without co-occurring SUDs, the pre-post trend/slope change in MOUD received in SCOUTT intervention or comparison clinics was greater in intervention vs. comparison facilities (adjusted odds ratio [aOR]: 1.06, 95% confidence interval [CI]: 1.02–1.10), and the immediate increase in MOUD received in SUD clinics was greater in intervention vs. comparison facilities (aOR: 1.12, 95% CI: 1.02–1.22). These changes did not significantly differ in intervention vs. comparison facilities among patients with co-occurring SUDs. The SCOUTT initiative may have increased MOUD receipt primarily among patients without co-occurring SUDs. Focusing on increasing MOUD receipt for patients with co-occurring SUDs may improve the overall effectiveness of MOUD implementation efforts. • SCOUTT implemented MOUD in VA primary care, mental health, and pain clinics. • We examined SCOUTT's impact among patients with and without co-occurring SUD. • SCOUTT may have increased MOUD for patients without, but not with, co-occurring SUD. • MOUD implementation efforts should increase focus on patients with co-occurring SUD. [ABSTRACT FROM AUTHOR]