Cognitive processing therapy (CPT) versus individual drug counseling (IDC) for PTSD for veterans with opioid use disorder maintained on buprenorphine.

BACKGROUND AND OBJECTIVES: There are high rates of comorbidity between posttraumatic stress disorder (PTSD) and opioid use disorder (OUD). Evidence-based trauma-focused psychotherapies such as Cognitive Processing Therapy (CPT) are a first-line treatment for PTSD. Veterans with OUD are treated primarily in substance use disorder (SUD) clinics where the standard of care is drug counseling; they often do not have access to first-line PTSD treatments. This study tested whether CPT can be conducted safely and effectively in veterans with comorbid OUD treated with buprenorphine. METHODS: This 12-week, 2-site, randomized clinical trial (RCT) included open-label randomization to two groups: (a) CPT versus (b) Individual Drug Counselling (IDC) in veterans with PTSD and comorbid OUD who were maintained on buprenorphine (N = 38). RESULTS: Veterans randomized to either IDC (n = 18) or CPT (n = 20) showed a significant reduction in self-reported PTSD symptoms over time as measured by the PTSD checklist (PCL-5) but there were no treatment group differences; there was some indication that reduction in PTSD symptoms in the CPT group were sustained in contrast to the IDC group. Recruitment was significantly impacted by COVID-19 pandemic, so this study serves as a proof-of-concept pilot study. DISCUSSION AND CONCLUSIONS: Veterans with OUD and PTSD can safely and effectively participate in evidence-based therapy for PTSD; further work should confirm that trauma-focused treatment may be more effective in leading to sustained remission of PTSD symptoms than drug counseling. SCIENTIFIC SIGNIFICANCE: This is the first study to evaluate CPT for PTSD in the context of buprenorphine treatment for OUD.

A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy.

BACKGROUND: Computer-based delivery of cognitive behavioral therapy (CBT) may be a less costly approach to increase dissemination and implementation of evidence-based treatments for alcohol use disorder (AUD). However, comprehensive evaluations of costs, cost-effectiveness, and cost-benefit of computer-delivered interventions are rare. METHODS: This study used data from a completed randomized clinical trial to evaluate the cost-effectiveness and cost-benefit of a computer-based version of CBT (CBT4CBT) for AUD. Sixty-three participants were randomized to receive one of the following treatments at an outpatient treatment facility and attended at least one session: (1) treatment as usual (TAU), (2) CBT4CBT plus treatment as usual (CBT4CBT+TAU), or (3) CBT4CBT plus brief monitoring. RESULTS: Median protocol treatment costs per participant differed significantly between conditions, Kruskal-Wallis H(2) = 8.40, p = 0.02, such that CBT4CBT+TAU and CBT4CBT+monitoring each cost significantly more per participant than TAU. However, when nonprotocol treatment costs were included, total treatment costs per participant did not differ significantly between conditions. Median incremental cost-effective ratios (ICERs) revealed that CBT4CBT+TAU was more costly and more effective than TAU. It cost $35.08 to add CBT4CBT to TAU to produce a reduction of one additional drinking day per month between baseline and the end of the 8-week treatment protocol: CBT4CBT+monitoring cost $33.70 less to produce a reduction of one additional drinking day per month because CBT4CBT+monitoring was less costly than TAU and more effective at treatment termination, though not significantly so. Net benefit analyses suggested that costs of treatment, regardless of condition, did not offset monthly costs related to healthcare utilization, criminal justice involvement, and employment disruption between baseline and 6-month follow-up. Benefit-cost ratios were similar for each condition. CONCLUSIONS: Results of this pilot economic evaluation suggest that an 8-week course of CBT4CBT may be a cost-effective addition and potential alternative to standard outpatient treatment for AUD. Additional research is needed to generate conclusions about the cost-benefit of providing CBT4CBT to treatment-seeking individuals participating in standard outpatient treatment.

Double-Blind Placebo-Controlled Trial of Galantamine for Methadone-Maintained Individuals With Cocaine Use Disorder: Secondary Analysis of Effects on Illicit Opioid Use.

BACKGROUND AND OBJECTIVES: Concurrent use of cocaine and opioids is a persistent and challenging problem, particularly within methadone maintenance settings, and there are no approved pharmacotherapies for this population. Galantamine, a cholinesterase inhibitor, was found in a randomized clinical trial to reduce cocaine use among methadone-maintained individuals who were also cocaine dependent. Because of the potential of galantamine to reduce multiple drugs of abuse, it may also reduce opioid use. METHODS: We conducted a secondary analysis of a randomized, double-blind, placebo-controlled trial of 120 methadone-maintained individuals with concurrent cocaine dependence. Participants were randomized to galantamine or placebo in a 12-week trial with a 6-month follow-up (97% of intention to treat sample reached for final follow-up). RESULTS: There was a significant main effect for galantamine over placebo on percent of urine specimens that were negative for opioids, both within treatment (77% for galantamine vs 62% for placebo, F = 5.0, P = 0.027) and through a 6-month follow-up (81% vs 59%, respectively, F = 10.8, P = 0.001). This effect was seen regardless of whether participants used nonprescribed opioids during the baseline period. Galantamine effects were seen early in treatment, with participants in placebo submitting the first opioid-positive urine specimen significantly sooner than participants in galantamine (median day 15 vs 53, Wilcoxon = 5.7, P = 0.02). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: If these results are supported in future trials, galantamine may hold promise across multiple drugs of abuse, including opioids. (Am J Addict 2019;28:238-245).

Culturally Adapted, Web-Based Cognitive Behavioral Therapy for Spanish-Speaking Individuals With Substance Use Disorders: A Randomized Clinical Trial.

OBJECTIVES: To evaluate whether adding Web-based cognitive behavioral treatment (CBT) to standard outpatient psychiatric or addiction treatment improved substance use outcomes. METHODS: We conducted a randomized clinical trial in New Haven, Connecticut, between 2014 and 2017 comparing 8 weeks of standard outpatient treatment to the same treatment with access to a culturally adapted version of Web-based CBT with a 6-month follow-up. Participants were 92 treatment-seeking individuals with Spanish as their primary language and current substance use disorder, with few other restrictions. RESULTS: Treatment completion and data availability were high (98% of the randomized sample). For the primary outcome (change in frequency of primary substance used), there was a significant effect of treatment condition by time (t 1, 718 = -2.64; 95% confidence interval = -0.61, 0.09; P = .01), indicating significantly greater reductions for those assigned to Web CBT, which were durable through the 6-month follow-up. The knowledge test indicated significantly greater increases for those assigned to Web CBT. CONCLUSIONS: Adding a culturally adapted version of Web-based CBT to standard treatment improved substance use outcomes. Public Health Implications. This approach has high potential to address health disparities by providing an easily accessible, inexpensive form of evidence-based treatment to a range of Latinos with substance use disorders.

Change in DSM-5 Alcohol Use Disorder Criteria Count and Severity Level as a Treatment Outcome Indicator: Results from a Randomized Trial.

BACKGROUND: Most clinical trials evaluating treatments for alcohol use target individuals meeting diagnostic criteria for alcohol use disorder (AUD), but few address change in diagnostic status following treatment or as a potential outcome indicator. This study evaluated whether DSM-5 AUD total criteria count or severity category was sensitive to change over time and treatment effects. METHODS: Data were drawn from a randomized clinical trial that evaluated the efficacy of computer-based cognitive behavioral therapy program (CBT4CBT) for AUD. Sixty-eight individuals were randomized to 1 of the 3 weekly outpatient treatments for an 8-week period: (i) treatment as usual (TAU), (ii) TAU+CBT4CBT, and (iii) CBT4CBT+brief monitoring. Structured clinical interviews were used to determine current (past 30 days) AUD diagnosis at baseline, end-of-treatment, and 6 months following end-of-treatment. Change in the total number of DSM criteria endorsed, as well as severity categories (mild, moderate, severe), was evaluated across time and by treatment condition. RESULTS: Generalized Poisson's linear mixed models revealed a significant reduction in the number of DSM criteria from baseline to treatment end point [time effect χ2 (1) = 35.54, p < 0.01], but no significant interactions between time and treatment condition. Fewer total criteria endorsed, as well as achieving at least a 2-level reduction in AUD severity category at end-of-treatment, were associated with better outcomes during follow-up. Chi-square results indicated a greater proportion of individuals assigned to TAU+CBT4CBT had at least a 2-level reduction in severity category compared to TAU, at trend-level significance [χ2 (2, 54) = 5.13, p = 0.07], consistent with primary alcohol use outcomes in the main trial. CONCLUSIONS: This is the first study to demonstrate change in DSM-5 AUD total criteria count, as well as severity category, in a randomized clinical trial. These findings offer support for their use as a potential clinically meaningful outcome indicator.

Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome.

BACKGROUND: Cognitive-behavior therapy (CBT) for substance use disorder is empirically supported, and may be associated with change in affect over time. OBJECTIVES: Understanding the role of affect in cocaine use disorder could help to improve CBT outcomes. METHODS: This secondary analysis included 140 adults with cocaine use disorder, 57.9% female, drawn from two randomized controlled studies of web-based cognitive-behavior therapy who completed the Positive and Negative Affect Scale (PANAS) before and during treatment. RESULTS: In mixed-effects regression models, baseline negative affect (NA) scores were not associated with self-reported cocaine use during treatment, but baseline PA scores were associated with less frequent cocaine use (ß = -0.04, p = .02). During treatment, NA scores reduced over time in CBT and treatment as usual (ß = -0.27, p < .01), although PA scores did not change. Higher weekly NA scores were associated with weekly cocaine use (ß = .02, SE = .01, t(746.15) = 2.37, p = .02), although weekly PANAS PA scores were not associated with weekly cocaine use. DISCUSSION AND CONCLUSIONS: Results indicated that individuals with higher baseline PA were more likely to abstain from cocaine use during treatment, even when controlling for baseline cocaine use frequency. Although baseline NA was not associated with cocaine use, NA during treatment was associated with greater cocaine use. SCIENTIFIC SIGNIFICANCE: PA at baseline and NA during treatment were associated with cocaine use. If findings are replicated, treatment developers may wish to include treatment interventions to boost early PA and reduce NA throughout treatment. (Am J Addict 2018;XX:1-8).

Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment.

BACKGROUND: Cognitive behavioral therapy (CBT) is an evidence-based treatment for alcohol use disorders (AUDs), yet is rarely implemented with high fidelity in clinical practice. Computer-based delivery of CBT offers the potential to address dissemination challenges, but to date there have been no evaluations of a web-based CBT program for alcohol use within a clinical sample. METHODS: This study randomized treatment-seeking individuals with a current AUD to 1 of 3 treatments at a community outpatient facility: (i) standard treatment as usual (TAU); (ii) TAU plus on-site access to a computerized CBT targeting alcohol use (TAU + CBT4CBT); or (iii) CBT4CBT plus brief weekly clinical monitoring (CBT4CBT + monitoring). Participant alcohol use was assessed weekly during an 8-week treatment period, as well as 1, 3, and 6 months after treatment. RESULTS: Sixty-eight individuals (65% male; 54% African American) were randomized (TAU = 22; TAU + CBT4CBT = 22; CBT4CBT + monitoring = 24). There were significantly higher rates of treatment completion among participants assigned to 1 of the CBT4CBT conditions compared to TAU (Wald = 6.86, p < 0.01). Significant reductions in alcohol use were found across all conditions within treatment, with participants assigned to TAU + CBT4CBT demonstrating greater increases in percentage of days abstinent (PDA) compared to TAU, t(536.4) = 2.68, p < 0.01, d = 0.71, 95% CI (0.60, 3.91), for the full sample. Preliminary findings suggest the estimated costs of all self-reported AUD-related services utilized by participants were considerably lower for those assigned to CBT4CBT conditions compared to TAU, both within treatment and during follow-up. CONCLUSIONS: This trial demonstrated the safety, feasibility, and preliminary efficacy of web-based CBT4CBT targeting alcohol use. CBT4CBT was superior to TAU at increasing PDA when delivered as an add-on, and it was not significantly different from TAU or TAU + CBT4CBT when delivered with clinical monitoring only.

Psychometric properties of the Positive and Negative Affect Schedule (PANAS) in a heterogeneous sample of substance users.

BACKGROUND: The Positive and Negative Affect Schedule (PANAS) is a widely used measure of affect. A comprehensive psychometric evaluation among substance users, however, has not been published. OBJECTIVE: To examine the psychometric properties of the PANAS in a sample of outpatient treatment substance users. METHODS: We used pooled data from four randomized clinical trials (N = 416; 34% female, 48% African American). RESULTS: A confirmatory factor analysis indicated adequate support for a two-factor correlated model comprised of Positive Affect and Negative Affect with correlated item errors (Comparative Fit Index = 0.93, Root Mean Square Error of Approximation = 0.07, χ(2) = 478.93, df = 156). Cronbach's α indicated excellent internal consistency for both factors (0.90 and 0.91, respectively). The PANAS factors had good convergence and discriminability (Composite Reliability > 0.7; Maximum Shared Variance < Average Variance Extracted). A comparison from baseline to Week 1 indicated acceptable test-retest reliability (Positive Affect = 0.80, Negative Affect = 0.76). Concurrent and discriminant validity were demonstrated with correlations with the Brief Symptom Inventory and Addiction Severity Index. The PANAS scores were also significantly correlated with treatment outcomes (e.g. Positive Affect was associated with the maximum days of consecutive abstinence from primary substance of abuse, r = 0.16, p = 0.001). CONCLUSION: Our data suggest that the psychometric properties of the PANAS are retained in substance using populations. Although several studies have focused on the role of Negative Affect, our findings suggest that Positive Affect may also be an important factor in substance use treatment outcomes.

Prompted to treatment by the criminal justice system: Relationships with treatment retention and outcome among cocaine users.

BACKGROUND AND OBJECTIVES: A substantial portion of individuals entering treatment for substance use have been referred by the criminal justice system, yet there are conflicting reports regarding treatment engagement and outcome differences compared to those not referred. This study examined baseline characteristic and treatment outcome differences among cocaine-dependent individuals participating in cocaine treatment randomized trials. METHODS: This secondary analysis pooled samples across five completed randomized controlled trials, resulting in 434 participants. Of these, 67 (15%) were prompted to treatment by the criminal justice system. RESULTS: This subsample of criminal justice prompted (CJP) individuals did not differ from those not prompted by the criminal justice system in terms of gender, race/ethnicity, marital status, or age. However, the CJP group reported more years of regular cocaine use, more severe employment and legal problems, as well as less readiness to change prior to treatment. Treatment outcomes did not differ significantly from those without a criminal justice prompt, and on some measures the outcomes for CJP group were better (e.g., percentage of days cocaine abstinent, number of therapy sessions attended). DISCUSSION AND CONCLUSIONS: These findings suggest that being prompted to treatment by the criminal justice system may not lead to poorer treatment engagement or substance use outcomes for individuals participating in randomized controlled treatment trials. SCIENTIFIC SIGNIFICANCE: Despite some baseline indicators of poorer treatment prognosis, individuals who have been prompted to treatment by the criminal justice system have similar treatment outcomes as those presenting to treatment voluntarily.

Assessment concordance and predictive validity of self-report and biological assay of cocaine use in treatment trials.

BACKGROUND AND OBJECTIVES: Cocaine use during randomized clinical trials (RCTs) is typically assessed by participant self-report or biological assay (eg, urinalysis). There have been few direct comparisons of these assessment methods to investigate their concordance and their predictive validity for cocaine use and psychosocial outcomes following treatment completion. METHOD: In a combined sample of 380 participants from 5 cocaine RCTs, the concordance between cocaine use assessment methods was examined. Sequential multiple linear and logistic regression models evaluated the predictive validity of two assessment methods for cocaine use and psychosocial outcomes assessed at 1, 3, 6, and 12 months after treatment. RESULTS: Concordance for self-report and urinalysis indicators of cocaine use was high within-treatment (k = 0.72) and moderate during follow-up (k = 0.51). Rates of concordance were higher in studies using test cups with immediate urinalysis results. Regression analyses indicated that self-report data within-treatment predicted self-reported cocaine use at all post-treatment points (ß 0.22-0.30, p < .01), while urinalysis results within-treatment predicted urinalysis results at 1, 3, and 6 months post-treatment (OR 3.92-20.99, p < .05). Cocaine-positive urinalyses within-treatment were negatively associated with a composite "good outcome" indicator at 1 and 3 months post-treatment (OR 0.17-0.32, p < .05). DISCUSSION AND CONCLUSIONS: These results suggest a significant role of method variance in predicting post-treatment outcomes from within-treatment cocaine use indices. SCIENTIFIC SIGNIFICANCE: Results support recommendations that cocaine treatment trials should include both biological assay and self-report assessment. Test cups may facilitate increased self-report accuracy.

Development of the Therapist Empathy Scale.

BACKGROUND: Few measures exist to examine therapist empathy as it occurs in session. AIMS: A 9-item observer rating scale, called the Therapist Empathy Scale (TES), was developed based on Watson's (1999) work to assess affective, cognitive, attitudinal, and attunement aspects of therapist empathy. The aim of this study was to evaluate the inter-rater reliability, internal consistency, and construct and criterion validity of the TES. METHOD: Raters evaluated therapist empathy in 315 client sessions conducted by 91 therapists, using data from a multi-site therapist training trial (Martino et al., 2010) in Motivational Interviewing (MI). RESULTS: Inter-rater reliability (ICC = .87 to .91) and internal consistency (Cronbach's alpha = .94) were high. Confirmatory factor analyses indicated some support for single-factor fit. Convergent validity was supported by correlations between TES scores and MI fundamental adherence (r range .50 to .67) and competence scores (r range .56 to .69). Discriminant validity was indicated by negative or nonsignificant correlations between TES and MI-inconsistent behavior (r range .05 to -.33). CONCLUSIONS: The TES demonstrates excellent inter-rater reliability and internal consistency. RESULTS indicate some support for a single-factor solution and convergent and discriminant validity. Future studies should examine the use of the TES to evaluate therapist empathy in different psychotherapy approaches and to determine the impact of therapist empathy on client outcome.

Structural brain changes associated with cocaine use and digital cognitive behavioral therapy in cocaine use disorder treatment.

Background: Few studies have investigated changes in brain structure and function associated with recovery from cocaine use disorder (CUD), and fewer still have identified brain changes associated with specific CUD treatments, which could inform treatment development and optimization. Methods: In this longitudinal study, T1-weighted magnetic resonance imaging scans were acquired from 41 methadone-maintained individuals with CUD (15 women) at the beginning of and after 12 weeks of outpatient treatment. As part of a larger randomized controlled trial, these participants were randomly assigned to receive (or not) computer-based training for cognitive behavioral therapy (CBT4CBT), and galantamine (or placebo). Results: Irrespective of treatment condition, whole-brain voxel-based morphometry analyses revealed a significant decrease in right caudate body, bilateral cerebellum, and right middle temporal gyrus gray matter volume (GMV) at post-treatment relative to the start of treatment. Subsequent region of interest analyses found that greater reductions in right caudate and bilateral cerebellar GMV were associated with higher relative and absolute levels of cocaine use during treatment, respectively. Participants who completed more CBT4CBT modules had a greater reduction in right middle temporal gyrus GMV. Conclusions: These results extend previous findings regarding changes in caudate and cerebellar GMV as a function of cocaine use and provide the first evidence of a change in brain structure as a function of engagement in digital CBT for addiction. These data suggest a novel potential mechanism underlying how CBT4CBT and CBT more broadly may exert therapeutic effects on substance-use-related behaviors through brain regions implicated in semantic knowledge.

Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment.

BACKGROUND: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. OBJECTIVE: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. METHODS: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. RESULTS: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. CONCLUSIONS: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54342.

Risk factors of violence during a 4-week period in a psychiatric outpatient population.

The clinical impact of structured risk assessment instruments has been limited by a lack of information regarding a) their short-term accuracy and b) the relationship between change as measured by the instrument and a change in the risk for harm. Data were collected every 4 weeks on a) variables designed to resemble the items of a structured risk assessment instrument, b) substance use, c) social circumstances and mental state, and d) violent behavior. Scores on the variables designed to resemble the items of a risk assessment instrument were associated with violence during the ensuing 4 weeks. However, an increase in a subject's score on these variables was not associated with violence. Instead, increasing cocaine use and increasing social conflict as described by the subject at interview were associated with violence during those weeks.

The rise and fall of substance use during treatment: Applying recency and expectancy principles to daily substance use patterns.

OBJECTIVE: Clinical trials for substance use disorder (SUD) often assess outcomes by aggregating substance use data into weekly proportions. However, daily substance use patterns may reveal how motivation changes during treatment. Neurocognitive principles of recency and expectancy indicate the salience of treatment mechanisms would increase on days proximal to therapy sessions. This study tested whether substance use decreased on days near treatment sessions. METHOD: Bayesian multilevel models were used in a secondary analysis of randomized clinical trial data comparing cognitive behavioral therapy (CBT), computerized CBT, and treatment as usual during outpatient SUD treatment (n = 94; 76% males; Mage = 38; 46% African American, 38% White, 6% multiracial, 10% other; 17% Hispanic). The number of days before/after a therapy session was used to predict daily substance use assessed by weekly self-reports. RESULTS: The models suggested that substance use increased as more days passed after a therapy session (b = 5.23) and then decelerated before the next therapy session (b² = -8.20). The evidence indicated that substance use was less likely on therapy days and the days after therapy. Primary drug type, SUD severity, and treatment condition moderated these findings. CONCLUSIONS: Substance use patterns during treatment were consistent with recency and expectancy neurocognitive principles. Substance use decreased on days closer to a therapy session, suggesting that treatment mechanisms were more salient on those days. More frequent therapeutic contact and targeted timing of treatment delivery may enhance treatment efficacy. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

The connection still matters: Therapeutic alliance with digital treatment for alcohol use disorder.

BACKGROUND: A strong cooperative bond between the patient and provider ("therapeutic alliance") is robustly associated with better alcohol use disorder (AUD) treatment outcomes. Although digital treatments for AUD have significant potential, the function of the alliance during digital programs is unclear. We compared the validity of patient-reported measures of the alliance with a digital treatment ("digital alliance") for AUD and the alliance with their clinician ("clinician alliance"). METHODS: We used data from an 8-week, randomized clinical trial of a computerized cognitive behavioral therapy program (CBT4CBT) during outpatient AUD treatment. Treatment conditions included CBT4CBT with minimal clinical monitoring (CBT4CBT + monitor) or with treatment as usual (CBT4CBT + TAU). The digital alliance and clinician alliance were measured with similar versions of the Working Alliance Inventory (WAI). The WAI ratings were completed at the 2nd and 6th treatment sessions. A timeline followback calendar assessed daily alcohol use. Bayesian multilevel models compared the strength of the alliances and tested their associations with future alcohol use. RESULTS: Data from 43 participants were included (age M = 44; 65% male; 51% Black, 40% White, 9% other; 14% Hispanic). The digital alliance ratings had similar internal reliability as the clinician alliance ratings (ω's > 0.90). Differences between digital alliance and clinician alliance ratings were negligible in both treatment conditions (BF01 = 9 and 31). During treatment, within-person increases in the digital alliance and the clinician alliance predicted modest decreases in future drinking to a similar degree (BF01 = 15). Alliance ratings were not associated with future drinking when posttreatment follow-up drinking data were included (BF10 < 3). CONCLUSIONS: The digital alliance with CBT4CBT was comparable to the clinician alliance. The digital alliance and clinician alliance had similar, albeit very small, associations with abstinence during treatment. Future research can explore how the digital alliance develops to improve AUD treatment efficacy.

Percentage of negative urine drug screens as a clinically meaningful endpoint for RCTs evaluating treatment for cocaine use.

BACKGROUND: This study examined a threshold based on the percentage of cocaine-negative (CN) urine drug screens (UDS) collected during treatment as a potential meaningful endpoint for clinical trials. We hypothesized that individuals providing at least 75% CN UDS would have better long-term outcomes than those providing less than 75% CN UDS. METHODS: Two separate pooled datasets of randomized clinical trials conducted at different institutions were used for analyses: one composed of eight trials (N = 760) and the other composed of three trials (N = 416), all evaluating behavioral and/or pharmacological treatments for cocaine use. UDS were collected at least once per week (up to three times per week) during the 8- or 12-week treatment period across all trials, with substance use and psychosocial functioning measured up to 12 months following treatment. Chi-squares and ANOVAs compared within-treatment and follow-up outcomes between the groups. RESULTS: Compared to those who did not achieve the threshold, participants who achieved the 75%-CN threshold were retained in treatment longer and had a longer period of continuous abstinence, and were more likely to report problem-free functioning. Additionally, participants who achieved the 75%-CN threshold were more likely to report sustained abstinence and better psychosocial functioning throughout a follow-up period up to 12 months than those who did not achieve the threshold. CONCLUSIONS: A threshold of 75%-CN UDS is associated with short- and long-term clinical benefits. Future clinical trials may consider this a meaningful threshold for defining treatment responders.

Breaking through social determinants of health: Results from a feasibility study of Imani Breakthrough, a community developed substance use intervention for Black and Latinx people.

Racial and ethnic disparities in substance use intervention design, implementation, and dissemination have been recognized for years, yet few intervention programs have been designed and conducted by and for people who use substances. Imani Breakthrough is a two-phase 22-week intervention developed by the community, run by facilitators with lived experience and church members, that is implemented in Black and Latinx church settings. This community-based participatory research (CBPR) approach is a concept developed in response to a call for action from the State of Connecticut Department of Mental Health and Addiction Services (DMHAS) with funding from the Substance Abuse and Mental Health Services Administration (SAMHSA) to address rising rates of death due to opioid overdose, and other negative consequences of substance misuse. After nine months of didactic community meetings, the final design involved twelve weeks of education in a group setting related to the recovery process, including the impact of trauma and racism on substance use, and a focus on citizenship and community participation and the 8 dimensions of wellness, followed by ten weeks of mutual support, with intensive wraparound support and life coaching focused on the social determinants of health (SDOH). We found the Imani intervention was feasible and acceptable, with 42 % of participants retained at 12 weeks. In addition, in a subset of participants with complete data, we found a significant increase in both citizenship scores and dimensions of wellness from baseline to week 12, with the greatest improvements in the occupational, intellectual, financial, and personal responsibility dimensions. As drug overdose rates among Black and Latinx people who use substances continue to increase, it is imperative that we address the inequities in the SDOH that contribute to this disparity gap so that we can develop interventions tailored to the specific needs of Black and Latinx people who use drugs. The Imani Breakthrough intervention shows promise as a community-driven approach that can address these disparities and promote health equity.

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population.

BACKGROUND: Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is unknown. We describe the rationale, aims, and protocol for Project ENHANCE (ENhancing Hospital-initiated Alcohol TreatmeNt to InCrease Engagement), a clinical trial testing increasingly intensive approaches using a hybrid type 1 effectiveness-implementation approach. METHODS: We are randomizing English and/or Spanish-speaking individuals with untreated AUD (n = 450) from a large, urban, academic hospital in New Haven, CT to: (1) Brief Negotiation Interview (with referral and telephone booster) alone (BNI), (2) BNI plus facilitated initiation of medications for alcohol use disorder (BNI + MAUD), or (3) BNI + MAUD + initiation of computer-based training for cognitive behavioral therapy (CBT4CBT, BNI + MAUD + CBT4CBT). Interventions are delivered by Health Promotion Advocates. The primary outcome is AUD treatment engagement 34 days post-hospital discharge. Secondary outcomes include AUD treatment engagement 90 days post-discharge and changes in self-reported alcohol use and phosphatidylethanol. Exploratory outcomes include health care utilization. We will explore whether the effectiveness of the interventions on AUD treatment engagement and alcohol use outcomes differ across and within racialized and ethnic groups, consistent with disproportionate impacts of AUD. Lastly, we will conduct an implementation-focused process evaluation, including individual-level collection and statistical comparisons between the three conditions of costs to providers and to patients, cost-effectiveness indices (effectiveness/cost ratios), and cost-benefit indices (benefit/cost ratios, net benefit [benefits minus costs). Graphs of individual- and group-level effectiveness x cost, and benefits x costs, will portray relationships between costs and effectiveness and between costs and benefits for the three conditions, in a manner that community representatives also should be able to understand and use. CONCLUSIONS: Project ENHANCE is expected to generate novel findings to inform future hospital-based efforts to promote AUD treatment engagement among diverse patient populations, including those most impacted by AUD. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05338151.