Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned.

Objective: This study aimed to describe initial experiences and lessons learned conducting a trial focused on recruiting racially and ethnically diverse hospitalized patients with untreated alcohol use disorder (AUD).

Methods: The parent trial is comparing the effectiveness of strategies including Brief Negotiation Interview (BNI), facilitated initiation of medications for AUD, and computer-based training for cognitive behavioral therapy (CBT4CBT) on AUD treatment engagement post-hospitalization. Guided by the Framework for Reporting Adaptations and Modifications-Enhanced, we catalogued protocol changes and evaluated outcomes using study and electronic medical record data during the first 18 months of recruitment.

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.

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").

Enrollment of Spanish-speaking Latinx adults in clinical trials: Five lessons learned from a randomized study in substance use treatment.

Latinx individuals are the largest ethnic minoritized group in the United States (US) at 19% of the population. However, they remain underrepresented in clinical research, accounting for less than 8% of clinical trial participants. Consideration of cultural values could help overcome barriers to inclusion in clinical trials and result in better recruitment and retention of Latinx individuals.

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.

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers.

Objective: Craving predicts smoking, yet existing interventions may not adequately target regulation of craving. We evaluated two versions of regulation of craving-training (ROC-T), a computerized intervention with intensive practice of strategies when exposed to smoking-related images.

Method: Ninety-two nicotine-dependent daily smokers were randomized to mindfulness-based therapy (MBT) ROC-T focusing on mindful acceptance, and cognitive behavioral therapy (CBT) ROC-T focusing on reappraisal or no intervention control.

Computer-based training for cognitive behavioral therapy for Spanish-speaking substance users: adaptation and satisfaction.

There are few available culturally and linguistically adapted behavioral health interventions for substance use among Spanish-speaking adults. The authors describe the cultural adaptation of an innovative computer-based training for cognitive behavioral therapy program (CBT4CBT). Based in cognitive-behavioral skills training, CBT4CBT utilizes a to teach monolingual Spanish-speaking adults who have migrated to the United States to recognize triggers; avoid these situations; and cope more effectively with the consequences of substance use.

Religiosity and Spirituality in Latinx Individuals with Substance Use Disorders: Association with Treatment Outcomes in a Randomized Clinical Trial.

Although many studies have examined religiosity as a protective factor for substance use, few have considered its relationship to treatment outcomes among Latinx adults. Using data from 89 individuals participating in a randomized clinical trial evaluating a culturally adapted Spanish-language version of web-based cognitive behavioral therapy (CBT4CBT-Spanish) for substance use, we evaluated the relationship between religiosity, as measured by the Religious Background and Behavior questionnaire, and treatment outcomes. Overall, there were few significant correlations between religiosity scores and treatment outcomes.

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.

Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.

Background: No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).

Methods: We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.

Changes in DSM criteria following a culturally-adapted computerized CBT for Spanish-speaking individuals with substance use disorders.

This study sought to replicate and extend findings regarding change in the number of endorsed Diagnostic and Statistical Manual (DSM) criteria for substance use disorders as a meaningful outcome for clinical trials with Spanish-speakers. A secondary analysis was conducted of data from 83 treatment-seeking individuals with current DSM-IV substance dependence participating in a randomized controlled trial evaluating a culturally-adapted version of a computer-based cognitive behavioral therapy program (CBT4CBT) for Spanish-speakers. Participants were randomized to either weekly standard outpatient counseling (treatment as usual - TAU), or TAU plus access to CBT4CBT (TAU+CBT4CBT).

Accounting for the uncounted: Physical and affective distress in individuals dropping out of oral naltrexone treatment for opioid use disorder.

Background: The theoretical benefits of naltrexone as a treatment for opioid use disorder (e.g., safety, non-addictive, low risk of diversion) stand in sharp contrast to its disappointing record on retention in most samples.

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.

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.

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes.

Objective: Previous trials have demonstrated the efficacy and durability of computer-based cognitive-behavioral therapy (CBT4CBT) as an add-on to standard outpatient care in a range of treatment-seeking populations. In this study, the authors evaluated the efficacy and safety of CBT4CBT as a virtual stand-alone treatment, delivered with minimal clinical monitoring, and clinician-delivered cognitive-behavioral therapy (CBT) compared with treatment as usual in a heterogeneous sample of treatment-seeking outpatients with substance use disorders.

Method: This was a randomized clinical trial in which 137 individuals who met DSM-IV-TR criteria for current substance abuse or dependence were randomly assigned to receive treatment as usual, weekly individual CBT, or CBT4CBT with brief weekly monitoring.

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).

Just showing up is not enough: Homework adherence and outcome in cognitive-behavioral therapy for cocaine dependence.

Objective: Homework in cognitive-behavioral therapy (CBT) provides opportunities to practice skills. In prior studies, homework adherence was associated with improved outcome across a variety of disorders. Few studies have examined whether the relationship between homework adherence and outcome is maintained after treatment end or is independent of treatment attendance.

Outcome expectations and associated treatment outcomes in motivational enhancement therapy delivered in English and Spanish.

Background And Objectives: The relationship between patients' baseline expectations regarding treatment outcome and actual outcomes has not been widely studied within the field of substance use disorders. We hypothesized that outcome expectations would be unrelated to outcomes in a study investigating motivational enhancement therapy delivered in English (MET-E) consistent with our earlier work, and conducted exploratory analyses in a separate study that investigated the same treatment delivered in Spanish (MET-S).

Methods: These secondary analyses compared patient outcome expectations and substance use treatment outcomes in two large, multisite randomized controlled clinical trials that evaluated three sessions of MET-E or MET-S.

Catehol-o-methyltransferase gene Val158met polymorphism as a potential predictor of response to computer-assisted delivery of cognitive-behavioral therapy among cocaine-dependent individuals: Preliminary findings from a randomized controlled trial.

Background: Findings from uncontrolled studies suggest that the COMT Val108/158Met polymorphism may affect response to cognitive behavioral therapy (CBT) in some populations. Using data from a randomized controlled trial evaluating computerized CBT (CBT4CBT), we evaluated treatment response by COMT genotype, with the a priori hypothesis that Val carriers would have improved response to computerized delivery of CBT.

Methods: 101 cocaine-dependent individuals, of whom 81 contributed analyzable genetic samples, were randomized to standard methadone maintenance treatment plus CBT4CBT or standard treatment alone in an 8 week trial.

Only connect: The working alliance in computer-based cognitive behavioral therapy.

The limited role of therapists in some technology-based interventions raises questions as to whether clients may develop a 'working alliance' with the program, and the impact on relationships with a therapist and/or treatment outcomes. In this study, the Working Alliance Inventory (WAI), and an adapted version for technology-based interventions (WAI-Tech), were administered within a subsample (n = 66) of cocaine-dependent individuals participating in a randomized trial evaluating the efficacy of Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) as an adjunct to treatment as usual (TAU). Results suggest the WAI-Tech has relatively similar psychometric characteristics as the standard WAI; however the 'bond' subscale scores were lower on the WAI-Tech [F(1,52) = 5.

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.

Mentorship for Alcohol Problems (MAP): a peer to peer modular intervention for outpatients.

Aims: This is a Stage I open pilot to develop a new intervention, Mentorship for Alcohol Problems (MAP), for individuals with alcohol-use disorders in community treatment programs.

Methods: Ten mentors participated for 6 months until 30 mentees received MAP for 12 weeks. Behavioral and biological measures were conducted in addition to fidelity measures.