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.

Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT.

OBJECTIVES: Screening, Brief Intervention, and Referral to Treatment (SBIRT) has demonstrated efficacy for addressing unhealthy alcohol use in primary care, yet recent research indicates weaker efficacy for drug use as well as very limited success in referral to specialty care for patients with substance use disorder (SUD). Technology-based interventions for SUD delivered in primary care settings are a potential strategy of efficiently delivering treatment to those who need it. METHODS: We conducted a randomized clinical trial evaluating feasibility, satisfaction, and substance use outcomes for 58 individuals with SUD. Participants being treated in a primary care practice which provides integrated addiction treatment were randomized to standard care or standard care plus access to a web-based SUD intervention (computer-based training in cognitive behavioral therapy, or CBT4CBT). Self-reported substance use and urine toxicology screens were assessed at 8 weeks after randomization. RESULTS: Uptake of CBT4CBT in this setting was high; 77% of those assigned to this condition accessed the program at least once; of those, 77% completed all 7 modules. Satisfaction with the program was very high. Participants reported >90% days abstinent for all classes of drugs; with no significant differences between conditions. CONCLUSIONS: This study demonstrates feasibility of implementing technology-based treatments in primary care settings to address weak follow-through with the referral component of SBIRT. The overall positive outcomes in this specialized, integrated treatment setting may have undercut the ability to demonstrate differential effects on substance use; results suggest evaluation in less specialized primary care settings is warranted. TRIAL REGISTRATION: clinicaltrials.gov NCT03013478.

Treatment process, alliance and outcome in brief versus extended treatments for marijuana dependence.

AIMS: The Marijuana Treatment Project, a large multi-site randomized clinical trial, compared a delayed treatment control condition with a brief (two-session) and extended (nine-session) multi-component treatment among 450 marijuana-dependent participants. In this report we present treatment process data, including the fidelity of treatment delivery in the three community-based treatment settings as well as the relationships between treatment process and outcome. DESIGN: Independent evaluations of clinician adherence and competence ratings were made based on 633 videotaped sessions from 163 participants. Relationships between clinician adherence and competence, ratings of the working alliance and marijuana treatment outcomes were evaluated. FINDINGS: Protocol treatments were implemented with strong fidelity to manual specifications and with few significant differences in adherence and competence ratings across sites. In the brief two-session treatment condition, only the working alliance was associated significantly with frequency of marijuana use, but in the extended treatment therapist ratings of working alliance predicted outcomes, as did the interaction of alliance and curvilinear adherence. CONCLUSIONS: Behavioral treatments for marijuana use were delivered in community settings with good fidelity. Participant and therapist working alliance scores were associated significantly with improved marijuana use outcomes in a brief behavioral treatment for adults with marijuana dependence. In extended treatment the therapist ratings of working alliance were associated with more positive outcome. However, in that treatment there was also a significant interaction between alliance and curvilinear adherence.