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.

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. In this commentary, we describe general guidance on culturally responsive modifications to facilitate the successful recruitment and retention of Spanish-speaking Latinx participants in Randomized Clinical Trials (RCTs) for substance use. We identify five culturally responsive strategies to help enroll participants in RCTs: 1. Create an ethnically diverse research team, 2. Assess available community partners, 3. Familiarize oneself with the target community, 4. Establish confianza (trust) with participants, and 5. Remain visible to participants and staff from recruitment sites. Representation of Latinx individuals in clinical trials is essential to ensure treatments are responsive to their needs and equitydriven. Some of these strategies can further research in helping to promote the participation of Latinx individuals experiencing substance use concerns, including outreach to those not seeking treatment.

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.

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. The ROC task was administered pre- and postintervention to assess changes in cue-induced craving and mindfulness- and reappraisal-based regulation of craving. RESULTS: MBT and CBT-versus control-showed significantly greater reductions in smoking during the intervention phase (baseline to Week 4), corresponding to large (d = -1.08, 95% CI [-1.64, -0.52]) and medium-to-large effect sizes (d = -0.69, 95% CI [-1.22, -0.15]), respectively. During follow-up (Week 4-16), CBT showed significant increases in smoking, whereas MBT and control did not. For the entire study (baseline to Week 16), MBT showed significantly greater reductions in smoking compared to control (d = -1.6, 95% CI [-2.56, -0.66]) but CBT was not significantly different than control (d = -0.82, 95% CI [-1.77, 0.13]). There were no effects on smoking when directly comparing MBT and CBT. Quit rates were low across the sample, with no difference among conditions. MBT and CBT-versus control-significantly reduced cue-induced craving. CBT (but not MBT)-versus control-significantly improved reappraisal-based regulation of craving. Both MBT and CBT-versus control-significantly improved mindfulness-based regulation of craving. CONCLUSIONS: MBT- and CBT-ROC-T may reduce cue-induced craving and smoking, and MBT may be more durable than CBT. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

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.

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 telenovela 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. Participants endorsed high levels of satisfaction with the program content and found the material to be easy to understand and relevant to their life experiences.

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. Past-year religiosity was positively correlated with one measure of abstinence for those randomized to CBT4CBT-Spanish, but this did not persist during a six-month follow-up period. Findings suggest that religiosity may be associated with short-term abstinence outcomes among Latinx adults receiving a culturally adapted cognitive behavioral therapy treatment. However, additional research is needed with larger and more heterogenous Latinx populations.

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; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping. RESULTS: There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping. CONCLUSIONS: Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.

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). The Structured Clinical Interview for DSM-IV (SCID-IV) was administered at baseline and at the end of the 8-week treatment period to measure change in diagnostic status and total criteria count. Frequency of substance use during treatment and throughout a 6-month follow-up period was measured by self-report using a calendar-based Timeline FollowBack method, with abstinence verified through instant urine toxicology, and problem severity was measured with the Addiction Severity Index (ASI). Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X2 = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X2 = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only. Total criteria count and diagnostic status at end-of-treatment was significantly correlated with substance use outcomes during the follow-up period, such that fewer criteria endorsed were associated with greater rates of abstinence and lower problem severity. These findings paralleled the primary outcomes from the main trial, and replicated prior findings in English-speakers regarding the utility of DSM criteria count as a potential clinically meaningful outcome.

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. The relationship of uncomfortable physical and dysphoric symptoms to retention on naltrexone is a controversial and under-studied issue. METHODS: Using data from a randomized controlled trial of voucher-based contingency management and support from a significant other to enhance retention on oral naltrexone, we compared self-reported somatic and dysphoric symptoms, measured weekly, for individuals who were retained on naltrexone through the 12-week trial (n = 50) versus those who dropped out (n = 70). RESULTS: There were no differences between participants who completed treatment and those who dropped out on multiple baseline characteristics, including somatic or affective symptoms prior to treatment. However, whether analyzed cross-sectionally or over time, participants who dropped out consistently reported higher rates of somatic symptoms, particularly difficulty sleeping, as well as affective symptoms, including multiple indicators of depression, anxiety, and anhedonia. CONCLUSIONS: Although the smaller group of participants who were retained on oral naltrexone for 12 weeks reported decreasing physical and affective discomfort over time, there was substantial evidence that those who dropped out experienced continued and significant levels of distress. Individuals who report physical or affective distress while taking naltrexone may be at higher risk of dropout.

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.

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. RESULTS: Rates of treatment exposure differed by group, with the best retention in the CBT4CBT group and the poorest in the individual CBT group. Participants who received CBT or CBT4CBT reduced their frequency of substance use significantly more than those who received treatment as usual. Six-month follow-up outcomes indicated continuing benefit of CBT4CBT (plus monitoring) over treatment as usual, but not for clinician-delivered CBT over treatment as usual. Analysis of secondary outcomes indicated that participants in the CBT4CBT group demonstrated the best learning of cognitive and behavioral concepts, as well as the highest satisfaction with treatment. CONCLUSIONS: This first trial of computerized CBT as a virtual stand-alone intervention delivered in a clinical setting to a diverse sample of patients with current substance use disorders indicated that it was safe, effective, and durable relative to standard treatment approaches and was well-liked by participants. Clinician-delivered individual CBT, while efficacious within the treatment period, was unexpectedly associated with a higher dropout rate and lower effects at follow-up.

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.

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. METHOD: This study combined data from 4 randomized clinical trials of CBT for cocaine dependence to examine relationships among homework adherence, participant variables, and cocaine use outcomes during treatment and at follow-up. The data set included only participants who attended at least 2 CBT sessions to allow for assignment and return of homework (N = 158). RESULTS: Participants returned slightly less than half (41.1%) of assigned homework. Longitudinal random effects regression suggested a greater reduction in cocaine use during treatment and through 12-month follow-up for participants who completed half or more of assigned homework (3-way interaction), F(2, 910.69) = 4.28, p = .01. In multiple linear regression, the percentage of homework adherence was associated with greater number of cocaine-negative urine toxicology screens during treatment, even when accounting for baseline cocaine use frequency and treatment attendance; at 3 months follow-up, multiple logistic regression indicated homework adherence was associated with cocaine-negative urine toxicology screen, controlling for baseline cocaine use and treatment attendance. CONCLUSIONS: These results extend findings from prior studies regarding the importance of homework adherence by demonstrating associations among homework and cocaine use outcomes during treatment and up to 12 months after, independent of treatment attendance and baseline cocaine use severity. (PsycINFO Database Record

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. The MET-E sample included 461 participants and the MET-S sample included 405 participants. Outcome expectations were measured by a single item regarding expectations about abstinence prior to initiating treatment. RESULTS: Outcome expectations were strongly associated with most substance use outcomes in the MET-S trial (but not in MET-E), even after controlling for severity of substance use at baseline. In MET-S, those who indicated that they were "unsure" that they would achieve abstinence during treatment submitted a greater percentage of drug-positive urine toxicology screens during the treatment period than those who were 'sure' they would achieve abstinence (F = 18.83, p < .001). DISCUSSION AND CONCLUSIONS: Patients' outcome expectations regarding the likelihood of abstinence may be an important predictor of drug use treatment outcomes among Spanish-speakers, but not necessarily for English-speakers. SCIENTIFIC SIGNIFICANCE: Individual differences and cultural factors may play a role in the association between outcome expectations and treatment outcomes.

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. RESULTS: There was a significant genotype by time effect on frequency of cocaine use from baseline to the end of the 6 month follow-up, suggesting greater reductions over time for Val carriers relative to individuals with the Met/Met genotype. There was a significant treatment condition by genotype interactions for rates of participants attaining 21 or more days of continuous abstinence as well as self-reported percent days of abstinence, suggesting less cocaine use among Val carriers when assigned to CBT compared to standard treatment. Exploration of possible mechanisms using measures of attentional biased also pointed to greater change over time in these measures among the Val carriers assigned to CBT. CONCLUSION: These are the first data from a randomized controlled trial indicating significant interactions of COMT polymorphism and behavioral therapy condition on treatment outcome, where Val carriers appeared to respond particularly well to computerized CBT. These preliminary data point to a potential biomarker of response to CBT linked to its putative mechanism of action, enhanced cognitive control.

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) = 5.78, p < .05]. Scores on the WAI-Tech were not associated with cocaine use outcomes, whereas total scores on the WAI for those assigned to TAU were associated with the percentage of days abstinent from cocaine (r = .43, p < .05). There was little evidence that adding a technology-based intervention adversely affected the working alliance with a therapist in this sample. These preliminary findings suggest some concepts of working alliance may apply to computer-based CBT, yet the function of the alliance may be different in technology-based interventions than in face-to-face psychotherapies.

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.