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Abstract: The Community Reinforcement Approach (CRA) is an evidence-based practice for the treatment of substance use disorders (SUDs) and achieving and maintaining abstinence, but few studies have systematically explored the effect of CRA on secondary, yet also important, outcomes, such as social functioning. This study was a secondary data analysis of CTN-0044, “Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders.” The purpose was to examine whether an internet-based version of CRA plus contingency management (Therapeutic Education System, TES) is associated with improved social functioning of individuals seeking substance use disorder treatment in a multi-site clinical effectiveness trial. Social functioning was measured using the 54-item Social Adjustment Scale (SAS) assessing role performance in six domains (work, social and leisure activities, extended family relationships, marital relationship, parenting, and immediate family). Generalized linear mixed models tested the effects of treatment, time, sex, baseline abstinence, baseline social functioning and baseline psychological distress on overall social functioning and across social functioning subscales at the end of the 12-week treatment phase and three and six months post treatment. Results showed no significant association between treatment and total social functioning score or any subscale scores. Being male, however, was significantly associated with better social functioning overall at the end of treatment (p=.024). Additionally, higher levels of psychological distress at baseline predicted significantly worse social functioning at the end of treatment overall (p=.037). Conclusions: While TES was not associated with improvement in social functioning outcomes among participants when compared to TAU, male participants and those with less psychological distress at baseline experienced greater improvements in social functioning at the end of treatment. When integrating TES into community treatment programs, it may be important to have counselors involved to guide clients when choosing modules; completing home practice is also a critical factor in improving outcomes and should be monitored. In addition, improved measures of social functioning may be needed for studies involving patients with substance use disorders as more traditional secondary outcomes, such as social functioning and quality of life, should be more systematically studied in research involving treatment for substance use disorders. Related protocols: CTN-0044

Abstract:

The Therapeutic Education System (TES), an Internet version of the Community Reinforcement Approach plus prize-based motivational incentives, is one of few empirically supported technology-based interventions. To date, however, there has not been a study exploring differences in substance use outcomes or acceptability of TES among racial/ethnic subgroups. This study uses data from a multisite (N=10) effectiveness study of TES to explore whether race/ethnicity subgroups (White [n=267], Black/African American [n=112], and Hispanic/Latino [n=55]) moderate the effect of TES. Generalized linear mixed models were used to test whether abstinence, retention, social functioning, coping, craving, or acceptability differed by racial/ethnic subgroup. Findings demonstrated that race/ethnicity did not moderate the effect of TES versus TAU on abstinence, retention, social functioning, or craving. A three-way interaction (treatment, race/ethnicity, and abstinence status at study entry) showed that TES was associated with greater coping scores among non-abstinent White participants (p=.008) and among abstinent Black participants (p<.001). Acceptability of the TES intervention, although high overall, was significantly different by race/ethnicity subgroup with white participants reporting lower acceptability of TES compared to Black (p=.006) and Hispanic/Latino (p=.008) participants.

Conclusions: Findings from this study lend additional support for the use of technology-based interventions in the treatment of substance use disorders. The acceptability of Internet-delivered interventions among racial/ethnic minority populations suggests promise for increasing access to services and reducing disparities in treatment outcomes. In this large multisite national study, racial/ethnic subgroups received similar benefit from Internet-based CRA/CM and reported high rates of acceptability, with Black participants reporting the highest rates of acceptability. TES should be considered as an additional tool to support usual care in outpatient treatment programs among diverse subgroups of patients.

Related protocols: CTN-0044

Abstract:

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (CTN-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU).

Demographic and clinical characteristics and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N=374) and without internet access (N=133). Primary outcome variables included (1) acceptability of TES (i.e., module completion, acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests, retention measured as time to dropout).

Internet use was common (74%) and was more likely among younger (18-49 year old) participants and those who completed high school (p<.001). Participants randomized to TES (n=255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t=2.49, df=218, p=.01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout. TES was associated with better retention among participants not abstinent at baseline who had internet access.

Conclusions: This study explores the association between internet access and demographic and clinical outcomes among a national multi-site sample of patients entering community-based, outpatient addiction treatment. Overall, the data are encouraging for the potential to use technology-based interventions among diverse outpatient addiction treatment populations. Rates of internet access (in the 90 days prior to enrollment) (74%) were similar to the general population (79%). Further, there was high acceptability of the web-based intervention, especially among participants reporting no recent internet access. Findings also suggest that a lack of recent internet access was not associated with abstinence or retention outcomes. Expanding the capacity of publicly funded community-based addiction treatment programs with acceptable evidence-based health information technologies is imperative. The suitability of providing access and training to web-based interventions within clinics may mitigate barriers to access among vulnerable populations lacking remote internet access.

Related protocols: CTN-0044

Abstract:

Coping strategies are a predictor of abstinence among patients with substance use disorders (SUD). However, little is known regarding the role of coping strategies in the effectiveness of the Community Reinforcement Approach (CRA). Using data from a 12-week randomized control trial assessing the effectiveness of the Therapeutic Education System (TES), an internet-delivered version of the CRA combined with contingency management, this study tested the role of coping strategies as a mediator of treatment effectiveness. 507 participants entering 10 outpatient addiction treatment programs received either treatment-as-usual (TAU), a counselor-delivered treatment (Arm 1), or reduced TAU plus TES wherein 2 hours of TAU per week were replaced by TES (Arm 2). Abstinence from drugs and alcohol was evaluated using urine toxicology and self-report. Coping strategies were measured using the Coping Strategies Scale-Brief Version. Mediation analyses were done following Baron and Kenny’s and path analysis approaches.

The average baseline coping strategies were not significantly different between the two treatment arms. Overall, TES intervention was significantly associated with higher coping strategies scores when accounting for baseline scores. Additionally, higher coping strategies scores at week 12 were associated with an increased likelihood of abstinence during the last 4 weeks of the treatment, while accounting for treatment assignment and baseline abstinence. The effect of TES intervention on abstinence was no longer significant after controlling for coping strategies scores at week 12.

Conclusions: Results of this analysis support the importance of coping skills as a partial mediator of the effectiveness of an internet-version of the CRA combined with contingency management. CRA is an efficacious behavioral approach but implementation is limited, often due to the resources required for proper training and delivery. Thus, this study supports the promising role of internet-assisted therapeutic approaches for substance use disorders and, most importantly, it provides additional evidence of the role of coping strategies as a mechanism of effective SUD treatment.

Related protocols: CTN-0044

Abstract:

The National Drug Abuse Treatment Clinical Trials Network WEB-TX study is one of the largest randomized controlled trials to date examining the effectiveness of an internet-delivered treatment intervention on clinical outcomes among people receiving outpatient substance abuse treatment.

In addition to the primary outcome analysis showing significant improvements in abstinence and treatment retention among people randomized to the internet-delivered treatment arm, the study has produced three methodological publications, four baseline publications, five secondary outcome publications, and an additional seven secondary outcome publications under review or in preparation.

The purpose of this one-hour webinar, presented by Edward Nunes, MD and Aimee Cambell, PhD, was to present a synthesis of WEB-TX study findings focusing on key secondary clinical outcomes and discuss new areas of research for technology-based treatments for substance use disorders.

Additional Resources:

• Download slides (pdf)
• Download handout (pdf)
• List of publications(pdf)

Related protocols: CTN-0044

Abstract:

Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an Internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES) (CTN protocol 0044, “Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”). The study involved an economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry).

Results found that, from the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU participants remained in treatment longer and achieved more days of abstinence than TAU patients. Regarding clinical outcome of abstinent years, TES+TAU qualifies as cost-effective with a level of confidence exceeding 95% for willingness-to-pay values above $20,000. That is, if the stakeholder is willing to pay $20,000 per abstinent-year, it is 95% likely they will find TES+TAU to be a “good value.” In general, findings were more promising for participants who were not abstinent at study entry.

Conclusions: With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. Moreover, depending on providers’ and payers’ thresholds for defining value with regard to abstinence, TES+TAU has a high likelihood of being considered a wise investment. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy.

Related protocols: CTN-0044

Abstract:

This secondary analysis of data from a large, multi-site effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network (CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”), sought to determine whether effects of a web-based behavioral treatment (Therapeutic Education System (TES)) differed by participants’ self-identified primary drug of abuse. The all-comers sample of individuals entering outpatient psychosocial counseling treatment for substance abuse (N=497) cited cannabis (22.9%), stimulants (34.4%), opioids (21.7%), or alcohol (20.9%) as their primary substance of abuse. Participants were randomly assigned to receive treatment-as-usual (TAU) with or without TES substituted for approximately 2 hours of usual counseling. Multivariate analyses of abstinence outcomes examined interactions of treatment effects with primary substance.

Adjusted odds ratios (AORs) demonstrated that primary stimulant users receiving TES were more likely to be abstinent in the final four weeks of treatment compared to stimulant users receiving TAU. Adjusted odds ratios for alcohol and cannabis were also of similar magnitude to stimulants but did not reach significance. Abstinence among primary opioid users was not improved by the TES intervention.

Conclusions: This study supports the TES web-delivered treatment as a viable intervention for the majority of substance users entering outpatient counseling treatment, with demonstrated effectiveness among stimulant users and promising effects in alcohol and cannabis users, but little or no effect in primary opioid users. Web-delivered treatments hold promise for expanding the availability of effective behavioral interventions for the majority of substance use disorders.

Related protocols: CTN-0044

Abstract:

This is the Results Article for CTN-0044-A-2.

Longstanding disparities in substance use disorders and treatment access exist among American Indians/Alaska Natives (AI/AN). Computerized, web-delivered interventions have the potential to increase access to quality treatment and improve patient outcomes. National Drug Abuse Treatment Clinical Trials Network (CTN) protocol CTN-0044 established the efficacy in lowering drop-out rates and increasing abstinence of an interactive, web-based version of the Community Reinforcement Approach (CRA) intervention plus incentives, the Therapeutic Education System (TES). However, TES has not been tested among AI/AN populations. This mixed method acceptability study was conducted at two urban outpatient substance abuse treatment programs affiliated with the Clinical Trials Network; one in the Northern Plains region, the other on the Pacific Northwest. The sample consisted of 40 urban AI/AN, and results found TES acceptable across seven indices (range 7.8-9.4 on 0-10 scales with 10 indicating highest acceptability). Clients gave the highest ratings of acceptability to TES modules that included HIV/STI information, as well as managing triggers that can lead to risky sexual or drug using behavior. Modules receiving lower ratings tended to be those completed earlier; lower rating may reflect features of TES functionality, such as getting comfortable with the interface and answering questions to demonstrate learning to be able to move from one module to the next. Initial, lower acceptable rates, and the relatively low use of the internet of the population at baseline, may indicate that web-based interventions need more comprehensive introduction in this population.

Conclusions: Overall, findings suggest that core TES content is acceptable among a diverse population of AI/AN clients in outpatient substance use treatment. Qualitative interviews suggest adaptation of the TES content specific to AI/AN culture could improve adoption. Additional efforts to adapt TES and conduct a larger effectiveness study are warranted.

Related protocols: CTN-0044-A-2

Abstract:

Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about potential gender differences. This secondary analysis uses data from a National Drug Abuse Treatment Clinical Trials Network multi-site effectiveness trial evaluating a computer-assisted behavioral intervention (CTN-0044), to explore gender differences in acceptability and treatment outcomes. Men (n=314) and women (n=192) were randomly assigned to 12 weeks of treatment-as-usual (TAU) or modified TAU and the Therapeutic Education System (TES), whereby TES substituted for 2 hours of TAU per week. TES consists of 62 web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence, plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were (1) abstinence from drugs and heavy drinking (last 4 weeks of treatment); (2) largest consecutive weeks of abstinence; and (3) retention. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, satisfaction).

Findings showed that gender did not moderate the treatment effect on any of the three outcomes. Acceptability of TES did not differ by gender, however, a gender-by-acceptability interaction for abstinence and consecutive weeks of abstinence demonstrated that acceptability was significantly associated with abstinence, but only among women.

Conclusions: Gender may be an important fact to consider when thinking about using computer-assisted interventions, such as TES. Given the potential for technology to expand access and improve addiction outcomes, future research should strive to understand how to improve acceptability among women and ways to better integrate these interventions into traditional treatment.

Related protocols: CTN-0044

Abstract:

This is the primary outcomes article for CTN-0044.

Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment.

Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate and a greater abstinence rate. This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228).

The superiority of TES over treatment as usual was not sustained at longer-term follow-up, however. This could be due to diminishing effects of contingency management after the contingencies end, or simply because of the chronic, relapsing nature of addiction and the need for ongoing monitoring and treatment.

Conclusions: Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.

Related protocols: CTN-0044