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Abstract: Traditional treatments for substance use disorders (SUDs) rely heavily on face-to-face interactions, which pose substantial limitations for patients. A clinical trial of a digital therapeutic (DT) delivering behavioral therapy demonstrated safety and efficacy in a population including patients with opioid use disorder (OUD) not treatment with buprenorphine, which is not a guideline-recommended approach. This study re-analyzed the data excluding patients with OUD to more closely approximate real-world patient populations. The study was a secondary analysis of data from CTN-0044 (“Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders;” n=399 after patients with OUD were excluded). Patients received 12 weeks of outpatient treatment-as-usual (TAU; n=193) or TAU with reduced counseling plus a digital therapeutic (DT; n=206) providing computerized cognitive behavioral therapy and contingency management (the reSET, a commercial version of the Therapeutic Education System (TES)). Primary outcomes were abstinence in weeks 9-12 and retention in treatment. The 399 patients in the analysis (206 in the DT group and 193 in the TAU group) reported substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (e.g. methamphetamine). Demographic and baseline characteristics including age, sex, race, education, and reported primary substance use disorder were balanced between treatment groups. Abstinence was significantly higher in the DT group compared to the TAU group (40.3 vs. 17.6%), as was retention in therapy (76.2 vs. 63.2%). Conclusions: These results demonstrate that use of a digital therapeutic safely increased abstinence (reduced substance use) and retention in treatment among patients with substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (including methamphetamines). Related protocols: CTN-0044

Abstract:

Patient engagement may play a key role in the success or failure of treatments for substance use disorder (SUD). This exploratory analysis of data from a large, multisite effectiveness trial (CTN-0044) sought to determine how patient engagement with a digital therapeutic for SUD delivered at clinics was associated with abstinence outcomes.

The study evaluated engagement for 206 participants enrolled in a treatment program for SUDs related to cocaine, alcohol, cannabis, or other stimulants who were randomized to receive treatment as usual (TAU) or reduced TAU plus the digital Therapeutic Education System (TES) for 12 weeks. Participants were eligible for contingency management incentives for module completion (modules cover Community Reinforcement Approach topic areas) and negative urine drug screens. Analyses examined the association of module completion with end-of-treatment abstinence.

Participants completed a mean of 38.8 (range 0–72) TES modules over 12 weeks of treatment. Study completers (n = 157) completed a mean of 45.5 (range 9–72) TES modules, whereas study noncompleters (n = 49) completed a mean of 17.4 (range 0–45) TES modules. The study observed a strong positive correlation between TES engagement (i.e., total number of modules completed) and the probability of abstinence during weeks 9–12 of treatment among 157 study completers. Each module completed increased the odds of abstinence during weeks 9–12 by approximately 11% for study completers and 9% for the full sample. The study observed a similar, but weaker, association between engagement and abstinence among 49 patients who did not complete the study.

Conclusions: Greater engagement with a digital therapeutic for patients with SUD (i.e., number of modules completed over time) was strongly associated with the probability of abstinence in the last four weeks of treatment among those who completed the recommended 12-week treatment.

Related protocols: CTN-0044

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:

Substance use disorders are associated with lower cognitive functioning, and this impairment is associated with poorer outcomes. The Therapeutic Education System (TES) is an internet-based psychosocial intervention for substance use disorders that may provide enhanced treatment for individuals with cognitive deficits. This secondary analysis investigates the association between cognitive functioning and treatment outcomes in a large (N=507) randomized controlled effectiveness trial of TES compared to treatment-as-usual conducted within outpatient programs in the NIDA Clinical Trials Network (CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”).

Participants in the study completed a computer-based cognitive assessment (MicroCog (TM) short version) at baseline. Scores on subtests of attention, reasoning, and spatial perception were tested as moderators of the treatment effect on abstinence and retention at the end of the 12-week treatment phase using mixed effects logistic regression.

Cognitive functioning was not found to be a moderator of treatment on abstinence or retention. Post-hoc analysis of the main effect of cognitive functioning on retention and abstinence found impaired reasoning and cognitive flexibility were associated with lower retention. There were no other main effects of cognitive functioning on retention or abstinence.

Conclusions: The benefit of internet-delivered treatment over standard care was unchanged across a range of cognitive functioning. Consistent with previous research, mild to moderate impairment in reasoning and cognitive flexibility were associated with lower retention across both treatment arms. TES appears to be equally effective across a spectrum of cognitive functioning among diverse patients. Further study is needed to determine mechanisms by which cognitive functioning influences retention in treatment and to optimize technology-based interventions for those with cognitive impairment.

Related protocols: CTN-0044

Abstract:

There is growing concern regarding the generalizability of findings from randomized controlled trials (RCTs) of interventions for substance use disorders (SUDs). This study used a selection model approach to assess and improve the generalizability of an evaluation for a web-based SUD intervention by making the trial sample resemble the target population.

The sample of the web-based SUD intervention (Therapeutic Education System vs. treatment-as-usual; n=507) was compared with the target population of SUD treatment-seeking individuals from the Treatment Episodes Data Set-Admissions (TEDS-A). Using weights based on the probabilities of RCT participation, weighted treatment effects on retention and abstinence were computed.

Substantial differences between the RCT sample and the target population were demonstrated in significant difference in the mean propensity scores (1.62 standard deviations at p<.001). The population effect on abstinence (12 weeks and 6 months) was statistically insignificant after weighting the data with the generalizability weight.

Conclusions: Findings from this study provide insights into the differences between RCT participants of a web-based SUD intervention and the target population from recent years. The results of this study also indicate how poor sample representativeness of the RCT compared with the target population impacted the observed findings of the web-based SUD intervention. Given the great potential for scalability of web-based SUD interventions, the representativeness of the sample with regard to the target population of potential users for the intervention should be carefully considered. Additionally, with a careful consideration of the treatment effect modifiers which are over- or under-representing in RCTs, application of generalizability weights could be a potentially useful tool for assessing and improving the generalizability of the findings from RCTs when the RCT sample does not well-represent the target population.

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, feasibility, and effectiveness of web-based interventions among criminal justice-involved populations are understudied. This study is a secondary analysis of baseline characteristics associated with criminal justice system (CJS) status as treatment outcome moderators among participants enrolling in a large randomized trial of a web-based psychosocial intervention (Therapeutic Education System [TES]) as part of outpatient addiction treatment.

Using data from CTN-0044 (Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders), the authors compared demographic and clinical characteristics, TES participation rates, and the trial’s two co-primary outcomes (end of treatment abstinence and treatment retention) by self-reported CJS status at baseline: 1) CJS-mandated to community treatment (CJS-mandated), 2) CJS-recommended to treatment (CJS-recommended), 3) no CJS treatment mandate (CJS-none).

Results found that CJS-mandated (n=107) and CJS-recommended (n=69) participants differed from CJS-none (n=331) at baseline: CJS-mandated were significantly more likely to be male, screen negative for depression, and score lower for psychological distress and higher on physical health status; CJS-recommended were younger, more likely single, less likely to report no regular Internet use, and to report cannabis as the primary drug problem. Both CJS-involved (CJS-recommended and -mandate) groups were more likely to have been recently incarcerated. Among participants randomized to the TES arm, module completion was similar across the CJS subgroups. A three-way interaction of treatment, baseline abstinence, and CJS status showed no associations with the study’s primary abstinence outcome.

Conclusions: Overall, CJS-involved participants in this study tended to be young, male, and in treatment for a primary cannabis problem. The feasibility and effectiveness of the web-based psychosocial intervention, TES, did not vary by CJS-mandated or CJS-recommended participants compared to CJS-none; CJS-involved participants appeared to experience the usual expected benefits in this large multisite randomized trial. These results should encourage treatment providers, policy makers, and CJS authorities to further consider online psychosocial interventions as viable and appropriate therapeutic approaches in CJS addiction treatment populations.

Related protocols: CTN-0044

Abstract:

This study aimed to examine prize-earning costs of contingency management (CM) incentives in relation to participants’ pre-study enrollment drug use status (baseline (BL) positive vs. BL negative) and relate these to previously reported patterns of intervention effectiveness. Participants were 255 substance users entering outpatient treatment who received the therapeutic education system (TES) in addiction to usual care counseling (as part of NIDA Clinical Trials Network protocol CTN-0044). TES included a CM component such that participants could earn up to $600 in prizes on average over 12-weeks for providing drug negative urines and completing web-based cognitive behavior therapy modules. This secondary analysis examined distribution of prize draws and value of prizes earned for subgroups that were abstinent (BL negative; N=136) or not (BL positive; N=119) at study entry based on urine toxicology and breath alcohol screen.

Results found that distribution of draws earned (median=119 vs. 17; p < .0001) and prizes redeemed (median=54 vs. 9; p < .001) for drug abstinence differed significantly for BL negative compared to BL positive participants. BL negative earned on average twice as much in prizes as BL positive participants ($245 vs. $125). Median value of prizes earned was 5.4 times greater for BL negative compared to BL positive participants ($237 vs. $44; p<.001).

Conclusions: Two-thirds of expenditures in an abstinence incentive program were paid to BL negative participants. These individuals had high rates of drug abstinence during treatment and did not show improve abstinence outcomes with TES versus usual care. Effectiveness of the abstinence-focused CM intervention in TES may be enhanced by tailoring delivery based on patients’ drug use status at treatment entry.

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:

The growing use of newer communication and internet technologies, even among low income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the internet to track participants in a multi-site randomized trial of substance use disorder treatment. Pre-interview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 sites participating in the National Drug Abuse Treatment Clinical Trials Network study CTN-0044, about an online intervention for substance use disorders (Therapeutic Education System). Data were then used to construct a semi-structured interview guide which, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant tracking purposes.

Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants’ cell phones also proved problematic at times. Even homeless participants were found to have access to the internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the Institutional Review Board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary websites were also helpful tool.

Conclusions: Research staff perceive that cell phones, internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research and should be used in addition to established study procedures. Studies should incorporate cell phone, texting, and social network website information on locator forms; obtain IRB approval for contacting participants using social networking websites; and include web searches, texting, and the use of social media in staff training as standard operating procedures.

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