Momentary Influences on Self-Regulation in Two Populations With Health Risk Behaviors: Adults Who Smoke and Adults Who Are Overweight and Have Binge-Eating Disorder.

Introduction: Self-regulation has been implicated in health risk behaviors and is a target of many health behavior interventions. Despite most prior research focusing on self-regulation as an individual-level trait, we hypothesize that self-regulation is a time-varying mechanism of health and risk behavior that may be influenced by momentary contexts to a substantial degree. Because most health behaviors (e.g., eating, drinking, smoking) occur in the context of everyday activities, digital technologies may help us better understand and influence these behaviors in real time. Using a momentary self-regulation measure, the current study (which was part of a larger multi-year research project on the science of behavior change) used ecological momentary assessment (EMA) to assess if self-regulation can be engaged and manipulated on a momentary basis in naturalistic, non-laboratory settings. Methods: This one-arm, open-label exploratory study prospectively collected momentary data for 14 days from 104 participants who smoked regularly and 81 participants who were overweight and had binge-eating disorder. Four times per day, participants were queried about momentary self-regulation, emotional state, and social and environmental context; recent smoking and exposure to smoking cues (smoking sample only); and recent eating, binge eating, and exposure to binge-eating cues (binge-eating sample only). This study used a novel, momentary self-regulation measure comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Participants were also instructed to engage with Laddr, a mobile application that provides evidence-based health behavior change tools via an integrated platform. The association between momentary context and momentary self-regulation was explored via mixed-effects models. Exploratory assessments of whether recent Laddr use (defined as use within 12 h of momentary responses) modified the association between momentary context and momentary self-regulation were performed via mixed-effects models. Results: Participants (mean age 35.2; 78% female) in the smoking and binge-eating samples contributed a total of 3,233 and 3,481 momentary questionnaires, respectively. Momentary self-regulation subscales were associated with several momentary contexts, in the combined as well as smoking and binge-eating samples. For example, in the combined sample momentary perseverance was associated with location, positively associated with positive affect, and negatively associated with negative affect, stress, and tiredness. In the smoking sample, momentary perseverance was positively associated with momentary difficulty in accessing cigarettes, caffeine intake, and momentary restraint in smoking, and negatively associated with temptation and urge to smoke. In the binge-eating sample, momentary perseverance was positively associated with difficulty in accessing food and restraint in eating, and negatively associated with urge to binge eat. While recent Laddr use was not associated directly with momentary self-regulation subscales, it did modify several of the contextual associations, including challenging contexts. Conclusions: Overall, this study provides preliminary evidence that momentary self-regulation may vary in response to differing momentary contexts in samples from two exemplar populations with risk behaviors. In addition, the Laddr application may modify some of these relationships. These findings demonstrate the possibility of measuring momentary self-regulation in a trans-diagnostic way and assessing the effects of momentary, mobile interventions in context. Health behavior change interventions may consider measuring and targeting momentary self-regulation in addition to trait-level self-regulation to better understand and improve health risk behaviors. This work will be used to inform a later stage of research focused on assessing the transdiagnostic mediating effect of momentary self-regulation on medical regimen adherence and health outcomes. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT03352713.

Evaluating the Effectiveness of a Web-Based Program (POP4Teens) to Prevent Prescription Opioid Misuse Among Adolescents: Randomized Controlled Trial.

BACKGROUND: Prescription opioid (PO) use is common among adolescents in the United States. Despite recent declines from unprecedented peaks in adolescent PO use (eg, in 2012-2013), there is seemingly paradoxical evidence that PO-related consequences (eg, opioid use disorder and overdoses) are increasing. These trends and their possible consequences emphasize the importance of prevention efforts targeting PO misuse. To our knowledge, we have developed the first interactive web-based program (POP4Teens [P4T]) focused specifically on the prevention of PO misuse among adolescents. OBJECTIVE: This study aimed to evaluate the effectiveness of P4T, a web-based program designed to prevent adolescent PO misuse, in comparison with JustThinkTwice (JTT), an active control website, on PO-related attitudes, knowledge, risk perception, and intentions to use. METHODS: We conducted a web-based randomized controlled trial in 2018. A total of 406 adolescents (aged 12-17 years) were randomly assigned to either P4T or JTT. The outcome variables were attitudes, knowledge, and risk perceptions associated with PO misuse, intentions to use POs, and program feedback. Data were collected at baseline and at 1, 3, and 6 months. RESULTS: Both programs resulted in significant and sustained improvements in intention to use POs, increased perceived risk, impacted expectancies consistent with prevention, and improved PO refusal skills. P4T produced significantly greater increases in PO-related knowledge than JTT did, and it was reportedly easier to use and more liked. Baseline scores for youth reporting past-year medical use of POs, friends who engage in nonmedical use of POs, and/or poor mental health underscored their at-risk status compared with youth from the other groups. CONCLUSIONS: P4T positively impacted all study variables that are known to prevent PO misuse among teens. Moreover, its web-based nature simplifies the dissemination and implementation of this novel tool designed to help meet the challenges of the evolving national opioid crisis. TRIAL REGISTRATION: ClinicalTrials.gov NCT02737696; https://clinicaltrials.gov/ct2/show/NCT02737696.

Web-Based Prescription Opioid Abuse Prevention for Adolescents: Program Development and Formative Evaluation.

BACKGROUND: The unprecedented number of youths engaged in nonmedical use of prescription opioids (POs), as well as the myriad negative consequences of such misuse, emphasizes the importance of prevention efforts targeting this public health crisis. Although there are several science-based, interactive drug abuse prevention programs focused on preventing the use of nonprescription drugs in youths, to our knowledge, there are no science-based interactive programs that focus on the prevention of PO abuse among adolescents. OBJECTIVE: The aim of this study was to develop and conduct a formative evaluation of a science-based interactive Web-based program focused on the prevention of PO abuse among adolescents aged 12 to 17 years (Pop4Teens). This study was conducted to prepare for a randomized controlled trial designed to evaluate the effectiveness of Pop4Teens compared with an active control website, JustThinkTwice.com (Drug Enforcement Administration), in impacting knowledge and attitudes about POs and perceptions of risk associated with the abuse of POs, as well as intentions to use and actual use of POs. METHODS: We conducted 6 focus groups with 30 youths (a mean of 5 per group: the eligibility being aged 12-19 years) along a continuum of exposure to POs (in treatment for opioid use disorder, in general treatment for other substance use disorder, prescribed an opioid, and opioid-naïve) and writing sessions with 30 youths in treatment for opioid use disorder (12-19 years) to inform the development of the Web-based prevention tool. Feasibility and acceptability of a prototype of the Web-based intervention were then assessed through individual feedback sessions with 57 youths (drawn from the same populations as the focus groups). RESULTS: We successfully completed the development of a Web-based PO abuse prevention program (Pop4Teens). Analyses of focus group transcripts informed the development of the program (eg, quiz content/format, script writing, and story editing). Selected writing session narratives anchored the planned scientific content by lending credibility and informing the development of compelling storylines intended to motivate the youth to engage with the program. Feedback session data indicated that the Web-based tool could be potentially useful and acceptable. In addition, feedback session participants demonstrated significant increases in their knowledge of key topics related to the prevention of PO abuse after the exposure to sections of the Web-based program. CONCLUSIONS: The opioid crisis is predicted to get worse before it gets better. An effective response will likely require a multipronged strategy inclusive of effective evidence-based prevention programs acceptable to, and accessible by, a majority of youths.

Technology-Based Contingency Management in the Treatment of Substance-Use Disorders.

Contingency management is one of the most efficacious interventions to promote drug abstinence. Contingency management has traditionally been delivered in person so that clinicians could confirm drug abstinence and provide access to additional therapeutic services. Now, new technologies not only permit remote confirmation of abstinence, but also remote delivery of incentives. We discuss several technology-based tools to assess substance use, and new ways to deliver contingency management to promote tobacco, alcohol, and cannabis abstinence. These new tools have the potential to dramatically increase access while maintaining high levels of treatment fidelity. Technology-based methods also allow arranging group contingencies that harness online communities, and they permit targeting multiple health-risk behaviors with a combination of sensor-based technologies. Overall, there are unprecedented opportunities to link technology with contingency management to promote drug abstinence.

Web-Delivered CBT Reduces Heavy Drinking in OEF-OIF Veterans in Primary Care With Symptomatic Substance Use and PTSD.

Veterans from conflicts such as the wars in Iraq and Afghanistan commonly return with behavioral health problems, including posttraumatic stress disorder (PTSD) and hazardous or harmful substance use. Unfortunately, many veterans experience significant barriers to receiving evidence-based treatment, including poor treatment motivation, concerns about stigma, and lack of access to appropriate care. To address this need, the current study developed and evaluated a web-based self-management intervention based on cognitive behavioral therapy (CBT), targeting PTSD symptoms and hazardous substance use in a group of symptomatic combat veterans enrolled in VA primary care. Veterans with PTSD/subthreshold PTSD and hazardous substance use were randomized to primary care treatment as usual (TAU; n = 81) or to TAU plus a web-based CBT intervention called Thinking Forward (n = 81). Thinking Forward consisted of 24 sections (approximately 20 minutes each), accessible over 12 weeks. Participants completed baseline and 4-, 8-, 12-, 16-, and 24-week follow-up assessments. Three primary outcomes of PTSD, alcohol and other drug use, and quality of life were examined. Significant treatment effects were found for heavy drinking, but not for PTSD or quality of life. The effect of the intervention on heavy drinking was mediated by intervening increases in coping, social support, self-efficacy, and hope for the future. These results demonstrate the promise of a web-based, self-management intervention for difficult-to-engage OEF/OIF veterans with behavioral health and substance use concerns.

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial.

BACKGROUND AND AIMS: Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. DESIGN: Randomized controlled trial with 3- and 6-month follow-ups. SETTING: United States. PARTICIPANTS: Smokers (n = 94) from 26 states were enrolled (mean age 36, 56% female). INTERVENTION AND COMPARATOR: Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output (n = 48; abstinent contingent group, AC), or based on submitting CO samples (n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. MEASURES: The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. FINDINGS: Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = -10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. CONCLUSIONS: A contingency management/financial incentive program delivered via the internet improved short-term abstinence rates compared with an internet program without the incentives.

Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial.

BACKGROUND: Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers-and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the Web-based therapeutic education system (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this Web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. METHODS: Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n=72) or the Web-delivered TES intervention (n=69). Intervention effectiveness was assessed by evaluating changes in participants' knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. FINDINGS: Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. CONCLUSION: This study indicates that TES is as effective as HIV/disease prevention delivered by a prevention specialist. Because technology-based interventions such as TES have high fidelity, are inexpensive and scalable, and can be implemented in a wide variety of settings, they have the potential to greatly increase access to effective prevention programming.

A Web-Based Self-Management Program for Recent Combat Veterans With PTSD and Substance Misuse: Program Development and Veteran Feedback.

Combat veterans from the wars in Iraq and Afghanistan commonly experience posttraumatic stress disorder (PTSD) and substance use problems. In addition, these veterans often report significant barriers to receiving evidence-based mental health and substance use care, such as individual beliefs that treatment will be unhelpful, inconvenient, or that they should be able to handle their problems on their own. To increase access to treatment for this underserved population, a Web-based patient self-management program that teaches cognitive-behavioral therapy (CBT) skills to manage PTSD symptoms and substance misuse was developed. This paper describes and provides results from an iterative, multistage process for developing the Web-based program and seeks to inform clinicians in the field about the preferences of veterans for using a Web-based CBT program. Systematic feedback was gathered from (a) three expert clinicians in the field, (b) focus groups of combat veterans (n = 18), and (c) individual feedback sessions with combat veterans (n = 34). Clinician feedback led to the incorporation of motivational strategies to increase participant engagement and an optional module that guides written trauma exposure work. Focus group feedback guided the research team to frame the program in a strength-based approach and allows for maximum flexibility, adaptability, interactivity, and privacy for veterans. In individual feedback sessions, veterans generally found the program likable, easy to use, and relevant to their experiences; critiques of the program led to revised content meant to increase clarity and participant interest. Our findings provide specific guidance for clinicians who are interested in developing or providing technology-based treatment, including the need to gather feedback from an intervention's target audience when adapting a psychotherapeutic intervention and that the treatment must be highly interactive and private to engage clients.

Web-based behavioral treatment for substance use disorders as a partial replacement of standard methadone maintenance treatment.

This study is the first experimental trial to evaluate the effectiveness of a Web-based behavioral intervention when deployed in a model where it partially substituted for standard counseling in a community-based specialty addiction treatment program. New opioid-dependent intakes in methadone maintenance treatment (n=160) were randomly assigned for 12months to either: (1) standard treatment or (2) reduced standard treatment plus a Web-based psychosocial intervention, the Therapeutic Education System (TES). Results demonstrated that replacing a portion of standard treatment with TES resulted in significantly greater rates of objectively measured opioid abstinence (48% vs. 37% abstinence across all study weeks; F(1, 158)=5.90, p<.05 and 59% vs. 43% abstinence on weeks participants provided urine samples for testing; F(1, 158)=8.81, p<.01). This result was robust and was evident despite how opioid abstinence was operationally defined and evaluated. The potential implications for service delivery models within substance abuse treatment programs and other healthcare entities are discussed.

Internet-based contingency management to promote smoking cessation: a randomized controlled study.

We evaluated an Internet-based contingency management intervention to promote smoking cessation. Participants in the contingent group (n = 39) earned vouchers contingent on video confirmation of breath carbon monoxide (CO) ≤ 4 parts per million (ppm). Earnings for participants in the noncontingent group (n = 38) were independent of CO levels. Goals and feedback about smoking status were provided on participants' homepages. The median percentages of negative samples during the intervention in the noncontingent and contingent groups were 25% and 66.7%, respectively. There were no significant differences in absolute CO levels or abstinence at 3- and 6-month follow-ups. Compared to baseline, however, participants in both groups reduced CO by an estimated 15.6 ppm during the intervention phases. The results suggest that the contingency for negative COs promoted higher rates of abstinence during treatment, and that other elements of the system, such as feedback, frequent monitoring, and goals, reduced smoking.

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain.

OBJECTIVES: To describe the development of an interactive, web-based self-management intervention for opioid-treated, chronic pain patients with aberrant drug-related behavior. METHODS: Fifty-three chronic pain patients participated in either focus groups (N = 23) or individual feedback sessions (N = 30). Focus groups probed interest in and relevance of the planned content and structure of the program. Individual session participants reviewed draft program modules and provided feedback on acceptability, ease of use, and usefulness. Focus group transcripts were thematically analyzed, and summary statistics were performed on feedback data. RESULTS: Focus group participants stressed the need for additional pain management strategies and emphasized themes consistent with planned program content related to: 1) ambivalence about opioids; 2) reciprocal relationships among cognition, mood, and pain; 3) importance of recognizing physical limitations; and 4) effectiveness of goal setting for increasing motivation and functioning. Participants also offered insights on: 5) the loss of identity due to chronic pain; and 6) the desire to connect with pain peers to share strategies for managing daily life. Feedback session data demonstrate that participants believed that a web-based tool would be potentially useful and acceptable, and that exposure to program sections significantly increased participants' knowledge of key topics related to self-management of chronic pain. CONCLUSIONS: Results suggest the potential value of self-management for chronic pain patients and the potential acceptability of web-based delivery of intervention content. Focus group and feedback methodologies highlight the usefulness of including potential program users in intervention development.

Internet-based group contingency management to promote abstinence from cigarette smoking: a feasibility study.

BACKGROUND: In contingency management (CM) interventions, monetary consequences are contingent on evidence of drug abstinence. Typically, these consequences are contingent on individual performance. Consequences contingent on group performance may promote social support (e.g., praise). METHODS: Thus, to combine social support with the monetary incentives of CM, we integrated independent and interdependent group contingencies of reinforcement into an Internet-based intervention to promote smoking abstinence. Breath carbon monoxide (CO) measures were compared between treatment conditions and a baseline control condition. Thirteen participants were divided into 5 groups or "teams" (n=2-3 per team). Each participant submitted video recordings of CO measurement twice daily via the Internet. Teammates could monitor each other's progress and communicate with one another through an online peer support forum. During a 4-day tapering condition, vouchers exchangeable for goods were contingent on gradual reductions in breath CO. During a 10-day abstinence induction condition, vouchers were contingent on abstinence (CO≤4ppm). In both treatment conditions, concurrent independent and interdependent group contingencies were arranged (i.e., a mixed contingency arrangement). RESULTS: Less than 1% of CO samples submitted during baseline were≤4ppm, compared to 57% submitted during abstinence induction. Sixty-five percent of participants' comments on the online peer support forum were rated as positive by independent observers. Participants rated the intervention favorably on a treatment acceptability questionnaire. CONCLUSION: The results suggest that the intervention is feasible and acceptable for promoting abstinence from cigarette smoking.

An initial trial of a computerized behavioral intervention for cannabis use disorder.

The most potent outcomes for cannabis use disorders have been observed with a combination of three evidence-based interventions, motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and abstinence-based contingency-management (CM). Access to this intervention remains limited because of cost and service availability issues. This report describes the initial stages of a project designed to develop and test a computer-assisted version of MET/CBT/CM that could address many of the current barriers to its dissemination. A nonrandomized, 12-week comparison study assigned 38 adults seeking treatment for a cannabis use disorder to either therapist-delivered (n=22) or computer-delivered (n=16) MET/CBT/CM. Attendance, retention, and cannabis use outcomes did not differ significantly between groups, and there were no indications of superior outcomes favoring therapist delivery. Participants provided positive ratings of the computer-delivered sessions. These preliminary findings suggest that computer-assisted delivery of MET/CBT/CM is acceptable to outpatients and does not adversely impact compliance or outcomes achieved during treatment with MET/CBT/CM for cannabis use disorders. Assessment of post-treatment outcomes and replication in randomized trials are needed to determine reliability and longer term effects. As observed in a growing number of studies, computerized therapies have the potential to increase access to, reduce costs, and enhance fidelity of providing evidence-based treatments without sacrificing and possibly enhancing effectiveness.

Computer-assisted HIV prevention for youth with substance use disorders.

We developed an interactive, customizable, Web-based program focused on the prevention of HIV, sexually transmitted infections, and hepatitis among youth. Results from a randomized, controlled trial with youth in treatment for substance use demonstrated that this Web-based tool, when provided as an adjunct to an educator-delivered prevention intervention, increased accurate prevention knowledge, increased intentions to carefully choose partners, and was perceived as significantly more useful relative to the educator-delivered intervention when provided alone. Results suggest this Web-based program may be effective and engaging and may increase the adoption of effective HIV and disease prevention science for youth. Limitations are discussed.

Application of interactive, computer technology to adolescent substance abuse prevention and treatment.

This article provides an overview of several interactive, computer-based substance abuse-prevention and -treatment interventions that we have developed for adolescents, including an interactive substance abuse-prevention multimedia program for middle school-aged youth and a customizable program focused on prevention of HIV, hepatitis, and sexually transmitted infections among youth in substance abuse treatment. The content in these programs is grounded in a scientific understanding of the types of skills and information that are critical to effective prevention. The programs also use several evidence-based informational technologies that have been shown to be critical in effectively training key skills and information. Our evaluations to date have underscored the effectiveness of these programs in producing desired health-behavior change. Applying information technologies to the delivery of science-based interventions may allow for unique opportunities to provide widespread dissemination of cost-effective interventions with consistency and in a manner that is engaging and acceptable to youth.

A web-based therapeutic workplace for the treatment of drug addiction and chronic unemployment.

This article describes a Web-based therapeutic workplace intervention designed to promote heroin and cocaine abstinence and train and employ participants as data entry operators. Patients are paid to participate in training and then to perform data entry jobs in a therapeutic workplace business. Salary is linked to abstinence by requiring patients to provide drug-free urine samples to gain access to the workplace. Prior data show that a prototype of the intervention could promote drug abstinence. Preliminary data on the Web-based intervention suggest that it should be able to teach adults with histories of chronic unemployment and drug addiction to become skilled data entry operators in about 3 to 6 months. Early experience in the business provides preliminary evidence that it might become financially successful. The therapeutic workplace intervention may serve as an effective and practical long-term treatment for chronic unemployment and heroin and cocaine addiction.

Development of immune response that protects mice from viral pneumonitis after a single intranasal immunization with influenza A virus and nanoemulsion.

Nanoemulsion, a water-in-oil formulation stabilized by small amounts of surfactant, is non-toxic to mucous membranes and produces biocidal activity against enveloped viruses. We evaluated nanoemulsion as an adjuvant for mucosal influenza vaccines. Mice (C3H/HeNHsd strain) were vaccinated intranasally with 5 x 10(5) plaque forming units (pfu) of influenza A virus (Ann Arbor/6/60 strain) and a nanoemulsion mixture. The mice were challenged on day 21 after immunization with an intranasal lethal dose of 2 x 10(5) pfu of virus. Animals vaccinated with the influenza A/nanoemulsion mixture were completely protected against infection, while animals vaccinated with either formaldehyde-killed virus or nanoemulsion alone developed viral pneumonitis and died by day 6 after the challenge. Mice vaccinated with virus/nanoemulsion mixture had rapid cytokine responses followed by high levels of specific anti-influenza immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies. Specificity of the immune response was confirmed by assessment of the proliferation and cytokine production in splenocytes. This paper demonstrates that nanoemulsion can be employed as a non-toxic mucosal adjuvant for influenza virus vaccine.