Identifying factors associated with user retention and outcomes of a digital intervention for substance use disorder: a retrospective analysis of real-world data.

Objectives: Successful delivery of digital health interventions is affected by multiple real-world factors. These factors may be identified in routinely collected, ecologically valid data from these interventions. We propose ideas for exploring these data, focusing on interventions targeting complex, comorbid conditions. Materials and Methods: This study retrospectively explores pre-post data collected between 2016 and 2019 from users of digital cognitive behavioral therapy (CBT)-containing psychoeducation and practical exercises-for substance use disorder (SUD) at UK addiction services. To identify factors associated with heterogenous user responses to the technology, we employed multivariable and multivariate regressions and random forest models of user-reported questionnaire data. Results: The dataset contained information from 14 078 individuals of which 12 529 reported complete data at baseline and 2925 did so again after engagement with the CBT. Ninety-three percent screened positive for dependence on 1 of 43 substances at baseline, and 73% screened positive for anxiety or depression. Despite pre-post improvements independent of user sociodemographics, women reported more frequent and persistent symptoms of SUD, anxiety, and depression. Retention-minimum 2 use events recorded-was associated more with deployment environment than user characteristics. Prediction accuracy of post-engagement outcomes was acceptable (Area Under Curve [AUC]: 0.74-0.79), depending non-trivially on user characteristics. Discussion: Traditionally, performance of digital health interventions is determined in controlled trials. Our analysis showcases multivariate models with which real-world data from these interventions can be explored and sources of user heterogeneity in retention and symptom reduction uncovered. Conclusion: Real-world data from digital health interventions contain information on natural user-technology interactions which could enrich results from controlled trials.

Examining outcomes for service users accessing the Breaking Free Online computer-assisted therapy program for substance use disorders via a 'telehealth' approach: protocol for a two arm, parallel group randomized controlled trial.

BACKGROUND: Breaking Free Online (BFO), a computer-assisted therapy (CAT) program for substance use disorders (SUD), has been available across UK treatment services for the past decade and has demonstrated efficacy. The Covid-19 pandemic has contributed to digital and 'telehealth' approaches to healthcare delivery becoming more common and accepted, and has in parallel, increased numbers of referrals to SUD services because of the impact pandemic-related stress has had on substance using habits in the general population. Digital and telehealth approaches, such as BFO, have the potential to support the treatment system to meet this increased demand for SUD services. METHODS: Parallel-group randomized controlled trial of eight-week BFO as an adjunct to standard treatment for SUD, in comparison to standard treatment only, at a National Health Service (NHS) Mental Health Trust in North-West England. Participants will be service users aged 18 years and over with demonstrable SUD for at least 12-months. Interventional and control groups will be compared on multiple measures from baseline to post-treatment assessment at eight-weeks, and then three and six-months follow-up. Primary outcome will be self-reported substance use, with secondary outcomes being standardized assessments of substance dependence, mental health, biopsychosocial functioning and quality of life. DISCUSSION: This study will examine whether BFO and telehealth support, when delivered as an adjunct to standard SUD interventions, improves outcomes for services users receiving NHS SUD treatment. Findings from the study will be used to inform both developments to the BFO program and guidance around augmenting the delivery of CAT programs via telehealth. Trial registration registered with ISRCTN on 25th May 2021-registration number: 13694016. PROTOCOL VERSION: 3.0 05th April 2022. TRIAL STATUS: This trial is currently open to recruitment-estimated to be completed in May 2023.

On the Difficulty of Predicting Engagement with Digital Health for Substance Use.

Digital interventions can be an important instrument in treating substance use disorder. However, most digital mental health interventions suffer from early, frequent user dropout. Early prediction of engagement would allow identification of individuals whose engagement with digital interventions may be too limited to support behaviour change, and subsequently offering them support. To investigate this, we used machine learning models to predict different metrics of real-world engagement with a digital cognitive behavioural therapy intervention widely available in UK addiction services. Our predictor set consisted of baseline data from routinely-collected standardised psychometric measures. Areas under the ROC curve, and correlations between predicted and observed values indicated that baseline data do not contain sufficient information about individual patterns of engagement.

Peer support and online cognitive behavioural therapy for substance use concerns: protocol for a randomised controlled trial.

INTRODUCTION: Hazardous alcohol and drug use is associated with substantial morbidity, mortality and societal cost worldwide. Yet, only a minority of those struggling with substance use concerns receive specialised services. Numerous barriers to care exist, highlighting the need for scalable and engaging treatment alternatives. Online interventions have exhibited promise in the reduction of substance use, although studies to date highlight the key importance of patient engagement to optimise clinical outcomes. Peer support may provide a way to engage patients using online interventions. The goal of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online (BFO), an online cognitive-behavioural intervention for substance use, delivered with and without peer support. METHODS AND ANALYSIS: A total of 225 outpatients receiving standard care will be randomised to receive clinical monitoring with group peer support, with BFO alone, or with BFO with individual peer support, in an 8-week trial with a 6-month follow-up. The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement and cost-effectiveness. Mixed effects models will be used to test hypotheses, and thematic analysis of qualitative data will be undertaken. ETHICS AND DISSEMINATION: The protocol has received approval by the Centre for Addiction and Mental Health Research Ethics Board. Results will help to optimise the effectiveness of structured online substance use interventions provided as an adjunct to standard care in hospital-based treatment programmes. Findings will be disseminated through presentations and publications to scholarly and knowledge user audiences. TRIAL REGISTRATION NUMBER: NCT05127733.

Associations between psychosocial risk factors, and changes in substance dependence and psychosocial functioning, during engagement with digital cognitive behavioral therapy for methamphetamine use: use of 'Breaking Free from Substance Abuse' by incarcerated people during the COVID-19 pandemic.

BACKGROUND: Methamphetamine use can be associated with involvement with correctional services and incarceration. Traditionally, treatments for methamphetamine use have been delivered in-person - however, lockdowns initiated during the COVID-19 pandemic significantly reduced access to such in-person support in prisons. Therefore, in May 2020 a digital cognitive-behavioral therapy (CBT) program for substance use disorders - 'Breaking Free from Substance Abuse' - was made available across prisons in Ohio in order to meet this treatment gap. This represents the first time this digital CBT intervention has been made widely available to incarcerated people residing in prisons or jails in the United States (US). This was a within-subjects study using data from 2187 Ohio prison residents who engaged with this digital CBT program to address their methamphetamine use. RESULTS: Participants reported multiple psychosocial risk factors, including moderate to severe substance dependence, depression and anxiety; interpersonal conflict; aggressive behavior; paranoia; and difficulties with work, education and accommodation. Significant reductions in substance dependence, depression/anxiety and biopsychosocial impairment, and improvements in quality of life, were identified in the sample. Risk factors were associated with less positive outcomes, specifically interpersonal conflict and poor mental health. Completion of specific components of the program were associated with more positive outcomes - a dose response was also identified. CONCLUSIONS: Digital CBT can be delivered in secure US correctional settings and may help to fill unmet needs for in-person treatment. Specifically, this digital CBT program may support incarcerated individuals to address methamphetamine use, with outcomes being associated with psychosocial risk factors and program engagement.

Examining correlates of cannabis users' engagement with a digital intervention for substance use disorder: An observational study of clients in UK services delivering Breaking Free Online.

BACKGROUND: Cannabis is among the most widely used drugs, with the literature demonstrating that cannabis use disorder (CUD) may be more prevalent than previously thought. Research should explore novel approaches to behavioral support to meet treatment need, including computer-assisted therapies such as Breaking Free Online (BFO). This study aimed to understand how participants' baseline sociodemographic and clinical characteristics are associated with engagement with BFO, and how both participants' characteristics and their engagement may be associated with cannabis use and biopsychosocial functioning at follow-up. METHODS: An observational study with 1830 individuals presenting to UK-based publicly funded treatment services who reported cannabis as their primary problem substance and engaged with BFO as a self-directed intervention. RESULTS: Moderate-severe depression/anxiety (51%) and elevated severity of cannabis dependence scores (39%) characterized the baseline sample. Women demonstrated greater clinical complexity at baseline than men. Baseline mental health and biopsychosocial functioning were associated with whether participants completed a follow-up assessment. Among 460 participants who completed a follow-up assessment, intervention engagement was positively associated with self-reported quality of life and biopsychosocial functioning at follow-up. CONCLUSIONS: Cannabis users demonstrated substantial clinical complexity at baseline, with depression/anxiety and biopsychosocial functioning being associated with BFO engagement. Greater BFO engagement was also associated with better quality of life and biopsychosocial functioning at follow-up. Some groups, including those with greater mental health and biopsychosocial impairment at baseline and women, may require support to engage with BFO to maximize clinical benefits.

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment.

Background: Increasing rates of opioid-related overdose have been identified globally. Treatment for opioid use disorders (OUD) includes medications for opioid use disorder (MOUD) alongside behavioral support. Novel approaches to behavioral support should be explored, including computer-assisted therapy (CAT) programs.Objectives: Examine differences between baseline and post-treatment measures of opioid use and biopsychosocial functioning for individuals with OUD engaging with the CAT program 'Breaking Free Online,' and the extent to which participant characteristics may be associated with post-treatment measures.Methods: 1107 individuals engaged with CAT and provided baseline and post-treatment data - 724 (65.4%) were male, 383 (34.6%) were female.Results: Significant differences between baseline and post-treatment measures were identified (all p <.0001, effect sizes range:15 -.50). Participant characteristics were associated with post-treatment measures of opioid use, opioid dependence, mental health issues, quality of life, and biopsychosocial impairment (all p <.0001). An aggregated consensus measure of clinical impairment was found to be associated with changes in opioid use and post-treatment biopsychosocial functioning measures, with those participants with greater baseline clinical impairment demonstrating a greater magnitude of improvement from baseline to post-treatment than those with lower clinical impairment.Conclusion: CAT may reduce opioid use and improve biopsychosocial functioning in individuals with OUD. CAT could therefore provide a solution to the global opioid crisis if delivered as combination behavioral support alongside MOUD. Findings also indicate that it may be important for treatment systems to identify individuals with psychosocial complexity who might require behavioral support and MOUD.

Are Computer-Based Treatment Programs Effective at Reducing Symptoms of Substance Misuse and Mental Health Difficulties Within Adults? A Systematic Review.

Objective: Comorbid substance misuse and mental health difficulties are recognized as a leading contributor to disease burden worldwide. Amid cuts to health care services, computer-based interventions may provide support for patients experiencing these difficulties. The aims of this systematic review were to identify and investigate the efficacy of these computer-based interventions at improving substance misuse and mental health outcomes.Methods: A systematic search was conducted of CINAHL Plus, PsycARTICLES, PsycINFO, Medline, Web of Science, and the Cochrane Library. Gray literature was also searched for relevant papers. Data were extracted from 33 papers, which met eligibility criteria by reporting a computer-based intervention designed to treat substance misuse and mental health in adults. Quality assessments were conducted on these papers.Results: Computer-based interventions generally led to an improvement of substance misuse and mental health outcomes within groups and when compared against waitlist control and psychoeducation. Computer-based interventions were effective at improving dual diagnosis outcomes, and improvements to mental health outcomes specifically were maintained for up to nine months. However, the combined effect of computer-based interventions and therapist support was found to be more effective than the effects of computer-based interventions alone.Conclusions: Many papers were limited by high attrition rates commonly attributed to "digital" interventions. Future research should consider systematically recruiting a range of participants, including those potentially affected by the digital divide, and incorporating methods within research to maintain engagement. This review was also limited by the heterogeneity of the papers reported, many of which differed between targeting dual diagnosis and targeting either substance misuse or mental health respectively, with outcomes investigating other difficulties out of curiosity.

Offenders' perceptions of the UK prison smoking ban.

PURPOSE: Despite overall reductions in levels of smoking in the UK, rates of offender smoking remain high. In 2016, it was announced that prisons in England and Wales would gradually introduce a smoking ban. The purpose of this paper is to explore offenders' perceptions around the upcoming smoking ban. DESIGN/METHODOLOGY/APPROACH: A total of eight focus groups were conducted in four prisons across the North of England. Both smoking and non-smoking offenders participated in the focus groups, and thematic analysis was used to explore the findings. FINDINGS: Themes generated from the data were "freedom and rights", "the prison environment" and "guiding support". Participants discussed how the smoking ban was viewed as a punishment and restricted their freedom, with perceptions as to why the ban was being implemented centring around others trying to control them. Participants expressed concerns around the financial implications of the smoking ban on already stretched prison resources. Participants also recommended improving the nicotine replacement therapy on offer, and increasing the range of leisure activities within the prison to prepare for the smoking ban. ORIGINALITY/VALUE: Overall, it was apparent that participants' awareness of the smoking ban was generally poor. It is recommended that offenders need to be made more aware of the smoking cessation support they will receive and given the opportunity to ask questions about the smoking ban. Increasing offenders' awareness of the ban may reduce stress associated with a perceived lack of choice around their smoking behaviours.

Protocol for a randomized controlled trial of the Breaking Free Online Health and Justice program for substance misuse in prison settings.

BACKGROUND: Substance misuse, including problematic drug and alcohol use, are significant issues in society that can have multiple detrimental effects. Many people access support for their substance misuse during prison sentences, due to the associations between substance misuse and offending, and the high proportion of the prison population who have drug and alcohol issues. Breaking Free Online Health and Justice is a computer-assisted therapy program that has been developed to support substance-involved offenders to address their substance misuse and associated offending within prison settings. METHODS: This will be a parallel-group randomized controlled trial of 4-week Breaking Free Online Health and Justice program as an adjunct to standard treatment for substance misuse, in comparison to standard treatment only, in a male Category D open prison. Interventional and control groups will be compared in terms of the changes in their scores on multiple measures from baseline to post-treatment assessment at 4-weeks, and then 3- and 6-months follow-up. Participants will be adult male offenders serving sentences in prison in England who have demonstrable difficulties with drugs and/or alcohol for at least the past 12-months. The primary outcome measure will be self-reported substance misuse, with secondary outcomes being standardized psychometric assessments of substance dependence, mental health, biopsychosocial functioning, quality of life and post-release offending. Other secondary measures will include frequency of completion of specific intervention strategies in the program. DISCUSSION: This study will examine whether Breaking Free Online Health and Justice as an adjunct to standard substance misuse interventions in prisons, improves outcomes for substance-involved offenders receiving interventions in custodial settings. Findings from the study will be used to inform further developments of the program and potential improvements to custodial treatment. TRIALS REGISTRATION: ISRCTN09846981 .