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.

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.