Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial.

OBJECTIVE: Mental health complaints are prevalent among people with epilepsy, yet there are major barriers that prevent access to psychological care, including high out-of-pocket costs and a lack of accessible specialized services. The purpose of the current study is to examine the comparative efficacy, acceptability, cost-effectiveness, and long-term outcomes of a digital psychological intervention when delivered under two models of care (i.e., guided vs. unguided) in supporting the mental health and functioning of adults with epilepsy. METHOD: Approximately 375 participants across Australia will be enrolled. Eligible participants will have a confirmed diagnosis of epilepsy, experience difficulties with their emotional health, be at least 18 years of age, and live in Australia. Participants will be randomized (2:2:1) to receive the Wellbeing Neuro Course, a 10-week internet-delivered program, with (i.e., guided) or without guidance by a mental health clinician (i.e., unguided), or be allocated to a treatment-as-usual waiting-list control group. Participants will complete online questionnaires at pre-, post-treatment, and 3- and 12-month follow-up and consent to have their data linked to their medical records to capture healthcare system resource use and costs. ANALYSIS: Primary outcome measures will be symptoms of depression and anxiety. A cost-utility analysis will be undertaken using the Australian healthcare system perspective and according to current economic evaluation guidelines. Resource use and costs to the healthcare system during the study period will be captured via data linkage to relevant administrative datasets in Australia. SIGNIFICANCE: The results of this trial will provide important data concerning the relative outcomes of these different models of care and will inform the integration of digital psychological interventions translation into healthcare services. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of Macquarie University approved the proposed study (Reference No: 520231325151475). The results will be disseminated through peer-reviewed publication(s). ANZCTR TRIAL REGISTRATION NUMBER: ACTRN12623001327673. PLAIN LANGUAGE SUMMARY: This study seeks to find out if a 10-week online psychological treatment can improve the mental health and well-being of Australian adults with epilepsy. Around 375 participants will be randomly assigned to different groups: one will receive treatment with guidance from mental health clinician (guided group), one without guidance (unguided group), and one starting later (waiting control group). All participants will fill out the same outcome measures online. The main goal of this research is to compare these groups and assess how well the treatment works in improving mental health outcomes.

Predictors of functional impairment at assessment and functional improvement after treatment at a national digital mental health service.

Mental disorders are associated with impairment to daily functioning, which affects both the individual and society. Despite this, most research on treatment outcome only report symptom change. Self-reported days out of role (DOR) is a simple measure of functional impairment used in many population studies. The current study sought to report on the degree of functional impairment measured by DOR in a clinical sample at assessment, the factors associated with this impairment, the predictors of functional improvement after treatment and the relationship between symptomatic and functional change. Using a prospective uncontrolled observational cohort study design with a sample of 17,813 patients accessing a digital mental health service (DMHS), we examined self-reported demographic, psychosocial and clinical data. Using a series of univariate regression models and multivariate classification algorithms, we found that baseline DOR was associated with age, employment and relationship status, symptom severity, symptom chronicity and with the presence of several psychosocial difficulties. Baseline DOR was best predicted by older age, disability payments, higher symptom severity and increasing number of endorsed psychosocial difficulties (R2 = 32.7 %). Forty-one per cent of the sample experienced a >50 % or greater reduction in DOR following treatment. Those who were separated, unemployed or on disability payments, or with severe and chronic depression, experienced the greatest reductions in DOR after treatment. Changes in functioning were independent of changes in symptoms, highlighting the importance of functional impairment as a treatment outcome. This study found that many of the patients who access DMHS have significant levels of functional impairment, a large proportion obtain functional improvement after treatment, and improvement in function after treatment was independent of improvement in symptoms.

The Pain Course: a randomised controlled trial and economic evaluation of an internet-delivered pain management program.

ABSTRACT: There is interest in the potential of Internet-delivered programs to cost-effectively increase access to pain management for people with chronic pain. However, few large-scale clinical and economic evaluations have been undertaken. Using a randomised controlled trial design, the current study (n = 659) examined the clinical efficacy, cost-effectiveness, and cost utility of an Internet-delivered pain management program for people with mixed chronic pain conditions when delivered with optional clinician support. The treatment group reported significant improvements in disability, depression, anxiety, average pain intensity, and quality-adjusted life years (QALYs), compared with control, and exhibited relatively high levels of treatment engagement and satisfaction. Each additional clinical improvement (defined as ≥ 30% improvement) produced by the intervention, over control, was associated with a cost of $48, $27, $38, and $83 for disability, depression, anxiety, and average pain intensity, respectively. Gaining one QALY was associated with a cost of $152 or $11,910 per QALY when an 80% probability criterion for cost utility was applied. The program itself was associated a relatively small, fixed, cost per patient but was not cost saving over the brief intervention period. The findings support the clinical efficacy and cost-effectiveness of Internet-delivered programs with "on demand" clinician support as a way to increase access to pain management. Key limitations of the current study include the use of a waitlist-control group, a short follow-up period, and the focus on governmental healthcare costs. Further evaluation of these programs is necessary if they are scaled up and offered as routine care.

A Cost-effectiveness Analysis of an Internet-delivered Pain Management Program Delivered With Different Levels of Clinician Support: Results From a Randomised Controlled Trial.

There is growing interest in the potential of internet-delivered pain management programs (PMPs) to increase access to care for people with chronic pain. However, very few economic evaluations of these interventions have been reported. Using existing data, the current study examined the cost-effectiveness of an internet-delivered PMP for a mixed group chronic pain patients (n = 490) provided with different levels of clinician support. The findings indicated that each additional clinical outcome (defined as a ≥ 30% reduction in disability, depression, anxiety, and pain) was associated with cost-savings when the intervention was provided in a self-guided format (ICER range: -$404--$808 AUD) or an optional-guided format (ICER range: -$314--$541 AUD), and a relatively small fixed cost when provided in the clinician-guided format (ICER range: $88-$225 AUD). The results were driven by a reduction in service use costs among the treatment groups, which offset the costs of providing the internet-delivered PMP in the self-guided and optional-guided formats. The same general pattern of results was found when more stringent clinical outcomes (defined as a ≥ 50% reduction) were employed. These findings suggest that carefully developed and administered internet-delivered PMPs, provided with different levels of clinician support, can be highly cost effective for patients with a broad range of pain conditions. PERSPECTIVE: This study examines the cost-effectiveness of an internet-delivered PMP provided to adults with a broad range of chronic pain conditions. Evidence of cost-effectiveness was found across a broad range of clinical outcomes and with different levels of clinician support.

Rapid report: Early demand, profiles and concerns of mental health users during the coronavirus (COVID-19) pandemic.

BACKGROUND: Trends in contact with a high volume national digital mental health service (DMHS), the MindSpot Clinic, provide a unique opportunity to assess the mental health effects of the COVID-19 pandemic. METHODS: Three methods were used to assess changes in responses to COVID-19. First, website visits and call centre traffic were compared across two time periods: the "comparison period" (1 to 28 September 2019), and during the early weeks of the "COVID-19 pandemic" (19 March to 15 April 2020). Second, demographic and symptom data were compared across all patients who started an assessment during the comparison (n = 1650) and the COVID-19 period (n = 1668). Third, responses to questions about the impact of COVID-19 introduced to the assessment from 19 March 2020, and reports from treating therapists were examined. RESULTS: There was an 89% increase in website visits and a 90% increase in telephone calls to the clinic in the early COVID-19 period compared to the comparison period. There was a higher proportion of females in the COVID-19 sample (76.9% vs. 72.9%), and a lower proportion reported being in employment (52.8% vs. 60.8%). There was a small but significant increase in the severity of anxiety symptoms, and an increase in the number of people reporting recent onset of anxiety and depression. However, there were no differences between groups in severity of symptoms of distress or depression. Most people (94%) reported concern about the impact of COVID-19, and 88% reported making changes in lifestyle. Older adults had higher levels of concern about COVID-19. Therapists reported that patients were concerned about how to access testing, manage quarantine, financial security and the effect of social isolation. CONCLUSIONS: COVID-19 has resulted in a significant increase in contact with an established DMHS, but we have not yet detected increases in baseline symptom severity. With the prospect of prolonged restriction of movement, DMHS such as MindSpot could play an important role in both providing clinical services and monitoring the mental health of the population.

The Pain Course: a randomised controlled trial examining an internet-delivered pain management program when provided with different levels of clinician support.

The present study evaluated an internet-delivered pain management program, the Pain Course, when provided with different levels of clinician support. Participants (n = 490) were randomised to 1 of 4 groups: (1) Regular Contact (n = 143), (2) Optional Contact (n = 141), (3) No Contact (n = 131), and (4) a treatment-as-usual Waitlist Control Group (n = 75). The treatment program was based on the principles of cognitive behaviour therapy and comprised 5 internet-delivered lessons provided over 8 weeks. The 3 Treatment Groups reported significant improvements (between-group Cohen's d; avg. reduction) in disability (ds ≥ 0.50; avg. reduction ≥ 18%), anxiety (ds ≥ 0.44; avg. reduction ≥ 32%), depression (ds ≥ 0.73; avg. reduction ≥ 36%), and average pain (ds ≥ 0.30; avg. reduction ≥ 12%) immediately posttreatment, which were sustained at or further improved to 3-month follow-up. High treatment completion rates and levels of satisfaction were reported, and no marked or consistent differences were observed between the Treatment Groups. The mean clinician time per participant was 67.69 minutes (SD = 33.50), 12.85 minutes (SD = 24.61), and 5.44 minutes (SD = 12.38) for those receiving regular contact, the option of contact, and no clinical contact, respectively. These results highlight the very significant public health potential of carefully designed and administered internet-delivered pain management programs and indicate that these programs can be successfully administered with several levels of clinical support.