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.

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.

Involvement in compensation litigation and outcome from an online pain management program.

OBJECTIVE: To report on the effect of involvement in civil litigation on outcome for patients enrolled in a validated Internet-delivered pain management program, the Pain Course. RESEARCH METHOD: Data from a randomized controlled trial (RCT) on the effect of varying levels of clinician support was used to examine the effect of involvement in civil litigation on outcome in a free online pain management course. Outcome measures were changes in scores on self-report questionnaires for depression, anxiety, and disability (PHQ-9, GAD-7, and RMDQ) from baseline to 3-month follow-up for those still involved in litigation and those who had completed litigation, compared with outcomes for those who did not report involvement in litigation. The use of regular and as-required opioid medication at assessment and follow-up were also compared. RESULTS: Of the 397 patients enrolled in the pain course, 290 (73.0%) were not involved in litigation, 80 (20.2%) reported involvement in litigation that had been resolved and 27 (6.8%) reported ongoing litigation. Those still involved in litigation had the highest scores on depression scales and the highest rate of opioid use. The completion rates and symptom improvement was lower among current litigants but were still positive, with effect sizes on the outcome measures of between 0.56 and 0.73, as well as a reduction in the use of opioids. CONCLUSIONS: Current involvement in compensation litigation was associated with lower treatment completion and less symptom improvement. Nevertheless, the positive findings have significant implications for people involved in workers' compensation and other litigation who report pain as one of their symptoms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

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.

Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of depression: a randomized controlled trial.

UNLABELLED: Depression is a common and significant health problem among older adults. Unfortunately, while effective psychological treatments exist, few older adults access treatment. The aim of the present randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of a therapist-guided internet-delivered cognitive behavior therapy (iCBT) intervention for Australian adults over 60 years of age with symptoms of depression. Participants were randomly allocated to either a treatment group (n=29) or a delayed-treatment waitlist control group (n=25). Twenty-seven treatment group participants started the iCBT treatment and 70% completed the treatment within the 8-week course, with 85% of participants providing data at posttreatment. Treatment comprised an online 5-lesson iCBT course with brief weekly contact with a clinical psychologist, delivered over 8 weeks. The primary outcome measure was the Patient Health Questionnaire-9 Item (PHQ-9), a measure of symptoms and severity of depression. Significantly lower scores on the PHQ-9 (Cohen's d=2.08; 95% CI: 1.38 - 2.72) and on a measure of anxiety (Generalized Anxiety Disorder-7 Item) (Cohen's d=1.22; 95% CI: 0.61 - 1.79) were observed in the treatment group compared to the control group at posttreatment. The treatment group maintained these lower scores at the 3-month and 12-month follow-up time points and the iCBT treatment was rated as acceptable by participants. The treatment group had slightly higher Quality-Adjusted Life-Years (QALYs) than the control group at posttreatment (estimate: 0.012; 95% CI: 0.004 to 0.020) and, while being a higher cost (estimate $52.9l 95% CI: -23.8 to 128.2), the intervention was cost-effective according to commonly used willingness-to-pay thresholds in Australia. The results support the potential efficacy and cost-effectiveness of therapist-guided iCBT as a treatment for older adults with symptoms of depression. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12611000927921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343384.

Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial.

UNLABELLED: There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohen's d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohen's d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs ($92.2; 95% CI: $38.7 to $149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909.