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A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.

ABSTRACT: Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 (b?=?-2.75, 95% CI -4.00, -1.50) and GAD-7 (b?=?-2.79, 95% CI -4.00, -1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm's outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.

SUBMITTER: Richards D

PROVIDER: S-EPMC7295750 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.

Richards Derek D Enrique Angel A Eilert Nora N Franklin Matthew M Palacios Jorge J Duffy Daniel D Earley Caroline C Chapman Judith J Jell Grace G Sollesse Sarah S Timulak Ladislav L

NPJ digital medicine 20200615

Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: w ...[more]

PMID: 32566763

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Project description:BackgroundAlcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors.ObjectiveThis study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors.MethodsA health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse-Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon.ResultsAlcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI -7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI -0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US $74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US $23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ -1158, 95% CI -1609 to -781).ConclusionsAt 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs.Trial registrationNetherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433.International registered report identifier (irrid)RR2-10.1186/s12885-018-4206-z.

Project description:BackgroundDepression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.MethodsThe study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis.DiscussionThis study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services.Trial registrationCurrent Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124 . Web: http://www.isrctn.com/ISRCTN91967124 . Clinicaltrials.gov : NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Project description:PurposeSecondary prevention of coronary artery disease, self-management behavior, and blood pressure control are important to cardiovascular event prevention and promotion of quality of life (QOL), but they are underutilized. The purpose of this study was to investigate the effects of a self-efficacy theory-based health information technology intervention implemented through blood control and patient self-management.DesignA clinical randomized waitlist-controlled trial.MethodsThe study was conducted at a medical center in Taipei, Taiwan. A total of 60 subjects were randomly assigned to either the immediate intervention (experimental) group or the waitlist control group. The primary endpoint was systolic blood pressure at 3 months; secondary end points included self-management behavior and QOL. Treatment for the immediate intervention group lasted 3 months, while the waitlist control group received routine care for the first 3 months, at which point they crossed over to the intervention arm and received the same intervention as the experimental group for another 3 months. Both groups were evaluated by questionnaires and physiological measurements at both 3 and 6 months postadmission. The results were analyzed using generalized estimating equations.ResultsSystolic blood pressure significantly improved for the intervention group participants at 3 months, when there was also significant improvement in self-management behavior and QOL. There was no significant or appreciable effect of time spent in the waitlist condition, with treatments in the two conditions being similarly effective.ConclusionThe use of a theory-based health information technology treatment compared with usual care resulted in a significant improvement in systolic blood pressure, self-management behavior, and QOL in patients with coronary artery disease.Clinical relevanceThis treatment would be a useful strategy for clinical care of cardiovascular disease patients, improving their disease self-management. It also may help guide further digital health care strategies during the COVID-19 pandemic.

Project description:The COVID-19 pandemic has amplified mental health problems and highlighted inequitable gaps in care worldwide. In response there has been an explosion of digital interventions such as smartphone applications ("apps") to extend care. The objective of this trial is to evaluate the effectiveness and cost-effectiveness of a digital depression intervention (VMood), delivered via a smartphone app. VMood is adapted from an in-person intervention that was delivered by non-specialist providers and shown to be effective in the Vietnamese context in our previous trial (2016-2019). A stepped-wedge, randomized controlled trial will be conducted across eight provinces in Vietnam. Adults aged 18 years and over will be recruited through community-based primary care centres and screened for depression using the embedded Patient Health Questionnaire-9 (primary outcome measure). Participants scoring 10-19, indicating depression caseness, will be randomly allocated to the intervention or control group until the target of 336 is reached. Secondary outcome measures will examine the effect of the intervention on commonly co-occuring anxiety, quality of life and work productivity, along with use of alcohol and tobacco products. Assessments will be administered through an online survey platform (REDCap) at baseline, and at every 3 months until 3 months post-intervention. Intervention-group participants will receive VMood for a 3-month period, with online support provided by social workers. Control-group participants will receive a limited version of the app until they cross into the intervention group. Generalized Linear Mixed-effect Models for clustered measures will be used for all outcomes data. We will conduct a cost-effectiveness analysis alongside the trial to capture VMood's costs and benefits. This trial will provide evidence on the effectiveness and cost-effectiveness of a digital mental health intervention adapted from an in-person intervention. This trial will also contribute important information to the growing and promising field of digital mental health. Trail regulation. Registered at ClinicalTrials.gov, identifier [NCT05783531].

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A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.

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A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.

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