Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study.
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SUBMITTER: Grafe V
PROVIDER: S-EPMC6734272 | biostudies-literature | 2019 Jun
REPOSITORIES: biostudies-literature
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Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study.
Gräfe Viola V Berger Thomas T Hautzinger Martin M Hohagen Fritz F Lutz Wolfgang W Meyer Björn B Moritz Steffen S Rose Matthias M Schröder Johanna J Späth Christina C Klein Jan Philipp JP Greiner Wolfgang W
Health economics review 20190607 1
<h4>Background</h4>Depression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention "deprexis" in reducing disease-related costs.<h4>Methods</h4>Participants with mild to moderate depressive symptoms were recruited and randomized to either a 12-week web-based intervention (deprexis) in addition to ...[more]
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Project description:BACKGROUND:Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE:To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS:A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS:In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS:Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).
| S-EPMC5244034 | biostudies-other
Project description:BACKGROUND:Depressive disorders often remain undiagnosed or are treated inadequately. Online-based programs may reduce the present treatment gap for depressive disorders and reduce disease-related costs. This study aimed to examine the potential of the internet intervention "deprexis" to reduce the total costs of statutory health insurance. Changes in depression severity, health-related quality of life and impairment in functioning were also examined. METHOD:A total of 3805 participants with, at minimum, mild depressive symptoms were randomized to either a 12-week online intervention (deprexis) or a control condition. The primary outcome measure was statutory health insurance costs, estimated using health insurers' administrative data. Secondary outcomes were: depression severity, health-related quality of life, and impairment in functioning; assessed on patient's self-report at baseline, post-treatment, and three-months' and nine-months' follow-up. RESULTS:In both groups, total costs of statutory health insurance decreased during the study period, but changes from baseline differed significantly. In the intervention group total costs decreased by 32% from 3139€ per year at baseline to 2119€ in the study year (vs. a mean reduction in total costs of 13% in the control group). In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life. CONCLUSION:The study underlines the potential of innovative internet intervention programs in treating depressive disorders. The results suggest that the use of deprexis over a period of 12?weeks leads to a significant improvement in symptoms with a simultaneous reduction in the costs of statutory health insurance.
| S-EPMC7298860 | biostudies-literature
Project description:BackgroundWeb-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).ObjectiveThe aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.MethodsWe assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.ResultsWhile groups did not differ regarding the change in depression from t0 to t1 (ηp2=.007, P=.746) or t0 to t2 (ηp2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (ηp2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (ηp2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.ConclusionsAlthough we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registrationDKRS (#DRKS00011562).
| S-EPMC7146239 | biostudies-literature
Project description:BackgroundDepression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited.ObjectiveThis study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence.MethodsIn an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed.ResultsOf the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07).ConclusionsThe Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw).
| S-EPMC5491897 | biostudies-literature
Project description:BACKGROUND:Work-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant. OBJECTIVE:The aim of this study was to assess the cost-effectiveness of a guided iSMI for employees. METHODS:A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale?22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000). RESULTS:When the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained. CONCLUSIONS:Offering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC. TRIAL REGISTRATION:German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1186/1471-2458-13-655.
| S-EPMC6707573 | biostudies-literature
Project description:BackgroundExperience sampling, a method for real-time self-monitoring of affective experiences, holds opportunities for person-tailored treatment. By focussing on dynamic patterns of positive affect, experience sampling method interventions (ESM-I) accommodate strategies to enhance personalized treatment of depression-at potentially low-costs. This study aimed to investigate the cost-effectiveness of an experience sampling method intervention in patients with depression, from a societal perspective.MethodsParticipants were recruited between January 2010 and February 2012 from out-patient mental health care facilities in or near the Dutch cities of Eindhoven and Maastricht, and through local advertisements. Out-patients diagnosed with major depression (n = 101) receiving pharmacotherapy were randomized into: (i) ESM-I consisting of six weeks of ESM combined with weekly feedback regarding the individual's positive affective experiences, (ii) six weeks of ESM without feedback, or (iii) treatment as usual only. Alongside this randomised controlled trial, an economic evaluation was conducted consisting of a cost-effectiveness and a cost-utility analysis, using Hamilton Depression Rating Scale (HDRS) and quality adjusted life years (QALYs) as outcome, with willingness-to-pay threshold for a QALY set at €50,000 (based on Dutch guidelines for moderate severe to severe illnesses).ResultsThe economic evaluation showed that ESM-I is an optimal strategy only when willingness to pay is around €3000 per unit HDRS and around €40,500 per QALY. ESM-I was the least favourable treatment when willingness to pay was lower than €30,000 per QALY. However, at the €50,000 willingness-to-pay threshold, ESM-I was, with a 46% probability, the most favourable treatment (base-case analysis). Sensitivity analyses confirmed the robustness of these results.ConclusionsWe may tentatively conclude that ESM-I is a cost-effective add-on intervention to pharmacotherapy in outpatients with major depression.Trial registrationNetherlands Trial register, NTR1974 .
| S-EPMC5747107 | biostudies-literature
Project description:BACKGROUND:Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. OBJECTIVE:The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. METHODS:We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. RESULTS:Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). CONCLUSIONS:Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG)
| S-EPMC5945988 | biostudies-literature
Project description:Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors.The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors.Participants (n=352) were recruited from oncology clinics, a tumor registry, as well as through online mechanisms, such as Facebook and the Association of Cancer Online Resources (ACOR). Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment. Participants were randomly assigned to the Web-based program or a delayed-treatment control condition.In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls. There were no significant changes in fruit and vegetable consumption or other outcomes.The Web-based intervention impacted insomnia and exercise; however, a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Thus, the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited. Future work is discussed, with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit, such as in regard to social networking.Clinicaltrials.gov NCT00962494; http://www.clinicaltrials.gov/ct2/show/NCT00962494 (Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q).
| S-EPMC3961702 | biostudies-literature
Project description:BACKGROUND:Innovative interventions are needed to address the increasing mental health needs of university students. Given the demonstrated anxiolytic and antidepressant benefits of mindfulness training, we developed an 8-week, Web-based Mindfulness Virtual Community (MVC) intervention informed by cognitive behavioral therapy (CBT) constructs. OBJECTIVE:This study investigated the efficacy of the MVC intervention in reducing symptoms of depression, anxiety, and stress among undergraduate students in Toronto, Canada. The secondary outcomes included quality of life, life satisfaction, and mindfulness. METHODS:The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students' preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to video-based modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules. A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-face CBT; results for the latter group are presented elsewhere. Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting. The online surveys at baseline (T1), 4 weeks (T2), and 8 weeks (T3) included the Patient Health Questionnaire-9 item, Beck Anxiety Inventory, Perceived Stress Scale, Quality of Life Scale, Brief Multi-Dimensional Students Life Satisfaction Scale, and Five-Facet Mindfulness Questionnaire. Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible confounders (gender, age, birth country, paid work, unpaid work, physical activities, self-rated health, and mental health counseling access). RESULTS:Of the 113 students who provided T1 data, 28 were males and 85 were females with a mean age of 24.8 years. Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39) groups were similar in sociodemographic characteristics at T1. At T3 follow-up, per adjusted comparisons, there were statistically significant reductions in depression scores for F-MVC (score change -4.03; P<.001) and P-MVC (score change -4.82; P<.001) when compared with WLC. At T3, there was a statistically significant reduction in anxiety scores only for P-MVC (score change -7.35; P=.01) when compared with WLC. There was a statistically significant reduction in scores for perceived stress for both F-MVC (score change -5.32; P<.001) and P-MVC (score change -5.61; P=.005) compared with WLC. There were statistically significant changes at T3 for quality of life and mindfulness for F-MVC and P-MVC vs WLC but not for life satisfaction. CONCLUSIONS:Internet-based mindfulness CBT-based interventions, such as F-MVC and P-MVC, can result in significant reductions in symptoms of depression, anxiety, and stress in a student population. Future research with a larger sample from multiple universities would more precisely test generalizability. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.
| S-EPMC7055779 | biostudies-literature
Project description:BackgroundDepression prevention and early intervention have become a top priority in the Netherlands, but with considerable room for improvement. To address this, Web-based complaint-directed mini-interventions (CDMIs) were developed. These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, and have substantial economic impact.ObjectiveThe objective of this economic evaluation was to examine the added value of Web-based, unguided, self-help CDMIs compared with a wait-listed control group with unrestricted access to usual care from both a societal and a health care perspective.MethodsThis health economic evaluation was embedded in a randomized controlled trial. The study entailed 2 arms, in which 3 Web-based CDMIs were compared with a no-intervention waiting-list control group (which received the intervention after 3 months). We conducted measurements at baseline, and at 3 and 6 months. The primary outcome was the rate of responders to treatment on depressive symptoms as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). We estimated change in quality of life by calculating effect sizes (Cohen d) for individual pre- and posttreatment IDS-SR scores using a conversion factor to map a change in standardized effect size onto a corresponding change in utility. We calculated incremental cost-effectiveness ratios using bootstraps (5000 times) of seemingly unrelated regression equations and constructed cost-effectiveness acceptability curves for the costs per quality-adjusted life-year (QALY) gained.ResultsOf 329 study participants, we randomly assigned 165 to the CDMI group. At 3 months, the rate of responders to treatment was 13.9% (23/165) in the CDMI group and 7.3% (12/164) in the control group. At 3 months, participants in the CDMI group gained 0.15 QALYs compared with baseline, whereas participants in the control group gained 0.03 QALYs. Average total costs per patient at 3 months were €2094 for the CDMI group and €2230 for the control group (excluding baseline costs). Bootstrapped seemingly unrelated regression equations models resulted in a dominant incremental cost-effectiveness ratio (ie, lower costs and a higher rate of responders to treatment) for the CDMI group compared with the control group at 3 months, with the same result for the costs per QALY gained. Various sensitivity analyses attested to the robustness of the findings of the main analysis.ConclusionsBrief and low-threshold Web-based, unguided, self-help CDMIs have the potential to be a cost-effective addition to usual care for adults with mild to moderate depressive symptoms. The CDMIs improved health status, while reducing participant health care costs, and hence dominated the care-as-usual control condition. As intervention costs were relatively low, and the internet is readily available in the Western world, we believe CDMIs can be easily implemented on a large scale.Trial registrationNetherlands Trial Register NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).
| S-EPMC6231789 | biostudies-literature