Web-based intervention for depressive symptoms in adults with types 1 and 2 diabetes mellitus:A health economic evaluation

Background: Web-based interventions are effective in reducing depression. However, the evidence for the cost-effectiveness of these interventions is scarce. Aims: The aim is to assess the cost-effectiveness of a web-based intervention (GET.ON M.E.D.) for individuals with diabetes and comorbid depression compared with an active control group receiving web-based psychoeducation. Method: We conducted a cost-effectiveness analysis with treatment response as the outcome and a cost-utility analysis with qualityadjusted life-years (QALYs) alongside a randomised controlled trial with 260 participants. Results: At a willingness-to-pay ceiling of €5000 for a treatment response, the intervention has a 97% probability of being regarded as costeffective compared with the active control group. If society is willing to pay €14 000 for an additional QALY, the intervention has a 51% probability of being cost-effective. Conclusions: This web-based intervention for individuals with diabetes and comorbid depression demonstrated a high probability of being cost-effective compared with an active control group

Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial

Background: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. Methods. The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α =.05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. Discussion. The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed. Trial registration. German Register of Clinical Studies (DRKS): DRKS00004749. © 2013 Heber et al.; licensee BioMed Central Ltd

Do Nonsuicidal Severely Depressed Individuals with Diabetes Profit from Internet-Based Guided Self-Help? Secondary Analyses of a Pragmatic Randomized Trial

Introduction. Diabetes mellitus type 1 and type 2 are linked to higher prevalence and occurrences of depression. Internet-based depression- and diabetes-specific cognitive behavioral therapies (CBT) can be effective in reducing depressive symptom severity and diabetes-related emotional distress. The aim of the study was to test whether disease-specific severity indicators moderate the treatment outcome in a 6-week minimally guided web-based self-help intervention on depression and diabetes (GET.ON Mood Enhancer Diabetes (GET.ON M.E.D.)) and to determine its effectiveness in a nonsuicidal severely depressed subgroup. Methods. Randomized controlled trial- (RCT-) based data (N=253) comparing GET.ON M.E.D. to an online psychoeducation control group was used to test disease-specific severity indicators as predictors/moderators of a treatment outcome. Changes in depressive symptom severity and treatment response were examined in a nonsuicidal severely depressed subgroup (CES−D>40; N=40). Results. Major depressive disorder diagnosis at the baseline (pprf6=0.01), higher levels of depression (Beck Depression Inventory II; pprpo=0.00; pprf6=0.00), and lower HbA1c (pprpo=0.04) predicted changes in depressive symptoms. No severity indicator moderated the treatment outcome. Severely depressed participants in the intervention group showed a significantly greater reduction in depressive symptom severity (dprpo=2.17, 95% Confidence Interval (CI): 1.39-2.96) than the control condition (dprpo=0.92; 95% CI: 0.001-1.83), with a between-group effect size of dprpo=1.05 (95% CI: 0.11-1.98). Treatment response was seen in significantly more participants in the intervention (4/20; 20%) compared to the control group (0/20, 0%; χ2 2N=40=4.44; p<0.02). At the 6-month follow-up, effects were maintained for depressive symptom reduction (dpr6f=0.71; 95% CI: 0.19-1.61) but not treatment response. Conclusion. Disease-specific severity indicators were not related to a differential effectiveness of guided self-help for depression and diabetes. Clinical meaningful effects were observed in nonsuicidal severely depressed individuals, who do not need to be excluded from web-based guided self-help. However, participants should be closely monitored and referred to other treatment modalities in case of nonresponse

Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain: protocol of a multi-centre randomised controlled trial

INTRODUCTION: Depression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare. METHODS AND ANALYSIS: In this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months. ETHICS AND DISSEMINATION: All procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences. TRIAL REGISTRATION NUMBER: DRKS00009272; Pre-results