Dataset Information

Cost-effectiveness of a stepped care program to prevent depression among primary care patients with diabetes mellitus type 2 and/or coronary heart disease and subthreshold depression in comparison with usual care.

ABSTRACT:

Background

Patients with diabetes mellitus type 2 (DM2) and/or coronary heart disease (CHD) are at high risk to develop major depression. Preventing incident major depression may be an important tool in reducing the personal and societal burden of depression. The aim of the current study was to assess the cost-effectiveness of a stepped care program to prevent major depression (Step-Dep) in diabetes mellitus type 2 and/or coronary heart disease patients with subthreshold depression in comparison with usual care.

Methods

An economic evaluation with 12 months follow-up was conducted alongside a pragmatic cluster-randomized controlled trial from a societal perspective. Participants received care as usual (n = 140) or Step-Dep (n = 96) which consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to a general practitioner. Primary outcomes were quality-adjusted life years (QALYs) and cumulative incidence of major depression. Costs were measured every 3 months. Missing data was imputed using multiple imputation. Uncertainty around cost-effectiveness outcomes was estimated using bootstrapping and presented in cost-effectiveness planes and acceptability curves.

Results

There were no significant differences in QALYs or depression incidence between treatment groups. Secondary care costs (mean difference €1644, 95% CI €344; €3370) and informal care costs (mean difference €1930, 95% CI €528; €4089) were significantly higher in the Step-Dep group than in the usual care group. The difference in total societal costs (€1001, 95% CI €-3975; €6409) was not statistically significant. The probability of the Step-Dep intervention being cost-effective was low, with a maximum of 0.41 at a ceiling ratio of €30,000 per QALY gained and 0.32 at a ceiling ratio of €0 per prevented case of major depression.

Conclusions

The Step-Dep intervention is not cost-effective compared to usual care in a population of patients with DM2/CHD and subthreshold depression. Therefore, widespread implementation cannot be recommended.

Trial registration

The trial was registered in the Netherlands Trial Register ( NTR3715 ).

SUBMITTER: van Dijk SEM

PROVIDER: S-EPMC8361858 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCo-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms.Methods/designAn economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months.DiscussionThe intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression, with subsequent beneficial effects on quality of life, clinical outcomes and health care costs. When proven cost-effective, the program provides a viable treatment option in the Dutch primary care system.Trial registrationDutch Trial Register NTR3715.

Project description:PurposeGiven the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD.MethodsA cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months.ResultsOf 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups.ConclusionsThis study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression.

Project description:BackgroundDepression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline "Unipolar Depression" has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression.MethodsThis prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by 'multiple imputation using chained equations' based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered.ResultsWe found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [-€259;€10,290) and effects (+ 0.008 QALY; 95%-CI: [- 0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained).ConclusionsWe found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual.Trial registrationNCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

Project description:IntroductionMajor depressive disorders (MDD), diabetes mellitus type 2 (DM2) and coronary heart disease (CHD) are leading contributors to the global burden of disease and often co-occur.ObjectivesTo evaluate the 2-year effectiveness of a stepped-care intervention to prevent MDD compared with usual care and to develop a prediction model for incident depression in patients with DM2 and/or CHD with subthreshold depression.MethodsData of 236 Dutch primary care patients with DM2/CHD with subthreshold depression (Patient Health Questionnaire 9 (PHQ-9) score ?6, no current MDD according to the Mini International Neuropsychiatric Interview (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria)) who participated in the Step-Dep trial were used. A PHQ-9 score of ?10 at minimally one measurement during follow-up (at 3, 6, 9, 12 and 24 months) was used to determine the cumulative incidence of MDD. Potential demographic and psychological predictors were measured at baseline via web-based self-reported questionnaires and evaluated using a multivariable logistic regression model. Model performance was assessed with the Hosmer-Lemeshow test, Nagelkerke's R2 explained variance and area under the receiver operating characteristic curve (AUC). Bootstrapping techniques were used to internally validate our model.Results192 patients (81%) were available at 2-year follow-up. The cumulative incidence of MDD was 97/192 (51%). There was no statistically significant overall treatment effect over 24 months of the intervention (OR 1.37; 95%?CI 0.52 to 3.55). Baseline levels of anxiety, depression, the presence of >3?chronic diseases and stressful life events predicted the incidence of MDD (AUC 0.80, IQR 0.79-0.80; Nagelkerke's R2 0.34, IQR 0.33-0.36).ConclusionA model with 4 factors predicted depression incidence during 2-year follow-up in patients with DM2/CHD accurately, based on the AUC. The Step-Dep intervention did not influence the incidence of MDD. Future depression prevention programmes should target patients with these 4 predictors present, and aim to reduce both anxiety and depressive symptoms.Trial registration numberNTR3715.

Project description:ImportancePsychiatric interventions offered after natural disasters commonly address subsyndromal symptom presentations, but often remain insufficient to reduce the burden of chronic posttraumatic stress disorder (PTSD).ObjectiveTo simulate a comparison of a stepped care case-finding intervention (stepped care [SC]) vs a moderate-strength single-level intervention (usual care [UC]) on treatment effectiveness and incremental cost-effectiveness in the 2 years after a natural disaster.Design, setting, and participantsThis study, which simulated treatment scenarios that start 4 weeks after landfall of Hurricane Sandy on October 29, 2012, and ending 2 years later, created a model of 2 642 713 simulated agents living in the areas of New York City affected by Hurricane Sandy.InterventionsUnder SC, cases were referred to cognitive behavioral therapy, an evidence-based therapy that aims to improve symptoms through problem solving and by changing thoughts and behaviors; noncases were referred to Skills for Psychological Recovery, an evidence-informed therapy that aims to reduce distress and improve coping and functioning. Under UC, all patients were referred only to Skills for Psychological Recovery.Main outcomes and measuresThe reach of SC compared with UC for 2 years, the 2-year reduction in prevalence of PTSD among the full population, the 2-year reduction in the proportion of PTSD cases among initial cases, and 10-year incremental cost-effectiveness.ResultsThis population of 2 642 713 simulated agents was initialized with a PTSD prevalence of 4.38% (115 751 cases) and distributions of sex (52.6% female and 47.4% male) and age (33.9% aged 18-34 years, 49.0% aged 35-64 years, and 17.1% aged ≥65 years) that were comparable with population estimates in the areas of New York City affected by Hurricane Sandy. Stepped care was associated with greater reach and was superior to UC in reducing the prevalence of PTSD in the full population: absolute benefit was clear at 6 months (risk difference [RD], -0.004; 95% CI, -0.004 to -0.004), improving through 1.25 years (RD, -0.015; 95% CI, -0.015 to -0.014). Relative benefits of SC were clear at 6 months (risk ratio, 0.905; 95% CI, 0.898-0.913), with continued gains through 1.75 years (risk ratio, 0.615; 95% CI, 0.609-0.662). The absolute benefit of SC among cases was much stronger, emerging at 3 months (RD, -0.006; 95% CI, -0.007 to -0.005) and increasing through 1.5 years (RD, -0.338; 95% CI, -0.342 to -0.335). Relative benefits of SC among cases were equivalent to those observed in the full population. The incremental cost-effectiveness of SC compared with UC was $3428.71 to $6857.68 per disability-adjusted life year avoided, and $0.80 to $1.61 per PTSD-free day.Conclusions and relevanceThe results of this simulation study suggest that SC for individuals with PTSD in the aftermath of a natural disaster is associated with greater reach than UC, more effectiveness than UC, and is well within the range of acceptability for cost-effectiveness. Results should be considered in light of limitations inherent to agent-based models.

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Project description:ObjectiveTo provide an estimate of the effect of interventions on comorbid depressive disorder (MDD) or subthreshold depression in type 1 and type 2 diabetes.MethodsSystematic review and meta-analysis. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomized controlled trials evaluating the outcome of depression treatments in diabetes and comorbid MDD or subthreshold symptoms published before August 2019 compared to care as usual (CAU), placebo, waiting list (WL), or active comparator treatment as in a comparative effectiveness trial (CET). Primary outcomes were depressive symptom severity and glycemic control. Cohen's d is reported.ResultsForty-three randomized controlled trials (RCTs) were selected, and 32 RCTs comprising 3,543 patients were included in the meta-analysis. Our meta-analysis showed that, compared to CAU, placebo or WL, all interventions showed a significant effect on combined outcome 0,485 (95% CI 0.360; 0.609). All interventions showed a significant effect on depression. Pharmacological treatment, group therapy, psychotherapy, and collaborative care had a significant effect on glycemic control. High baseline depression score was associated with a greater reduction in HbA1 c and depressive outcome. High baseline HbA1 c was associated with a greater reduction in HbA1 c.ConclusionAll treatments are effective for comorbid depression in type 1 diabetes and type 2 diabetes. Over the last decade, new interventions with large effect sizes have been introduced, such as group-based therapy, online treatment, and exercise. Although all interventions were effective for depression, not all treatments were effective for glycemic control. Effective interventions in comorbid depressive disorder may not be as effective in comorbid subthreshold depression. Baseline depression and HbA1 c scores modify the treatment effect. Based on the findings, we provide guidance for treatment depending on patient profile and desired outcome, and discuss possible avenues for further research.