Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial.

BACKGROUND: Depression 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. METHODS: This 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. RESULTS: We 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). CONCLUSIONS: We found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual. TRIAL REGISTRATION: NCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

Does symptom severity matter in stepped and collaborative care for depression?

BACKGROUND: We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments. METHODS: Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively. RESULTS: For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD. LIMITATIONS: There was a high proportion of missing values among severely depressed patients, especially in SCM. CONCLUSION: SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.

Effectiveness of Telephone-Administered Cognitive-Behavioral Psychotherapy for Depression With Versus Without Additional Letters: A Randomized Controlled Trial.

Background: Telephone-administered cognitive-behavioral psychotherapy (T-CBT) can effectively treat patients with depressive symptoms. Introduction: We investigated whether adding letters (via postal mail) to T-CBT reduces depressive symptoms and increases response and remission. Additionally, we assessed whether T-CBT reduced all patients' symptoms in the first depression-specific T-CBT sample in German healthcare. Materials and Methods: Primary care patients were randomized to T-CBT with versus without letters. All received 1 face-to-face and 8-12 telephone-administered sessions. An intention-to-treat sample was analyzed. Between-groups differences in symptom change and the total sample's symptom change were computed using linear mixed models with group as fixed effect, referring general practice as random effect and several covariates. Differences in response and remission were assessed using logistic regressions. Results: Fifty-nine patients were referred to T-CBT and randomized. Twenty-six patients actually participated in T-CBT with letters and 21 without letters. The groups did not differ significantly regarding symptom change (Patient Health Questionnaire [PHQ-9]) from baseline to end: T-CBT without letters showed 1.05 points greater reduction (95% confidence interval: -4.72 to 2.62; p = 0.56; Cohen's d = -0.12) (adjusted mean change). The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission. The total sample's PHQ-9 showed significant adjusted mean reduction from baseline to end of T-CBT and to 6-month follow-up. Discussion: Additional letters did not lead to greater symptom reduction. Overall results for the first German T-CBT intervention for depression appear promising but require further assessment using a control condition. Conclusions: Additional letters do not appear to enhance the effectiveness of T-CBT.

Treatment selection and treatment initialization in guideline-based stepped and collaborative care for depression.

In order to optimize patient allocation, guidelines recommend stepped and collaborative care models (SCM) including low-intensity treatments. The aim of this study is to investigate the implementation of guideline-adherent treatments in a SCM for depression in routine care. We analyzed care provider documentation data of n = 569 patients treated within a SCM. Rates of guideline-adherent treatment selections and initializations as well as accordance between selected and initialized treatment were evaluated for patients with mild, moderate and severe depression. Guideline-adherent treatment selection and initialization was highest for mild depression (91% resp. 85%). For moderate depression, guideline-adherent treatments were selected in 68% and applied in 54% of cases. Guideline adherence was lowest for severe depression (59% resp. 19%). In a multiple mixed logistic regression model a significant interaction between guideline adherence in treatment selection/initialization and severity degree was found. The differences between treatment selection and initialization were significant for moderate (OR: 1.8 [95% CI: 1.30 to 2.59; p = 0.0006]) and severe depression (OR: 6.9; [95% CI: 4.24 to 11.25; p < .0001] but not for mild depression (OR = 1.8, [95%-CI: 0.68 to 4.56; p = 0.2426]). Accordance between selected and initialized treatment was highest for mild and lowest for severe depression. We conclude that SCMs potentially improve care for mild depression and guideline adherence of treatment selections. Guideline adherence of treatment initialization and accordance between treatment selection and initialization varies with depression severity. Deficits in treating severe depression adequately may be more a problem of failed treatment initializations than of inadequate treatment selections.

Guideline-based stepped and collaborative care for patients with depression in a cluster-randomised trial.

Guidelines recommend stepped and collaborative care models (SCM) for depression. We aimed to evaluate the effectiveness of a complex guideline-based SCM for depressed patients. German primary care units were cluster-randomised into intervention (IG) or control group (CG) (3:1 ratio). Adult routine care patients with PHQ-9 ≥ 5 points could participate and received SCM in IG and treatment as usual (TAU) in CG. Primary outcome was change in PHQ-9 from baseline to 12 months (hypothesis: greater reduction in IG). A linear mixed model was calculated with group as fixed effect and practice as random effect, controlling for baseline PHQ-9 (intention-to-treat). 36 primary care units were randomised to IG and 13 to CG. 36 psychotherapists, 6 psychiatrists and 7 clinics participated in SCM. 737 patients were included (IG: n = 569 vs. CG: n = 168); data were available for 60% (IG) and 64% (CG) after 12 months. IG showed 2.4 points greater reduction [95% confidence interval (CI): -3.4 to -1.5, p < 0.001; Cohen's d = 0.45] (adjusted PHQ-9 mean change). Odds of response [odds ratio: 2.8; 95% CI: 1.6 to 4.7] and remission [odds ratio: 3.2; 95% CI: 1.58 to 6.26] were higher in IG. Guideline-based SCM can improve depression care.

Effectiveness and cost-effectiveness of telephone-based cognitive-behavioural therapy in primary care: study protocol of TIDe - telephone intervention for depression.

BACKGROUND: Despite the availability of evidence-based treatments for depression, a large proportion of patients remains untreated or adequate treatment is initiated with delay. This situation is particularly critical in primary care, where not only most individuals first seek help for their mental health problems, but also depressive disorders - particularly mild to moderate levels of severity - are highly prevalent given the high comorbidity of chronic somatic conditions and depression. Improving the access for evidence-based treatment, especially in primary care, is hence a priority challenge in the mental health care agenda. Telephone usage is widespread and has the potential of overcoming many barriers that individuals suffering from mental health problems are facing: Its implementation for treatment delivery presents an option for optimisation of treatment pathways and outcomes. METHODS/DESIGN: This paper details the study protocol for a randomised controlled trial (RCT) evaluating the effectiveness of a telephone-administered short-term cognitive-behavioural therapy (T-CBT) for depression as compared to treatment as usual (TAU) in the Swiss primary care setting. The study aims at randomising a total of 216 mildly to moderately depressed patients, which are either identified by their General Practitioners (GPs) or who self-refer to the study programme in consultation with their GP. The trial will examine whether telephone-delivered, manualised treatment leads to clinically significant reduction in depression at follow-up. It will further investigate the cost-effectiveness and acceptability of the intervention in the primary care setting. DISCUSSION: Conducting a low-intensity treatment on the telephone allows for greater flexibility for both patient and therapist, can grant more anonymity and can thus lead to less hesitation in the patient about whether to attempt treatment or not. In order to benefit from this approach, large-scale studies need to prove superior effectiveness and cost-effectiveness of telephone-delivered therapy over routine care for patients with mild to moderate depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02667366 . Registered on 3 December 2015.

[psychenet - The Hamburg Network for Mental Health: Evaluation of the Health Network Depression from the Perspective of Participating General Practitioners, Psychotherapists and Psychiatrists]. / psychenet - Hamburger Netz psychische Gesundheit: Evaluation des Gesundheitsnetzes Depression aus Sicht der teilnehmenden Hausärzte, Psychotherapeuten und Psychiater.

OBJECTIVE: Evaluation of satisfaction and acceptance of a stepped care model in the Health Network Depression from the perspective of general practitioners, psychotherapists and psychiatrists. METHODS: Cross-sectional questionnaire study with n = 61 care providers. RESULTS: All elements of the stepped care model, e. g. screening, diagnostic, and monitoring checklists, guidelines, low-intensity treatment options and IT-tools were utilized by over 75 % of partners and obtained largely positive ratings. CONCLUSION: This positive evaluation provides a basis for further participative development and transfer into health care.

[Collaborative and stepped care for depression: Development of a model project within the Hamburg Network for Mental Health (psychenet.de)]. / Collaborative und Stepped Care bei depressiven Erkrankungen : Entwicklung eines Modellprojektes im Hamburger Netz psychische Gesundheit (psychenet.de).

BACKGROUND: Depression is one of the most widespread mental disorders in Germany and causes a great suffering and involves high costs. Guidelines recommend stepped and interdisciplinary collaborative care models for the treatment of depression. OBJECTIVES: Stepped and collaborative care models are described regarding their efficacy and cost-effectiveness. A current model project within the Hamburg Network for Mental Health exemplifies how guideline-based stepped diagnostics and treatment incorporating innovative low-intensity interventions are implemented by a large network of health care professionals and clinics. MATERIALS AND METHODS: An accompanying evaluation using a cluster randomized controlled design assesses depressive symptom reduction and cost-effectiveness for patients treated within "Health Network Depression" ("Gesundheitsnetz Depression", a subproject of psychenet.de) compared with patients treated in routine care. RESULTS: Over 90 partners from inpatient and outpatient treatment have been successfully involved in recruiting over 600 patients within the stepped care model. Communication in the network was greatly facilitated by the use of an innovative online tool for the supply and reservation of treatment capacities. The participating professionals profit from the improved infrastructure and the implementation of advanced training and quality circle work. CONCLUSIONS: New treatment models can greatly improve the treatment of depression owing to their explicit reference to guidelines, the establishment of algorithms for diagnostics and treatment, the integration of practices and clinics, in addition to the implementation of low-intensity treatment alternatives. These models could promote the development of a disease management program for depression.

Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care.

BACKGROUND: Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease. The lack of integration between different care providers impedes guideline-based treatment. This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs. To face these challenges, the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting, including low-intensity treatments using innovative technologies. METHODS/DESIGN: The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year. A cluster randomization at the level of participating primary care units divides the general practitioners into two groups. In the intervention group patients (n = 660) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners, psychotherapists, psychiatrists and inpatient care facilities, whereas patients in the control condition (n = 200) receive routine care. The main research question concerns the effectiveness of the stepped-care model from baseline to t3 (12 months). Primary outcome is the change in depressive symptoms measured by the PHQ-9; secondary outcomes include response, remission and relapse, functional quality of life (SF-12 and EQ-5D-3 L), other clinical and psychosocial variables, direct and indirect costs, and the incremental cost-effectiveness ratio. Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed. DISCUSSION: This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression; it elaborates innovative and evidence-based treatment elements, follows a stratified approach and is implemented in routine care as opposed to standardized conditions. In case of positive results, its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, number NCT01731717 (date of registration: 24 June 2013).