Long-term Impacts and Benefit-Cost Analysis of the Communities That Care Prevention System at Age 23, 12 Years After Baseline.

This study estimated sustained impacts and long-term benefits and costs of the Communities That Care (CTC) prevention system, implemented and evaluated in a longitudinal cluster-randomized trial involving 24 communities in seven states. Analyses utilized reports from a longitudinal panel of 4407 participants, followed since the study's baseline in grade 5, with most recent follow-up 12 years later at age 23. Impacts on lifetime abstinence from primary outcomes of substance use and antisocial behavior were estimated using generalized linear mixed Poisson regression analysis, adjusted for individual and community-level covariates. Possible cascading effects on 4-year college completion, major depressive disorder, and generalized anxiety disorder through age 23 were evaluated as secondary outcomes. CTC had a statistically significant global effect on primary outcomes and also on combined primary and secondary outcomes. Among primary outcomes, point estimates suggested absolute improvements in lifetime abstinence of 3.5 to 6.1% in the intervention arm and relative improvements of 13 to 55%; 95% confidence intervals revealed some uncertainty in estimates. Among secondary outcomes, 4-year college completion was 1.9% greater among young adults from intervention communities, a 20% relative improvement. Mental health outcomes were approximately the same across trial arms. Although CTC had small sustained effects through age 23, benefit-cost analyses indicated CTC was reliably cost beneficial, with a net present value of $7152 (95% credible interval: $1253 to $15,268) per participant from primary impacts and $17,919 ($306 to $39,186) when secondary impacts were also included. It remained cost beneficial even when impacts were adjusted downward due to the involvement of CTC's developer in the trial. Findings suggest that broader dissemination of CTC could improve public health and individual lives in the long term and generate positive net benefits to society.

Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.

BACKGROUND: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions. METHODS: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1. RESULTS: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (ß=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low. LIMITATIONS: Results are limited to green professions and representativeness might be restricted by self-selection of participants. CONCLUSION: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.

Youth Depression in School Settings: Assessment, Interventions, and Prevention.

In this article, the authors make a compelling case that all clinicians who treat youth with depressive disorders should embrace strategies to engage with school staff to best serve their patients in the classroom. Because these disorders have a high incidence in the school population (13% of US teens experienced at least 1 major depressive episode in 2016), this can affect learning, social interactions, and classroom engagement. Several approaches are highlighted for assessment of depressive symptoms, intervention and treatment in school settings, and prevention strategies, including depression education curricula and programs promoting subjective well-being, such as positive psychology and mindfulness.

Estimation of a Relative Risk Effect Size when Using Continuous Outcomes Data: An Application of Methods in the Prevention of Major Depression and Eating Disorders.

INTRODUCTION: The raw mean difference (RMD) and standardized mean difference (SMD) are continuous effect size measures that are not readily usable in decision-analytic models of health care interventions. This study compared the predictive performance of 3 methods by which continuous outcomes data collected using psychiatric rating scales can be used to calculate a relative risk (RR) effect size. METHODS: Three methods to calculate RR effect sizes from continuous outcomes data are described: the RMD, SMD, and Cochrane conversion methods. Each conversion method was validated using data from randomized controlled trials (RCTs) examining the efficacy of interventions for the prevention of depression in youth (aged ≤17 years) and adults (aged ≥18 years) and the prevention of eating disorders in young women (aged ≤21 years). Validation analyses compared predicted RR effect sizes to actual RR effect sizes using scatterplots, correlation coefficients ( r), and simple linear regression. An applied analysis was also conducted to examine the impact of using each conversion method in a cost-effectiveness model. RESULTS: The predictive performances of the RMD and Cochrane conversion methods were strong relative to the SMD conversion method when analyzing RCTs involving depression in adults (RMD: r = 0.89-0.90; Cochrane: r = 0.73; SMD: r = 0.41-0.67) and eating disorders in young women (RMD: r = 0.89; Cochrane: r = 0.96). Moderate predictive performances were observed across the 3 methods when analyzing RCTs involving depression in youth (RMD: r = 0.50; Cochrane: r = 0.47; SMD: r = 0.46-0.46). Negligible differences were observed between the 3 methods when applied to a cost-effectiveness model. CONCLUSION: The RMD and Cochrane conversion methods are both valid methods for predicting RR effect sizes from continuous outcomes data. However, further validation and refinement are required before being applied more broadly.

Database Analysis of Depression and Anxiety in a Community Sample-Response to a Micronutrient Intervention.

BACKGROUND: Depression and anxiety are common mental health concerns worldwide. Broad-spectrum multi-vitamin/mineral approaches have been found to alleviate a number of psychiatric symptoms. We investigated the effects of a nutrient intervention program, which includes optimizing vitamin D levels, on depression and anxiety outcomes from community-based program. METHODS: We evaluated self-reported health measures of depression and anxiety collected as part of a community-based program focused on optimizing overall health through nutritional supplementation, education and lifestyle advice. RESULTS: Data were collected from 16,020 participants, with measures including European Quality of Life Five Dimensions (EQ-5D) and Targeted Symptoms List (TSL) providing self-reported depression and anxiety. More than 56% of participants were identified as having elevated levels of depression and anxiety at baseline as reported on the EQ-5D. After one year in the program, 49.2% (n = 7878) of participants who reported any level of depression or anxiety at baseline reported improvement at follow-up. Of those who reported severe/extreme depression at baseline (n = 829), 97.2% reported improvement after one year. Regression analyses revealed a significant association of improvement in depression and anxiety with higher vitamin D status (>100 nmol/L) and more strenuous physical activity. CONCLUSION: Overall, people from the general population who suffer from mood and anxiety problems may benefit from improved nutritional status achieved with nutritional supplements.

Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.

BACKGROUND: Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. METHODS: This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. DISCUSSION: This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. TRIAL REGISTRATION: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960 . Registered 12 August 2015.

The population cost-effectiveness of delivering universal and indicated school-based interventions to prevent the onset of major depression among youth in Australia.

AIMS: School-based psychological interventions encompass: universal interventions targeting youth in the general population; and indicated interventions targeting youth with subthreshold depression. This study aimed to: (1) examine the population cost-effectiveness of delivering universal and indicated prevention interventions to youth in the population aged 11-17 years via primary and secondary schools in Australia; and (2) compare the comparative cost-effectiveness of delivering these interventions using face-to-face and internet-based delivery mechanisms. METHODS: We reviewed literature on the prevention of depression to identify all interventions targeting youth that would be suitable for implementation in Australia and had evidence of efficacy to support analysis. From this, we found evidence of effectiveness for the following intervention types: universal prevention involving group-based psychological interventions delivered to all participating school students; and indicated prevention involving group-based psychological interventions delivered to students with subthreshold depression. We constructed a Markov model to assess the cost-effectiveness of delivering universal and indicated interventions in the population relative to a 'no intervention' comparator over a 10-year time horizon. A disease model was used to simulate epidemiological transitions between three health states (i.e., healthy, diseased and dead). Intervention effect sizes were based on meta-analyses of randomised control trial data identified in the aforementioned review; while health benefits were measured as Disability-adjusted Life Years (DALYs) averted attributable to reductions in depression incidence. Net costs of delivering interventions were calculated using relevant Australian data. Uncertainty and sensitivity analyses were conducted to test model assumptions. Incremental cost-effectiveness ratios (ICERs) were measured in 2013 Australian dollars per DALY averted; with costs and benefits discounted at 3%. RESULTS: Universal and indicated psychological interventions delivered through face-to-face modalities had ICERs below a threshold of $50 000 per DALY averted. That is, $7350 per DALY averted (95% uncertainty interval (UI): dominates - 23 070) for universal prevention, and $19 550 per DALY averted (95% UI: 3081-56 713) for indicated prevention. Baseline ICERs were generally robust to changes in model assumptions. We conducted a sensitivity analysis which found that internet-delivered prevention interventions were highly cost-effective when assuming intervention effect sizes of 100 and 50% relative to effect sizes observed for face-to-face delivered interventions. These results should, however, be interpreted with caution due to the paucity of data. CONCLUSIONS: School-based psychological interventions appear to be cost-effective. However, realising efficiency gains in the population is ultimately dependent on ensuring successful system-level implementation.

Development, acceptability and efficacy of a standardized healthy lifestyle intervention in recurrent depression.

BACKGROUND: Research evidence on the effects of integrated multifaceted lifestyle interventions for depression is scanty. The aim of the present study is to report on the development, acceptability and efficacy of a standardized healthy lifestyle intervention, including exercise, eating habits, sleep hygiene and smoking cessation in preventing relapses. METHODS: One hundred-sixty outpatients with recurrent unipolar depression or bipolar disorder were recruited after achieving full remission or recovery from the most recent depressive episode. Patients were randomized to 3-months of usual care or to an intervention aimed at promoting a healthy lifestyle (HLI), as an augmentation of pharmacological maintenance treatment. Usual care consisted of clinical management visits. At the end of the intervention, follow-up visits were scheduled at 3,6,9 and 12 months. RESULTS: During the intervention phase, 1 relapse occurred in the HLI group and 4 in the control group. Over the 12 months of follow-up, relapses were 5 in the HLI group and 16 in control group. Using an intent-to-treat approach, the overall percentage of relapses was 6/81 (7.4%) in the HLI group vs. 20/79 (25.3%) in the control group.. In a Kaplan-Meier survival analysis the risk of relapse was significantly lower in patients receiving the HLI intervention (log-rank test, p=0.003) over the 60 weeks of observation. The majority of patients assigned to HLI adhered to the program, and were highly motivated throughout the intervention. LIMITATIONS: The retention rate was low because patients were recruited during the maintenance phase and the 1-year follow-up was relatively short to detect a long-term effect of HLI. CONCLUSIONS: The HLI program proved to be efficacious in preventing relapses. Given the absence of contraindications and its cost-effectiveness in routine practice, the use of HLI should be encouraged to promote the well-being of patients with recurrent depression.

"Nudges" to Prevent Behavioral Risk Factors Associated With Major Depressive Disorder.

Major depressive disorder-colloquially called "depression"-is a primary global cause of disability. Current preventive interventions, such as problem-solving therapy, are effective but also expensive. "Nudges" are easy and cheap interventions for altering behavior. We have explored how nudging can reduce three behavioral risk factors of depression: low levels of physical activity, inappropriate coping mechanisms, and inadequate maintenance of social ties. These nudges use cognitive biases associated with these behavioral risks, such as valuing the present more than the future, following the herd or the norm, making different choices in light of equivalent conditions, and deciding on the basis of salience or attachment to status quo.

The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study).

BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial. OBJECTIVES: To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action. DESIGN: Single-blind, parallel, individual randomised controlled trial. SETTING: UK general practices. PARTICIPANTS: Adult patients with a diagnosis of recurrent depression and who were taking m-ADM. INTERVENTIONS: Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action. MAIN OUTCOMES MEASURES: The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities. RESULTS: In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation. CONCLUSIONS: There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26666654. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full in Health Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.

Preventive Cognitive Therapy versus Treatment as Usual in preventing recurrence of depression: protocol of a multi-centered randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Therefore, part of the efforts to reduce the disabling effects of depression should focus on preventing recurrence, especially in patients at high risk of recurrence. The best established effective psychological intervention is cognitive therapy, with indications for prophylactic effects after remission. METHODS/DESIGN: In this randomized controlled trial (cost-) effectiveness of Preventive Cognitive Therapy (PCT) after response to Acute Cognitive Therapy (A-CT) will be evaluated in comparison with Treatment As Usual (TAU). Remitted patients that responded to A-CT treatment with at least two previous depressive episodes will be recruited. Randomization will be stratified for number of previous episodes. Follow-ups are at 3, 6, 12 and 15 months. The primary outcome measure will be the time to relapse or recurrence of depression meeting DSM-IV criteria for a major depressive episode on the Structured Clinical Interview for DSM-VI Axis I Disorders (SCID-I). Costs will be measured from a societal perspective. DISCUSSION: This study is the first to examine the addition of PCT to TAU, compared to TAU alone in patients that recovered from depressive disorder with A-CT. Alongside this effect study a cost effectiveness analysis will be conducted. Furthermore, the study explores potential moderators to examine what works for whom. TRIAL REGISTRATION: Netherlands Trial Register (NTR): 2599 , date of registration: 11-11-2010.

Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.

BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. METHODS: In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. FINDINGS: Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67-1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. INTERPRETATION: We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

Place and health in diabetes: the neighbourhood environment and risk of depression in adults with type 2 diabetes.

BACKGROUND: Depression is a common co-illness in people with diabetes. Evidence suggests that the neighbourhood environment impacts the risk of depression, but few studies have investigated this effect in those with diabetes. We examined the effect of a range of neighbourhood characteristics on depression in people with Type 2 diabetes. METHODS: This cohort study used five waves of data from 1298 participants with Type 2 diabetes from the Diabetes Health Study (2008-2013). We assessed depression using the Patient Health Questionnaire. We measured neighbourhood deprivation using census data; density of services using geospatial data; level of greenness using satellite imagery; and perceived neighbourhood characteristics using survey data. The effect of neighbourhood factors on risk of depression was estimated using survival analysis, adjusting for sociodemographic variables. We tested effect modification by age, sex and socio-economic characteristics using interaction terms. RESULTS: More physical activity facilities, cultural services and a greater level of greenness in the neighbourhood were associated with a lower risk of depression in our sample, even after adjusting for confounders. Material deprivation was associated with increased risk of depression, particularly in participants who were older or retired. CONCLUSIONS: Characteristics of neighbourhoods were associated with the risk of depression in people with Type 2 diabetes and there were vulnerable subgroups within this association. Clinicians are encouraged to consider the neighbourhood environment of their patients when assessing the risk of depression. Future intervention research is need for health policy recommendations.

Prevention of adolescent depression in the Spanish-speaking world.

This paper aims at presenting programs targeted at the prevention of adolescent depression applied with Spanish-speaking populations that have been developed in Spanish-speaking countries and are mostly published in Spanish. These programs have been developed under different cultural contexts in Spain and Latin-America. The main goal of this paper is to make the studies and movements of the Spanish-speaking literature in this field accessible to the non-Spanish-speaking part of the research community. Therefore, after an introduction referring to possible cultural differences regarding depression in general and epidemiological basics, several programs are introduced. In total 11 programs will be shortly presented and discussed. After revising the programs it can be concluded that in the Spanish-speaking world many programs have been developed and conducted following current state of the art-approaches for adolescent depression prevention. Further research is needed especially targeting possible cultural and contextual aspects of prevention measures and their efficacy and efficiency.

Evaluating the efficacy and cost-effectiveness of web-based indicated prevention of major depression: design of a randomised controlled trial.

BACKGROUND: Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. Web-based interventions have shown to be effective in reducing depressive symptom severity. However, it is not known whether web-based interventions may also be effective in preventing the onset of MDD. The aim of this study is to evaluate the (cost-) effectiveness of an indicated web-based guided self-help intervention (GET.ON Mood Enhancer Prevention) on the onset of MDD. METHODS/DESIGN: A randomised controlled trial (RCT) will be conducted to compare the (cost-) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression. Adults with subthreshold depression (N = 406) will be recruited from the general population and randomised to one of the two conditions. The primary outcome is time to onset of MDD within a 12-months follow-up period. MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV (SCID). Time to onset of MDD will be assessed using life charts. Secondary outcomes include changes on various indicators of depressive symptom severity, anxiety and quality of life from baseline to post-treatment, to a 6-month and a 12-month follow up. Additionally, an economic evaluation using a societal perspective will be conducted to examine the intervention's cost-effectiveness. DISCUSSION: This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression. If shown to be effective, the intervention will contribute to reducing the disease burden due to MDD in the general population. TRIAL REGISTRATION: German Clinical Trial Registration DRKS00004709.

Modelling the cost-effectiveness of preventing major depression in general practice patients.

BACKGROUND: The prevention of depression is a key public health policy priority. PredictD is the first risk algorithm for the prediction of the onset of major depression. Our aim in this study was to model the cost-effectiveness of PredictD in depression prevention in general practice (GP). METHOD: A decision analytical model was developed to determine the cost-effectiveness of two approaches, each of which was compared to treatment as usual (TAU) over 12 months: (1) the PredictD risk algorithm plus a low-intensity depression prevention programme; and (2) a universal prevention programme in which there was no initial identification of those at risk. The model simulates the incidence of depression and disease progression over 12 months and calculates the net monetary benefit (NMB) from the National Health Service (NHS) perspective. RESULTS: Providing patients with PredictD and a depression prevention programme prevented 15 (17%) cases of depression in a cohort of 1000 patients over 12 months and had the highest probability of being the optimal choice at a willingness to pay (WTP) of £20,000 for a quality-adjusted life year (QALY). Universal prevention was strongly dominated by PredictD plus a depression prevention programme in that universal prevention resulted in less QALYs than PredictD plus prevention for a greater cost. CONCLUSIONS: Using PredictD to identify primary-care patients at high risk of depression and providing them with a low-intensity prevention programme is potentially cost-effective at a WTP of £20,000 per QALY.

Cost-effectiveness of a stepped care programme to prevent depression and anxiety in residents in homes for the older people: a randomised controlled trial.

BACKGROUND: Depression and anxiety are common in residents of elderly homes. Both disorders have negative effects on functioning, well-being and health-care utilisation. Besides treatment, prevention can be an option to reduce the burden of mental disorders. The objective of this study was to evaluate the cost-effectiveness of a stepped care programme to prevent the onset of depression and anxiety disorders in residents of elderly homes compared with usual care from a societal perspective. METHODS: Outcomes were incidence of depression and/or anxiety, severity of depressive and anxiety symptoms and quality-adjusted life years. Health-care utilisation was measured during interviews. Multiple imputation was used to impute missing cost and effect data. Uncertainty around cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and acceptability curves were created. RESULTS: The incidence of depression and anxiety combined in the intervention group was not reduced in comparison with the usual care group. There was also no effect on the other outcomes. Mean total costs in the intervention group were €838 higher than in the usual care group, but this difference was not statistically significant (95% confidence interval, -593 to 2420). Cost-effectiveness planes showed that there was considerable uncertainty. Cost-effectiveness acceptability curves showed that the maximum probability of the intervention being cost-effective in comparison with usual care was 0.46 for reducing the incidence of depression and anxiety combined. CONCLUSION: A stepped care programme to prevent depression and anxiety in older people living in elderly homes was not considered cost-effective in comparison with usual care.

Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study).

BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS/DESIGN: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01151982.