Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Buntrock C

PROVIDER: S-EPMC3914724 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Buntrock Claudia C Ebert David D DD Lehr Dirk D Cuijpers Pim P Riper Heleen H Smit Filip F Berking Matthias M

BMC psychiatry 20140131

<h4>Background</h4>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.<h4>M ...[more]

PMID: 24485283

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Project description:BackgroundTo reduce the large public health burden of the high prevalence of depression, preventive interventions targeted at people at risk are essential and can be cost-effective. Web-based interventions are able to provide this care, but there is no agreement on how to best develop these applications and often the technology is seen as a given. This seems to be one of the main reasons that web-based interventions do not reach their full potential. The current study describes the development of a web-based intervention for the indicated prevention of depression, employing the CeHRes (Center for eHealth Research and Disease Management) roadmap. The goals are to create a user-friendly application which fits the values of the stakeholders and to evaluate the process of development.MethodsThe employed methods are a literature scan and discussion in the contextual inquiry; interviews, rapid prototyping and a requirement session in the value specification stage; and user-based usability evaluation, expert-based usability inspection and a requirement session in the design stage.ResultsThe contextual inquiry indicated that there is a need for easily accessible interventions for the indicated prevention of depression and web-based interventions are seen as potentially meeting this need. The value specification stage yielded expected needs of potential participants, comments on the usefulness of the proposed features and comments on two proposed designs of the web-based intervention. The design stage yielded valuable comments on the system, content and service of the web-based intervention.ConclusionsOverall, we found that by developing the technology, we successfully (re)designed the system, content and service of the web-based intervention to match the values of stakeholders. This study has shown the importance of a structured development process of a web-based intervention for the indicated prevention of depression because: (1) it allows the development team to clarify the needs that have to be met for the intervention to be of use to the target audience; and (2) it yields feedback on the design of the application that is broader than color and buttons, but encompasses comments on the quality of the service that the application offers.

Project description:AimsSchool-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.MethodsWe 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%.ResultsUniversal 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.ConclusionsSchool-based psychological interventions appear to be cost-effective. However, realising efficiency gains in the population is ultimately dependent on ensuring successful system-level implementation.

Project description:BackgroundDepression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students' desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations.ObjectiveThe aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention's effectiveness.MethodsA 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students' use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size.ResultsDirect recruitment through students' email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7).ConclusionsThis report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials.Trial registrationInternational Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk.International registered report identifier (irrid)RR2-10.1186/s13063-018-2477-y.

Project description:IntroductionMajor depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programmes (LMPs), taking into account personal factors and facilitators. The main objective of this protocol is to analyse the clinical effectiveness, cost-effectiveness and cost utility of an LMP and an LMP with information and communication technologies (ICTs) as adjunctive treatment for depression in primary care patients. The secondary objectives are to analyse the clinical effectiveness in the subgroup that presents comorbidity and to analyse the correlation between personal factors on health behaviour and lifestyle patterns.Methods and analysisA randomised, multicenter pragmatic clinical trial with three parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: (1) Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the general practitioner (treatment as usual (TAU)). (2) TAU+LMP. A programme to be imparted in six weekly 90-minute group sessions, intended to improve the following aspects: behavioural activation+daily physical activity+adherence to the Mediterranean diet pattern+sleep hygiene+careful exposure to sunlight. (3) TAU+LMP+ICTs: healthy lifestyle recommendations (TAU+LMP)+monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal factors on health behaviour, social support, lifestyle patterns and chronic comorbid pathology. Data will be collected before and after the intervention, with 6-month and 12-month follow-ups.Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of Aragón (approval number: C.P.-C.I. PI18/286) and the Research Ethics Committee of the Balearic Islands (IB3950/19 PI). Data distribution will be anonymous. Results will be disseminated via conferences and papers published in peer-reviewed, open-access journals.Trial registration numberClinicalTrials.gov Registry (NCT03951350).

Project description:BackgroundAlthough preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking.ObjectiveThe aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN.MethodsWe conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m2≤BMI≤19 kg/m2) and high weight concerns or with normal body weight (19 kg/m2<BMI≤25 kg/m2), high weight concerns, and high restrained eating were recruited from 3 German universities as well as on the web and randomized to Student Bodies-AN (SB-AN; intervention group [IG]) or a wait-list control group (CG). The exclusion criteria were current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-based full-syndrome eating disorders and serious medical or mental problems. The interventions were a cognitive-behavioral guided web-based prevention program (SB-AN) over 10 weeks (IG) and a wait-list CG. The primary outcomes were clinically significant changes in disordered eating attitudes and behaviors and change in BMI at 12-month FU in the group of participants who were underweight. The secondary outcomes were new onset of eating disorders, symptoms of disordered eating, and associated psychopathology.ResultsData were available for 81.5% (137/168) of the women after the intervention and for 69% (116/168) of the women at 12-month FU. At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant. In addition, after the intervention and at 12-month FU, we found a significant increase in continuously measured BMI for the participants who were underweight and significant improvements in disordered eating attitudes and behaviors (eg, restrained eating as well as weight and shape concerns). At all time points, the rates of new-onset eating disorder cases were (nonsignificantly) lower in the IG than in the CG and the reductions in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-based eating disorder syndromes were (nonsignificantly) higher in the IG than in the CG.ConclusionsSB-AN is the first preventive intervention shown to significantly reduce specific risk factors for, and symptoms of, AN and shows promise for reducing full-syndrome AN onset.Trial registrationISRCTN Registry ISRCTN70380261; https://www.isrctn.com/ISRCTN70380261.

Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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