Dataset Information

A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru.

ABSTRACT:

Background

Mobile health interventions provide significant strategies for improving access to health services, offering a potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development.

Objective

This paper presents the protocol for an economic evaluation conducted alongside 2 randomized controlled trials (RCTs) to evaluate the cost-effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes, hypertension, or both.

Methods

The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions in São Paulo, Brazil (n=880) and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50% reduction in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up, and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (ie, a combination of top-down and bottom-up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios and present 95% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves to compare a range of possible cost-effectiveness thresholds.

Results

The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021.

Conclusions

We expect to assess whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries.

Trial registration

ClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426.

International registered report identifier (irrid)

DERR1-10.2196/26164.

SUBMITTER: Vera Cruz Dos Santos D

PROVIDER: S-EPMC8552099 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceDepression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown.ObjectiveTo investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension.Design, setting, and participantsParticipants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018).InterventionsAn 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima).Main outcomes and measuresThe primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months.ResultsAmong 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant.Conclusions and relevanceIn 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months.Trial registrationClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).

Project description:AimsThe aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression.MethodsAn existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool.ResultsFourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions means generalisations, based on economic evaluation alongside clinical trials, cannot easily be made.ConclusionsThere is some economic evidence underpinning many of the common treatment options for major depression. Wide variability was observed in study outcomes, probably attributable to differences in population, interventions or follow-up periods. For many interventions, only a single economic evaluation alongside clinical trials was identified. Thus, significant economic evidence gaps remain in the area of major depressive disorder.

Project description:BackgroundIn Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.ObjectiveThis study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey.MethodsParticipants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline).ResultsWe will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1).ConclusionsResults from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms.Trial registrationClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7).International registered report identifier (irrid)DERR1-10.2196/13239.

Project description:ObjectiveThis study aims at evaluating the cost-effectiveness and cost-utility of a guided and unguided internet-based intervention for chronic pain patients (ACTonPainguided and ACTonPainunguided) compared with a waitlist control group (CG) as well as the comparative cost-effectiveness of the guided and the unguided version.DesignThis is a health economic evaluation alongside a three-arm randomised controlled trial from a societal perspective. Assessments were conducted at baseline, 9?weeks and 6?months after randomisation.SettingParticipants were recruited through online and offline strategies and in collaboration with a health insurance company.Participants302 adults (?18 years, pain for at least 6?months) were randomly allocated to one of the three groups (ACTonPainguided, ACTonPainunguided, CG).InterventionsACTonPain consists of seven modules and is based on Acceptance and Commitment Therapy. ACTonPainguided and ACTonPainunguided only differ in provision of human support.Primary and secondary outcome measuresMain outcomes of the cost-effectiveness and the cost-utility analyses were meaningful change in pain interference (treatment response) and quality-adjusted life years (QALYs), respectively. Economic evaluation estimates were the incremental cost-effectiveness and cost-utility ratio (ICER/ICUR).ResultsAt 6-month follow-up, treatment response and QALYs were highest in ACTonPainguided (44% and 0.280; mean costs = €6,945), followed by ACTonPainunguided (28% and 0.266; mean costs = €6,560) and the CG (16% and 0.244; mean costs = €6,908). ACTonPainguided vs CG revealed an ICER of €45 and an ICUR of €604.ACTonPainunguided dominated CG. At a willingness-to-pay of €0 the probability of being cost-effective was 50% for ACTonPainguided (vs CG, for both treatment response and QALY gained) and 67% for ACTonPainunguided (vs CG, for both treatment response and QALY gained). These probabilities rose to 95% when society's willingness-to-pay is €91,000 (ACTonPainguided) and €127,000 (ACTonPainunguided) per QALY gained. ACTonPainguided vs ACTonPainunguided revealed an ICER of €2,374 and an ICUR of €45,993.ConclusionsDepending on society's willingness-to-pay, ACTonPain is a potentially cost-effective adjunct to established pain treatment. ACTonPainunguided (vs CG) revealed lower costs at better health outcomes. However, uncertainty has to be considered. Direct comparison of the two interventions does not indicate a preference for ACTonPainguided.Trial registration numberDRKS00006183.

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Project description:BackgroundDepressive symptoms are one of the most common and ever-increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need of help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap.ObjectiveIn the framework of a randomized controlled trial, we aim to investigate the effectiveness, acceptance, and side effects of a self-help smartphone app (MCT & More) based on cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and metacognitive training in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes toward internet- and mobile-based interventions on treatment adherence and effectiveness.MethodsA total of 400 students were recruited via open access websites and randomized to either the intervention group (n=200), who received access to the self-help smartphone app MCT & More for a period of 4 weeks, or to a wait-list control group (n=200). The Patient Health Questionnaire-9 (depression) served as the primary outcome parameter, and the Rosenberg Self-esteem Scale (self-esteem) and the global item of the World Health Organization Quality of Life-abbreviated version (quality of life) served as the secondary outcome parameters. The Attitudes Towards Psychological Online Interventions was used to measure attitudes toward internet- and mobile-based interventions. Outcome expectations were assessed using the Patient Questionnaire on Therapy Expectation and Evaluation, and side effects were assessed using the Inventory for Assessing Negative Effects of Psychotherapy.ResultsPer-protocol (PP), complete-case, and intention-to-treat analyses showed a significantly higher reduction in depressive symptoms (PP: F1,222=3.98; P=.047; d=0.26) and a significantly higher increase in self-esteem (PP: F1,220=8.79; P=.003; d=0.40) in the intervention group than in the wait-list control group. Most participants regularly used the self-help smartphone app (91/120, 75.8%, at least once a week). The more positive the attitude toward internet- and mobile-based interventions (r=0.260; P=.004) and the more positive the outcome expectation (r=0.236; P=.009), the more frequently the self-help smartphone app was used.ConclusionsThe effectiveness of the self-help smartphone app MCT & More was demonstrated among students with depressive symptoms compared with a wait-list control group. The app could be offered regularly as a low-threshold intervention to enhance students' health.Trial registrationGerman Clinical Trials Register DRKS00020941; https://tinyurl.com/pr84w6er.

Project description:BACKGROUND:Work-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant. OBJECTIVE:The aim of this study was to assess the cost-effectiveness of a guided iSMI for employees. METHODS:A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale?22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000). RESULTS:When the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained. CONCLUSIONS:Offering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC. TRIAL REGISTRATION:German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1186/1471-2458-13-655.