Background
Poor treatment adherence in patients with chronic obstructive pulmonary disease (COPD) or asthma is a global public health concern with severe consequences in terms of patient health and ...societal costs. A potentially promising tool for addressing poor compliance is eHealth.
Objective
This review investigates the effects of eHealth interventions on medication adherence in patients with COPD or asthma.
Methods
A systematic literature search was conducted in the databases of Cochrane Library, PsycINFO, PubMed, and Embase for studies with publication dates between January 1, 2000, and October 29, 2020. We selected randomized controlled trials targeting adult patients with COPD or asthma, which evaluated the effectiveness of an eHealth intervention on medication adherence. The risk of bias in the included studies was examined using the Cochrane Collaboration’s risk of bias tool. The results were narratively reviewed.
Results
In total, six studies focusing on COPD and seven focusing on asthma were analyzed. Interventions were mostly internet-based or telephone-based, and could entail telemonitoring of symptoms and medication adherence, education, counseling, consultations, and self-support modules. Control groups mostly comprised usual care conditions, whereas a small number of studies used a face-to-face intervention or waiting list as the control condition. For COPD, the majority of eHealth interventions were investigated as an add-on to usual care (5/6 studies), whereas for asthma the majority of interventions were investigated as a standalone intervention (5/7 studies). Regarding eHealth interventions targeting medication adherence for COPD, two studies reported nonsignificant effects, one study found a significant effect in comparison to usual care, and three reported mixed results. Of the seven studies that investigated eHealth interventions targeting medication adherence in asthma, three studies found significant effects, two reported nonsignificant effects, and two reported mixed effects.
Conclusions
The mixed results on the effectiveness of eHealth interventions in improving treatment adherence for asthma and COPD are presumably related to the type, context, and intensity of the interventions, as well as to differences in the operationalization and measurement of adherence outcomes. Much remains to be learned about the potential of eHealth to optimize treatment adherence in COPD and asthma.
Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising ...clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care.
E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country).
The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment.
France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.
Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internetand mobile-supported occupational stress-management intervention (iSMI) for employees ...from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS10≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of 181 95% confidence interval (CI) -6043-1042 per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of ϵ0, ϵ1000, ϵ2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.
Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is ...understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression.
This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments.
We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client WAI-SR-C) and depressive symptoms (Patient Health Questionnaire-9 PHQ-9) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client SUS-C) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables.
Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005).
To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance.
ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573.
RR2-10.1186/s13063-016-1511-1.
(1) Background: The use of smartphone-based ecological momentary assessment (EMA) questionnaires in affective disorder research has rapidly increased. Though, a thorough understanding of experienced ...burden of and adherence to EMA is crucial in determining the usefulness of EMA. (2) Methods: Persons with current affective disorders (
= 100), remitted persons (
= 190), and healthy controls (
= 94) participated in a smartphone-based EMA two-week monitoring period. Our primary outcomes were (momentary) perceived burden of and adherence to EMA. (3) Results: In the whole sample, lower positive and higher negative affect were associated with slightly higher levels of perceived momentary burden (B = -0.23 95%CI = -0.27-0.19, B = 0.30 95%CI = 0.24-0.37, respectively). The persons with current affective disorders reported slightly higher levels of experienced momentary burden (Mdn = 1.98 IQR = 1.28-2.57), than the remitted persons (Mdn = 1.64 IQR = 1.11-2.24) and healthy controls (Mdn = 1.28 IQR = 1.04-1.92). Nevertheless, the persons with current affective disorders still showed very high adherence rates (Mdn = 94.3% IQR = 87.9-97.1), at rates on a par with the remitted persons (Mdn = 94.3% IQR = 90.0-97.1) and healthy controls (Mdn = 94.3% IQR = 90.0-98.6). (4) Discussion: Frequent momentary questionnaires of mental well-being are slightly more burdensome to the persons with current affective disorders, but this does not seem to have a negative impact on adherence. Their high rate of adherence to EMA-which was similar to that in remitted persons and healthy controls -suggests that it is feasible to apply (short-duration) EMA.
IntroductionAlthough guided forms of internet-based cognitive–behavioural therapy (iCBT) result in a substantial reduction in depression, it seems that the most scalable way to deliver iCBT is ...without guidance. However, direct evidence on the comparison between guided and self-guided iCBT is scarce. Moreover, it is unclear which types of patients may benefit more from each of these two forms of iCBT. Network meta-analysis (NMA) using individual participant data (IPD) offers a way to assess the relative efficacy of multiple (>2) interventions. Moreover, it maximises our power to detect patient-level characteristics (covariates) that have an important effect on the efficacy of interventions. This protocol describes the procedures of an IPD-NMA, which aims at examining the relative efficacy of guided compared with self-guided iCBT and at identifying predictors and moderators of treatment outcome.Methods and analysisWe will use an existing database on psychotherapies for adult depression to identify eligible studies. This database has been updated up to 1 January 2018, through literature searches in PubMed, Embase, PsycINFO and Cochrane Library. The outcome of this IPD-NMA is reduction in depressive symptoms severity. We will fit the model in a Bayesian setting. After fitting the model, we will report the relative treatment effects for different types of patients, and we will discuss the clinical implications of our findings. Based on the results from the IPD-NMA model, we will develop and validate a personalised prediction model, aiming to provide patient-level predictions about the effects of the interventions.Ethics and disseminationAn ethical approval is not required for this study. The results will be published in a peer-review journal. These results will guide clinical decisions about the most efficient way to allocate iCBT resources, thereby increasing the scalability of this innovative therapeutic approach.
For alcohol, the association with socioeconomic status (SES) is different than for other public health challenges - the associations are complex, and heterogeneous between socioeconomic groups. ...Specifically, the relationship between alcohol consumption per se and adverse health consequences seems to vary across SES. This observation is called the 'alcohol harm paradox'. This study aims to describe different patterns of alcohol use and potential problems. Next, the associations between sub-groups characterized by different patterns of alcohol use and potential problems, and age, gender, educational level, full-time employment, occupational level and income is analysed.
Employing data from the ongoing cross-sectional WIRUS-study, N = 4311 participants were included in the present study. Individual response patterns of the ten-item Alcohol Use Disorders Identification Test (AUDIT) were analysed and latent class analysis (LCA) was used to identify latent groups. Next, the associations between the classes identified in the best fitting LCA-model and sociodemographic factors were analysed and presented.
We identified three classes based on the response patterns on AUDIT. Class 1 was characterised by low-level alcohol consumption and very low probability of negative alcohol-related consequences related to their alcohol consumption. Class 2 was characterised by a higher level of consumption, but despite this, class 2 also had a relatively low probability of reporting negative alcohol-related consequences. Class 3, however, was characterised by high levels of alcohol consumption, and a high probability of reporting negative consequences of their consumption. The classes identified were systematically differentially associated with the included measures of SES, with class 3 characterised by younger age, more males and lower educational attainment.
Our findings highlight the interconnectedness of alcohol consumption and alcohol-related consequences. Furthermore, the identified classes and SES yields further insights into to intricate relationship between various socioeconomic factors, alcohol use patterns and related negative consequences.
The System Usability Scale (SUS) is used to measure usability of internet-based Cognitive Behavioural Therapy (iCBT). However, whether the SUS is a valid instrument to measure usability in this ...context is unclear. The aim of this study is to assess the factor structure of the SUS, measuring usability of iCBT for depression in a sample of professionals. In addition, the psychometric properties (reliability, convergent validity) of the SUS were tested.
A sample of 242 professionals using iCBT for depression from 6 European countries completed the SUS. Confirmatory Factor Analysis (CFA) was conducted to test whether a one-factor, two-factor, tone-model or bi-direct model would fit the data best. Reliability was assessed using complementary statistical indices (e.g. omega). To assess convergent validity, the SUS total score was correlated with an adapted Client Satisfaction Questionnaire (CSQ-3).
CFA supported the one-factor, two-factor and tone-model, but the bi-factor model fitted the data best (Comparative Fit Index = 0.992, Tucker Lewis Index = 0.985, Root Mean Square Error of Approximation = 0.055, Standardized Root Mean Square Residual = 0.042 (respectively χ
(9) = 69.82, p < 0.001; χ
(8)
33.04, p < 0.001). Reliability of the SUS was good (ω = 0.91). The total SUS score correlated moderately with the CSQ-3 (CSQ1 r
= .49, p < 0.001; CSQ2 r
= .46, p < 0.001; CSQ3 r
= .38, p < 0.001), indicating convergent validity.
Although the SUS seems to have a multidimensional structure, the best model showed that the total sumscore of the SUS appears to be a valid and interpretable measure to assess the usability of internet-based interventions when used by professionals in mental healthcare.
Abstract
Background
Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence ...rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
Methods/design
The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach’s effect on motivation, users’ perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit
N
= 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later.
Discussion
The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions.
Trial registration
Netherlands Trial Register (NTR)
NL8110
. Registered on 23 October 2019.
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