JMIR Publications

ABSTRACT

Background:

Cognitive Behavioral Therapy (CBT) is widely used to treat depression within mental health care; however, there are several challenges, such as high costs, long waiting lists, and a shortage of therapists. Blended CBT (bCBT) combines face-to-face sessions with internet and smartphone structured treatment modules and may help to resolve these issues.

Objective:

The European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED) study, conducted across nine European countries, is the first large-scale comparative blended care study. The hypothesis was that bCBT is clinically non-inferior and cost-effective when compared to Treatment as Usual (TAU), which mainly consisted of face-to-face CBT.

Methods:

A multi-site RCT was conducted with a preset non-inferiority clinically mean full margin of d = 0.20. The main inclusion criteria were individuals aged ≥ 18 years with a diagnosis of major depression (MDD) based on the M.I.N.I. and a baseline Patient Health Questionnaire-9 (PHQ-9) score of ≥ 5. The primary outcome was the PHQ-9, with secondary outcomes including MDD remission after twelve months, quality-adjusted life years, therapeutic alliance, system usability, and costs. Intention-to-treat (ITT) analyses were performed, while linear mixed modelling (LMM) was utilized to assess the intervention effects. Cost-effectiveness analyses were conducted from a healthcare perspective.

Results:

A total of 835 patients were included in the study. bCBT was shown to be non-inferior to TAU concerning the primary PHQ-9 outcome during treatment (three months after the baseline assessment (d: -0.26; 95% CI (-0.43, -0.09)), at six months (post-treatment, d: -0.21 (-0.39, -0.04)), and at twelve-months follow-up d: -0.01 (-0.19, 0.17)). Furthermore, the bCBT group had a significantly lower likelihood of experiencing an MDD episode after twelve months (OR: 0.67, CI: 0.45, 0.99). AD usage was evenly distributed between the two groups (approximately 40%). Subgroup analyses indicated that participants with and without AD usage at baseline in both groups benefited equally from their treatment. Deterioration rates, which were assessed using the reliable change index, were low for both groups (i.e. less than 5%). bCBT appeared acceptable for patients and therapists, as it exhibited a strong working alliance in both groups. From a healthcare perspective, bCBT was not considered cost-effective at the 12-month assessment point, as the total costs of bCBT were not significantly lower than TAU. However, the probability that bCBT is cost-effective is high (0.95), with a willingness to pay (WTP) of €3,800 per improvement in the PHQ-9 score and 0.76 at a WTP of €10,000 per MDD case prevented.

Conclusions:

bCBT may offer an effective clinical alternative to TAU for both MDD patients and their therapists in routine care settings. The perception of bCBT’s cost-effectiveness from a healthcare perspective depends on how much policymakers are willing to invest to achieve one additional unit of clinical benefit. Clinical Trial: Denmark: ClinicalTrials.gov NCT02796573. Registered on June 1, 2016. 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 The study was conducted in accordance with the Declaration of Helsinki, and all researchers followed the guidelines for Good Clinical Practice (Agency, 2016).