Clinical Effectiveness and Cost-Effectiveness of Blended Treatment for Major Depression Compared With Treatment as Usual Within Routine Care in Europe: A Noninferiority Randomized Controlled Trial

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dc.abstract.enBackground: Cognitive behavioral therapy (CBT) is an effective and widely used treatment for major depressive disorder (MDD). However, access is limited by long waiting lists and a shortage of trained therapists. Evidence-based guided and self-guided digital interventions can address these challenges, but their large-scale adoption in routine primary and specialized mental health care has been slow. Blended CBT (bCBT), combining face-to-face therapy with structured, guided digital treatment modules, may increase treatment capacity while maintaining the benefits of therapist support. Objective: The European Comparative Effectiveness Research on Internet-based Depression Treatment study, conducted across 9 European countries, is the first large-scale comparative bCBT study for MDD. The hypothesis was that bCBT is clinically noninferior and cost-effective when compared with treatment as usual (TAU), which mainly consisted of face-to-face CBT. Methods: A multisite randomized controlled trial was conducted with a noninferiority margin of d=0.20. Main inclusion criteria were age ≥18 years, a diagnosis of MDD based on the Mini International Neuropsychiatric Interview, 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 at 12 months, therapeutic alliance, and costs. Intention-to-treat analyses were performed, and linear mixed modeling was used to assess intervention effects. Cost-effectiveness analyses were conducted from a health care perspective. Results: A total of 835 patients were included in the study. bCBT was shown to be noninferior to TAU on the primary PHQ-9 outcome during treatment (3 months after the baseline assessment, d=−0.26, 95% CI −0.43 to −0.09), at 6 months (posttreatment, d=−0.21, 95% CI −0.39 to−0.04), and at 12-month follow-up (d=−0.01, 95% CI −0.19 to 0.17). Furthermore, the bCBT group had a significantly lower likelihood of experiencing an MDD episode at 12 months (odds ratio 0.67, 95% CI 0.45‐0.99). Subgroup analyses indicated that participants with and with no antidepressant use at baseline in both groups benefited equally from their treatment. Deterioration rates (Reliable Change Index) were below 5% in both groups. bCBT appeared acceptable for patients and therapists, with a strong working alliance in both groups. From a health care perspective, bCBT was not cost-effective at 12 months' assessment, as its total costs were not significantly lower than TAU. However, the probability that bCBT is cost-effective is high (0.95) at a willingness to pay (WTP) of €3800 per improvement in the PHQ-9 score, and 0.76 at a WTP of €10,000 per MDD case prevented (average 2017 exchange rate was €1=US $1.13). Conclusions: bCBT offers an effective and safe digitally supported alternative to face-to-face TAU for patients with MDD and their therapists in routine clinical care. From a health care perspective, its cost-effectiveness depends on policymakers’ WTP for the additional clinical benefits achieved.
dc.affiliationWydział Psychologii w Warszawie
dc.affiliationInstytut Psychologii
dc.affiliationWydział Projektowania w Warszawie
dc.contributor.authorRiper, Heleen
dc.contributor.authorKleiboer, Annet
dc.contributor.authorHoogendoorn, Adriaan
dc.contributor.authorBosmans, Judith
dc.contributor.authorSchulte, Mieke
dc.contributor.authorMathiasen, Kim
dc.contributor.authorHazo, Jean Baptiste
dc.contributor.authorHoltzmann, Jerome
dc.contributor.authorChevreul, Karine
dc.contributor.authorEbert, David Daniel
dc.contributor.authorTitzler, Ingrid
dc.contributor.authorBerking, Mathias
dc.contributor.authorFunk, Burkhardt
dc.contributor.authorvan Schaik, Anneke
dc.contributor.authorKemmeren, Lise
dc.contributor.authorCieślak, Roman
dc.contributor.authorSmoktunowicz, Ewelina
dc.contributor.authorMaj, Anna
dc.contributor.authorBotella, Cristina
dc.contributor.authorGarcia-Palacios, Azucena
dc.contributor.authorBanos, Rosa
dc.contributor.authorHerreo, Rocio
dc.contributor.authorAndersson, Gerhard
dc.contributor.authorTopooco, Naira
dc.contributor.authorVernmark, Kristofer
dc.contributor.authorBerger, Thomas
dc.contributor.authorKrieger, Tobias
dc.contributor.authorCerga-Pashoja, Arlinda
dc.contributor.authorDoukani, Asmae
dc.contributor.authorAraya, Ricardo
dc.contributor.authorKaryotaki, Eirini
dc.contributor.authorKolovos, Spyros
dc.contributor.authorHoogendoorn, Mark
dc.contributor.authorvan Breda, Ward
dc.contributor.authorvan de Ven, Pepijn
dc.contributor.authorRocha, Artur
dc.contributor.authorGonçalves, Gonçalo
dc.contributor.authorCuijpers, Pim
dc.date.access2026-09-24
dc.date.accessioned2026-09-29T11:25:45Z
dc.date.available2026-09-29T11:25:45Z
dc.date.created2026
dc.date.issued2026-09-24
dc.description.abstract<jats:title>Abstract</jats:title> <jats:sec sec-type="background"> <jats:title>Background</jats:title> <jats:p>Cognitive behavioral therapy (CBT) is an effective and widely used treatment for major depressive disorder (MDD). However, access is limited by long waiting lists and a shortage of trained therapists. Evidence-based guided and self-guided digital interventions can address these challenges, but their large-scale adoption in routine primary and specialized mental health care has been slow. Blended CBT (bCBT), combining face-to-face therapy with structured, guided digital treatment modules, may increase treatment capacity while maintaining the benefits of therapist support.</jats:p> </jats:sec> <jats:sec sec-type="objective"> <jats:title>Objective</jats:title> <jats:p>The European Comparative Effectiveness Research on Internet-based Depression Treatment study, conducted across 9 European countries, is the first large-scale comparative bCBT study for MDD. The hypothesis was that bCBT is clinically noninferior and cost-effective when compared with treatment as usual (TAU), which mainly consisted of face-to-face CBT.</jats:p> </jats:sec> <jats:sec sec-type="methods"> <jats:title>Methods</jats:title> <jats:p> A multisite randomized controlled trial was conducted with a noninferiority margin of <jats:italic>d</jats:italic> =0.20. Main inclusion criteria were age ≥18 years, a diagnosis of MDD based on the Mini International Neuropsychiatric Interview, 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 at 12 months, therapeutic alliance, and costs. Intention-to-treat analyses were performed, and linear mixed modeling was used to assess intervention effects. Cost-effectiveness analyses were conducted from a health care perspective. </jats:p> </jats:sec> <jats:sec sec-type="results"> <jats:title>Results</jats:title> <jats:p> A total of 835 patients were included in the study. bCBT was shown to be noninferior to TAU on the primary PHQ-9 outcome during treatment (3 months after the baseline assessment, <jats:italic>d</jats:italic> =−0.26, 95% CI −0.43 to −0.09), at 6 months (posttreatment, <jats:italic>d</jats:italic> =−0.21, 95% CI −0.39 to−0.04), and at 12-month follow-up ( <jats:italic>d</jats:italic> =−0.01, 95% CI −0.19 to 0.17). Furthermore, the bCBT group had a significantly lower likelihood of experiencing an MDD episode at 12 months (odds ratio 0.67, 95% CI 0.45‐0.99). Subgroup analyses indicated that participants with and with no antidepressant use at baseline in both groups benefited equally from their treatment. Deterioration rates (Reliable Change Index) were below 5% in both groups. bCBT appeared acceptable for patients and therapists, with a strong working alliance in both groups. From a health care perspective, bCBT was not cost-effective at 12 months' assessment, as its total costs were not significantly lower than TAU. However, the probability that bCBT is cost-effective is high (0.95) at a willingness to pay (WTP) of €3800 per improvement in the PHQ-9 score, and 0.76 at a WTP of €10,000 per MDD case prevented (average 2017 exchange rate was €1=US $1.13). </jats:p> </jats:sec> <jats:sec sec-type="conclusions"> <jats:title>Conclusions</jats:title> <jats:p>bCBT offers an effective and safe digitally supported alternative to face-to-face TAU for patients with MDD and their therapists in routine clinical care. From a health care perspective, its cost-effectiveness depends on policymakers’ WTP for the additional clinical benefits achieved.</jats:p> </jats:sec>
dc.description.accesstimeat_publication
dc.description.grantnumber603098
dc.description.granttitleE-COMPARED (European Comparative Effectiveness Research on Internet-based Depression Treatment)
dc.description.physical1-24
dc.description.sdgGoodHealthAndWellBeing
dc.description.versionfinal_published
dc.description.volume15
dc.identifier.doi10.2196/72866
dc.identifier.issn1929-073X
dc.identifier.urihttps://share.swps.edu.pl/handle/swps/2568
dc.identifier.weblinkhttps://www.i-jmr.org/2026/1/e72866
dc.languageen
dc.pbn.affiliationpsychologia
dc.rightsCC-BY
dc.rights.questionYes_rights
dc.share.articleOPEN_JOURNAL
dc.subject.enmajor depression disorder
dc.subject.encognitive behavioral therapy
dc.subject.enblended treatment
dc.subject.encost-effectiveness
dc.subject.ennoninferiority randomized controlled trial
dc.subject.endigital mental health
dc.swps.sciencecloudsend
dc.titleClinical Effectiveness and Cost-Effectiveness of Blended Treatment for Major Depression Compared With Treatment as Usual Within Routine Care in Europe: A Noninferiority Randomized Controlled Trial
dc.title.journalInteractive Journal of Medical Research
dc.typeJournalArticle
dspace.entity.typeArticle