Randomized controlled trial (RCT) to test the superiority of blended cognitive behavioral therapy (bCBT) over standard CBT for unipolar depression in adults

Objectives: This study evaluates the medical benefits of a blended cognitive behavioraltherapy (bCBT) program consisting of standard cognitive behavioral therapy (CBT) and adigital health application (elona therapy), compared to standard CBT for unipolar depressionin adult patients in outpatient psychotherapy.Trial design: A multicenter, randomized, two-arm controlled trial.Methods: A total of 283 adult patients diagnosed with unipolar depression were recruitedfrom psychotherapy practices across Germany and randomized in a 1:1 ratio to receive eitherstandard CBT with the “elona therapy” digital health application (bCBT group) or standardCBT alone (treatment as usual; TAU). Over 12 weeks, we assessed symptoms of depressionand anxiety, quality of life, perceived self-efficacy, depression literacy, treatment adherence,overall disease severity and improvement using standardized questionnaires at baseline (T0)and post-intervention (T1). We hypothesized that the bCBT group would show greaterimprovements across these domains compared to the TAU group. Participants were unawareof the study objective and were provided the information that the study investigates theoptimal timing of the addition of a digital intervention.Results: Patients in the bCBT group improved their symptoms of depression (primaryoutcome), anxiety, quality of life, perceived self efficacy, depression literacy and overalldisease severity significantly better than the TAU group over 12 weeks of treatment. Patientsin the bCBT group had significantly higher treatment adherence, evidenced by higher scoresin patient- and therapist-rated adherence questionnaires, as well as lower drop-out rates andhigher session attendance compared to TAU. The number of adverse events was low, and nomore adverse events were reported in the bCBT group than the TAU group.Conclusions: Results of this trial provide comprehensive evidence of the medical benefits ofthe bCBT program supported by elona therapy compared to the standard CBT treatment.bCBT with elona therapy appears to be a safe treatment option.