The BlendedCare Project
Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and lower threshold to implementation.
The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face (FTF) CBT for adult major depressive disorder.
The study is designed as a two-arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of FTF CBT is alternated with six to eight online modules (NoDep). TAU is defined as twelve sessions of FTF CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9).
Additionally, the study will include an economic evaluation. All participants must be eighteen years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by a multilevel mixed effects model using time as independent variable and PHQ-9 as the dependent variable. Baseline scores, weekly measures and three and six-month follow-up scores will all be included using maximum likelihood estimation of all available data.
This study will compare B-CBT and FTF therapy in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted.
ClinicalTrials.gov NCT02796573. Registered June 1st 2016. Currently recruiting participants. The Regional Committees on Health Research Ethics for Southern Denmark: S-20150150 Danish Agency for Data Protection: 2008-58-0035
Lic. Psychologist, PhD. Student