For E-COMPARED, eight pragmatic Randomised Controlled Trials on the treatment of depression will be conducted in different countries and different care settings. Four trails will be conducted in primary health care in the United Kingdom, Poland, Spain and Germany. In Switzerland, Sweden, France and The Netherlands, the trials will be organised in specialised health services.

Blended

Each trial will consist of a blended treatment condition and a treatment-as-usual (TAU) condition. Blended treatment entails a combination of internet and mobile-based, and face-to-face interventions. For the blended intervention, an internet-based platform will be employed of similar Cognitive Behavioural Treatment (CBT) and monitoring components as in treatment-as-usual.

Hypothesis

The central assumption that will be tested is that both forms of treatment will lead to similar clinical improvements in patients (non-inferior), but that the blended form can be offered at significantly lower costs.

Technology platforms

Besides the internet-based therapy, the ICT platforms will contain:

  1. a mobile phone component, presenting CBT therapies to the patient and enabling daily monitoring of the state of the patient;
  2. an intelligent reasoning system that provides automated tailored feedback to patients and professionals on the basis of patient progress.
  3. the ability to collect data through Ecological Momentary Assessment

Existing internet-based treatment platforms will be adapted to the specific needs of the participating countries and the trial requirements. The following platforms will be used:

ICT4Depression

Developed and evaluated in the FP7 project, ICT4Depression will be used by The Netherlands, France, Poland, Germany and the UK. Sweden will use an adapted version of this platform.

Smiling is Fun

This platform is developed and evaluated in the FP7 project OPTIMI, and will be used by Spain.

Deprexis

Is developed by GAIA and will be used by Switzerland.

Participants

Participants will be recruited from routine mental healthcare settings. Inclusion criteria include, informed consent, aged between 18 and 65 years, and have a diagnosed major depressive disorder according to the DSM-IV. Treatments will include the same basic CBT components, measurement instruments and time points. To strengthen generalisability to routine practice, guidelines for routine practice will be followed.

Numbers and measurements

Each site will include 150 patients; 75 patients per condition. Pooling data of the participating trial sites enables to generate more statistical power for study analyses. In total, 600 participants will be pooled for primary care for depression and 600 patients for secondary depression treatment. Four measurements will take place: at baseline, post treatment (18 weeks) and follow ups at 8 months and at 12 months after the start of the treatment.

Outcomes

Primary clinical outcomes include changes in depression severity and reliable clinical change and recovery. Secondary outcomes include comorbid disorders such as anxiety and dysthymia, health-related quality of life and psychosocial functioning. Also assessed will be patient treatment preference and satisfaction. Economical outcome measurements will include disease-specific treatment response and generic measures of health gains expressed in Quality Adjusted Life Years.