About this trial
Testing and validating an e-health (smartphone application) approach to better understand the determinants of day-to-day symptomatology in depression, medication adherence, and treatment efficacy in the goal of maximizing patient care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years;
Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of depression assessed by the Structured Clinical Interview;
Patients started their antidepressant treatment less than 5 days before inclusion;
Patient treated in an outpatient setting;
Disqualifiers
A current mental or psychiatric impairment or disease (schizophrenia, bipolar disorder) that required psychotropic medication or inpatient treatment on a psychiatric ward;
A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
Cognitive deficit and not thus being able to comprehend the informed consent and study procedure;
Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy….);
Trial design
Parallel
Treatments tested in this trial
Smartphone Support System
Device6 weeks smartphone application with daily evaluations
Treatment groups
Trial outcomes
Primary outcomes
A greater clinical response in the active group (smartphone application) comparatively to the comparator group (clinical response was defined as a decline in HDRS-17 score greater than 50%)
HDRS Hamilton Depressive Rating Scale. Changes in HDRS scores of at least 50% at 8 weeks.
Secondary outcomes
Improvement in scores for therapeutic alliance
Measurement by the 4PAS (4-Point Ordinal Alliance Self-Report)
Improvement in scores for medication adherence
Measurement by the MARS (Medical Adherence Rating Scale)
Improvement in scores for Quality of Life
Measurement by the Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form)
Sponsors and contacts
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