Treating Depression on a Day-to-day Basis: Development of a Tool for Physicians Based on a Smartphone Application

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Charles Perrens, Bordeaux

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Smartphone Support System

    Device

    6 weeks smartphone application with daily evaluations

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Smartphone applicationExperimental treatment 1 intervention
Group B: Standard servicesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-treatment). 8 weeks post-baseline

Secondary outcomes

1

Improvement in scores for therapeutic alliance

Measurement by the 4PAS (4-Point Ordinal Alliance Self-Report)

Time frame
baseline (pre-treatment). 8 weeks post-baseline
2

Improvement in scores for medication adherence

Measurement by the MARS (Medical Adherence Rating Scale)

Time frame
8 weeks after enrollment
3

Improvement in scores for Quality of Life

Measurement by the Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form)

Time frame
8 weeks after enrollment

Other outcomes

Sponsors and contacts

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