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

NCT03678194 | Recruiting

• 1 other identifier: 2018 A01465-50
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Psychiatric Disorder; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Keywords

Depression; Smartphone; Relapse prevention; Mobile support system; eHealth; Ecological; Randomized; Multicentric

Outcome Measures

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.

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

Secondary Outcomes (3)

• Improvement in scores for therapeutic alliance

  baseline (pre-treatment). 8 weeks post-baseline

• Improvement in scores for medication adherence

  8 weeks after enrollment

• Improvement in scores for Quality of Life

  8 weeks after enrollment

Study Arms (2)

Smartphone application

EXPERIMENTAL

This group of subjects receives mobile support system and conventional treatment (clinical evaluation and follow-up). The smartphone application will be downloaded on patients' smartphone to daily evaluate symptomatology, medication adherence…

Device: Smartphone Support System

Standard services

NO INTERVENTION

This group of patients receives conventional treatment only. Clinical evaluations are provided at the same endpoint. Patients still receive standard services for depression.

Interventions

Smartphone Support System DEVICE

6 weeks smartphone application with daily evaluations

Smartphone application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patient treated in an outpatient setting;
• Patient informed of the diagnosis of his disease;
• Informed patient with written consent.

You may not qualify if:

• 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….);
• Non-comprehension of the French language

Sponsors & Collaborators

• Centre Hospitalier Charles Perrens, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Depression; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

David MISDRAHI, M.D

CONTACT

+33(0)556563449; dmisdrahi@ch-perrens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 200 patients with a DSM-V diagnosis of depression are recruited. Patients are randomly assigned to receive either a 6 weeks smartphone application with daily evaluations, or no application.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: October 14, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)