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

Depression Clinical Trial

— SMART  

Official title:

Treating Depression on a Day-to-day Basis: Development of a Novel Clinical Tool for Physicians Based on a Smartphone Application, the SMART Project (Smartphones and Mood Disorders, an Application for Research and Treatment)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03678194
• Other study ID #: 2018 A01465-50
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: David MISDRAHI, M.D
• Phone: +33(0)556563449
• Email: dmisdrahi[@]ch-perrens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In industrialized countries, depression is the leading cause of disability with a cumulative DALY (disability adjusted life years) that his greater than all the other psychiatric or medical conditions (WHO, 2004). Although the medical treatment is efficient for a large number of patients, two major pitfalls can be highlighted: i). the difficulty to identify and alter risk factors related to therapeutic observance; and ii). the heterogeneous presentation of depression, which may require specific interventions depending on the clinical presentation of the patient.

Ecological Momentary Assessment (EMA; also referred to as the Experience Sampling Method) is a method used to gather and interpret real-time data collected in the contexts of daily life through mobile technologies (Stone 1994). It has been used extensively in the field of psychiatry and specifically in mood disorders and it has been shown to be both feasible for patients with depression (Husky 2010, Swendsen 2012) and effective in identifying determinants of mood fluctuations and medication observance (Myin Germeys 2003, Ebner-Primer 2009, Solhan 2009, Silk 2011, Wichers 2010, Rot 2012, Armey 2015, Wenze 2010, Armey 2015). The restitution of the data to patients also has an important added benefit in terms of prognosis, as patients are better integrated in their own care (Wichers 2011, Kramer 2014).

Although EMA has been shown to offer promising advantages, it has also been limited by the technical solutions used to gather information on daily life experiences. Rather than using research-dedicated devices which represent the majority of existing tools, the development of an application-based solution could revolutionize the field by creating the first effective and widely-diffusable tool to help clinicians better manage depression with the collaboration of their patients. This application would be designed to help patients monitor their symptoms, while providing regular interventions to increase medication.

This is a randomized study in two groups to test and validate 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.

In this multicentric study, 200 patients with a DSM-V diagnosis of depression are recruited.

Participants will be assessed by:

• Hetero-evaluations: diagnostic (MINI), depressive symptomatology (HDRS), clinical impression (CGI).

• Auto-evaluations: depressive symptomatology (BDI), medication adherence (MARS), Quality of Life (Q-LES-Q-SF), therapeutic alliance (4PAS).

Two groups will be formed by randomization (100 per groups):

• Groupe SMART: smartphone (experimental group). This group will performed all clinical evaluations and will download the study application on their smartphone to answer daily questionnaires about symptom severity, medication adherence, during 6 weeks. Participants will be given a smartphone, if the subject does not have one. Clinical visits with psychiatrist will be performed every two weeks, with questionnaires to fill.

• Groupe TAU: Treatment as Usual (control group). This group will performed all clinical evaluations and have the same follow-up as the intervention group, but without smartphone application.

Expected results Patient benefit: The principle expected benefit for patients concerns their more active participation in their own health care, in the philosophy that the better they understand their disorder and the triggers of symptom expression, the better than can intervene to improve their mental health.

Clinician benefit: It can provide high resolution data of depressive symptoms, therapeutic adherence and symptoms fluctuations on his patients, to better follow the remission or to adjust treatment daily dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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;

• Patient informed of the diagnosis of his disease;

• Informed patient with written consent.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Depression
• Depressive Disorder
• Mental Disorders
• Nervous System Diseases
• Problem Behavior
• Psychiatric Disorder

Intervention

Device:
• Smartphone Support System
6 weeks smartphone application with daily evaluations

Locations

Country	Name	City	State
France	Centre Hospitalier Charles PERRENS	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in scores for therapeutic alliance	Measurement by the 4PAS (4-Point Ordinal Alliance Self-Report)	baseline (pre-treatment). 8 weeks post-baseline
Secondary	Improvement in scores for medication adherence	Measurement by the MARS (Medical Adherence Rating Scale)	8 weeks after enrollment
Secondary	Improvement in scores for Quality of Life	Measurement by the Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form)	8 weeks after enrollment