Acceptability and Clinical, Cognitive and Brain Efficacy of the Pilot of a Computerized Psychotherapy Program Based on Behavioural and Cognitive Techniques in the Depressed Patient (STOP DEPRESS)

Depression is a common disease with a high rate of recurrence. It is a major public health problem with significant health costs. World Health Organization estimates that 34 million people worldwide are affected by depression but not treated. Common barriers to accessing care in depression would be: the high cost of therapy, long waiting times, low presence of therapists in some communities, travel difficulties, fear of being "stigmatized", not to mention the presence of negative biases towards psychotherapy. Behavioural and Cognitive Therapies are standardized psychotherapies using operationalized methodologies and offering a pedagogical approach to learning specific change techniques and skills. They are the treatment of choice for many of the mental disorders, including depression, which has been proven effective through numerous scientific studies. They are now recognized by the French Authority for Health as the most scientifically validated psychotherapies and are recommended in particular for the treatment of depression.

In a context of constant development of information technology and the Internet, computer programs and websites concerning health, and in particular mental health, have emerged. Among the mental health programs, Computer Based Cognitive Behavior Therapy programs in English-speaking countries now offer patients remote Internet-based behavioural and cognitive therapies.

These programs, which are not available in France, have been the subject of numerous meta-analyses demonstrating their therapeutic effectiveness. Some of these Computer Based Cognitive Behavior Therapy programs such as Beating The Blues® are recommended by health organizations such as the National Institute of Health and Clinical Excellence in the treatment of depression.

This advent of computerized therapies is part of a movement to raise awareness of the epidemiological extent of mood disorders and the inadequacy of management methods. These "therapist-free" programs are, via an interactive and multimedia interface, an alternative means of care, making it possible to overcome the usual obstacles to accessing care. In our opinion, they represent an important area of research in an increasingly computerized health system.

We propose to study the acceptability and effectiveness of the pilot of a Computer Based Cognitive Behavior Therapy targeting depression developed at the University of Nice Sophia Antipolis; in three dimensions:

1. Clinical: via scales for measuring depressive symptomatology and depression characteristics;
2. Cognitive: via specific scales of cognitive-behavioural dimensions and validated in depression.
3. Neurophysiological: via electroencephalographic markers linked to cognitive processes; The research framework would be that of a prospective trial. This work bridges the gap between neurosciences, neuropsychology and the psychiatric clinic, while at the same time being part of a commitment to research in the field of "e-health".

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Software use

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno GIORDANA, PH; Phone Number: +33 (0)4.92.03.87.75; Email: giordana.b@chu-nice.fr

Study Locations

• France
  • Nice, France, 06001
    • Hôpital Pasteur - Service de Psychiatrie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• French speaking
• Presenting a DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, American Psychiatric Association) diagnosis of major depression
• Subject accepting the study and understanding its constraints

Exclusion Criteria:

• Patient at risk of suicide;
• Patient who does not meet the criteria for a major depressive episode;
• Patient meeting resistance depression criteria (Thase&Rush score > 3);
• Patient meeting the criteria for melancholic depression (DSM-5);
• Patient with "psychotic" elements within the depressive episode;
• Patient with chronic schizophrenic or psychotic comorbidity
• Patient with a depressive episode in bipolar disorder
• Patient with unbalanced epilepsy;
• Patient with a severe, unstable somatic condition;
• Patient with a cognitive impairment that hinders the proper use of the computer tool;
• Pregnant or birthing woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Software user	Other: Software use; The patient will connect to a computerized platform to access the program. The program consists of 5 modules ("lessons"), each lasting approximately 40 minutes. Each module or lesson includes pedagogical assessments and explanations of the problem(s) in question, illustrations, testimonies, tips, exercises and recommended activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	The score varies from 0 to 39. 0 to 3: no depression 4 to 7: slight depression 8 to 15: medium to moderate depression 16 and over: severe depression	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Bruno GIORDANA, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 17-AOI-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No