Toi Même: a Mobile System for Measuring Bipolar Illness

Pasteur Institute

Status: Terminated

Conditions: Bipolar Disorder

Treatments: Other: Daily self-monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT03508427

2017-004

Details and patient eligibility

About

Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.

On the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).

In this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with the current diagnosis of Bipolar disorder type I or type II according to the DSM-5 criteria
• having an iPhone with iOS version from 9.x with access to wireless Internet connectivity.

Exclusion criteria

• Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
• Active suicidal ideation or behaviours.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Toi Même plus treatment as usual

Experimental group

Description:

One-Arm study Intervention: Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment. Tool: Toi Même mobile app

Treatment:

Other: Daily self-monitoring