Clinical trial NCT03508427: Toi Même: a Mobile System for Measuring Bipolar Illness
Official title: Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Smartphone
Self-monitoring
Objective data
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2018-04-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-arm study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Severity of depressive symptoms
timeFrame: 3 months study period
measure: Severity of manic symptoms
timeFrame: 3 months study period
Secondary outcomes:
measure: Self-rated depressive symptoms
timeFrame: 3 months study period
measure: Self-rated manic symptoms
timeFrame: 3 months study period
measure: Activation levels
timeFrame: 3 months study period
measure: Treatment adherence
timeFrame: 3 months study period
measure: Functional impairment
timeFrame: 3 months study period
measure: Movement behavior
timeFrame: 3 months study period.
measure: Completion rate
timeFrame: 3 months study period.
measure: Patient acceptance
timeFrame: 3 months study period.
Other outcomes:
Locations:
city: Meudon
country: France
facility: Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)
state: Ile De France
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
state: Ile De France
city: Garche
country: France
facility: Nightingale Hospitals Paris - Clinique du Château
Study officials:
affiliation: Institut Pasteur
name: Chantal Henry, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dargel AA, Mosconi E, Masson M, Plaze M, Taieb F, Von Platen C, Buivan TP, Pouleriguen G, Sanchez M, Fournier S, Lledo PM, Henry C. Toi Meme, a Mobile Health Platform for Measuring Bipolar Illness Activity: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Aug 18;9(8):e18818. doi: 10.2196/18818.