Toi Même: a Mobile System for Measuring Bipolar Illness

Study Overview
=================
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.

Official Title
-----------------
Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Other: Daily self-monitoring


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: One-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toi Même plus treatment as usual<br>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 | Other: Daily self-monitoring<br>* Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depressive symptoms | Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period. | 3 months study period | 
| Severity of manic symptoms | Changes in manic symptoms measured using the Young Mania Rating Scale during the 3 months study period. | 3 months study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rated depressive symptoms | Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 3 months study period. | 3 months study period | 
| Self-rated manic symptoms | Differences in self-rated manic symptoms using the Altman Mania Self-Rating Scale (ASRM) during the 3 months study period. | 3 months study period | 
| Activation levels | Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 3 months study period. | 3 months study period | 
| Treatment adherence | Differences in treatment adherence using the 10-item Medication Adherence Rating Scale (MARS) during the 3 months study period. | 3 months study period | 
| Functional impairment | Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period. | 3 months study period | 
| Movement behavior | Differences in movement behavior using the smartphone motion sensors during the 3 months study period. | 3 months study period. | 
| Completion rate | Differences in the completion rate of app self-assessment questionnaires. | 3 months study period. | 
| Patient acceptance | Patient acceptance rate measured by a questionnaire | 3 months study period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Smartphone, Self-monitoring, Objective data