Toi Même: a Mobile System for Measuring Bipolar Illness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03508427|
Recruitment Status : Suspended (Suspended since april 2020 as the application is temporarily unavailable)
First Posted : April 25, 2018
Last Update Posted : February 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Other: Daily self-monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One-arm study|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study|
|Actual Study Start Date :||April 12, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Toi Même plus treatment as usual
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
Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
- Severity of depressive symptoms [ Time Frame: 3 months study period ]Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period.
- Severity of manic symptoms [ Time Frame: 3 months study period ]Changes in manic symptoms measured using the Young Mania Rating Scale during the 3 months study period.
- Self-rated depressive symptoms [ Time Frame: 3 months study period ]Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 3 months study period.
- Self-rated manic symptoms [ Time Frame: 3 months study period ]Differences in self-rated manic symptoms using the Altman Mania Self-Rating Scale (ASRM) during the 3 months study period.
- Activation levels [ Time Frame: 3 months study period ]Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 3 months study period.
- Treatment adherence [ Time Frame: 3 months study period ]Differences in treatment adherence using the 10-item Medication Adherence Rating Scale (MARS) during the 3 months study period.
- Functional impairment [ Time Frame: 3 months study period ]Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.
- Movement behavior [ Time Frame: 3 months study period. ]Differences in movement behavior using the smartphone motion sensors during the 3 months study period.
- Completion rate [ Time Frame: 3 months study period. ]Differences in the completion rate of app self-assessment questionnaires.
- Patient acceptance [ Time Frame: 3 months study period. ]Patient acceptance rate measured by a questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508427
|Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)|
|Meudon, Ile De France, France, 92190|
|Centre Hospitalier Sainte Anne|
|Paris, Ile De France, France, 75014|
|Nightingale Hospitals Paris - Clinique du Château|
|Garche, France, 92380|
|Principal Investigator:||Chantal Henry, MD PhD||Institut Pasteur|