Toi Même: a Mobile System for Measuring Bipolar Illness

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03508427
• Other study ID #: 2017-004
• Status: Terminated
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Daily self-monitoring
Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.

Locations

Country	Name	City	State
France	Nightingale Hospitals Paris - Clinique du Château	Garche
France	Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)	Meudon	Ile De France
France	Centre Hospitalier Sainte Anne	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional impairment	Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.	3 months study period
Secondary	Movement behavior	Differences in movement behavior using the smartphone motion sensors during the 3 months study period.	3 months study period.
Secondary	Completion rate	Differences in the completion rate of app self-assessment questionnaires.	3 months study period.
Secondary	Patient acceptance	Patient acceptance rate measured by a questionnaire	3 months study period.