Toi Même: a Mobile System for Measuring Bipolar Illness

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

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.

Study Overview

• Status: Terminated
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Daily self-monitoring

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garche, France, 92380
    • Nightingale Hospitals Paris - Clinique du Château
  • Ile De France
    • Meudon, Ile De France, France, 92190
      • Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)
    • Paris, Ile De France, France, 75014
      • Centre hospitalier Sainte Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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.

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Chantal Henry, MD PhD, Institut Pasteur

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Smartphone; Self-monitoring; Objective data
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 2017-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No