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Toi Même: a Mobile System for Measuring Bipolar Illness

Primary Purpose

Bipolar Disorder

Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Daily self-monitoring
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder focused on measuring Bipolar Disorder, Smartphone, Self-monitoring, Objective data

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)
  • Centre Hospitalier Sainte Anne
  • Nightingale Hospitals Paris - Clinique du Château

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toi Même plus treatment as usual

Arm Description

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

Outcomes

Primary Outcome Measures

Severity of depressive symptoms
Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 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.

Secondary Outcome Measures

Self-rated depressive symptoms
Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 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.
Activation levels
Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 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.
Functional impairment
Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.
Movement behavior
Differences in movement behavior using the smartphone motion sensors during the 3 months study period.
Completion rate
Differences in the completion rate of app self-assessment questionnaires.
Patient acceptance
Patient acceptance rate measured by a questionnaire

Full Information

First Posted
November 17, 2017
Last Updated
February 1, 2021
Sponsor
Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT03508427
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
Suspended since april 2020 as the application is temporarily unavailable
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Smartphone, Self-monitoring, Objective data

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toi Même plus treatment as usual
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Daily self-monitoring
Intervention Description
Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
Primary Outcome Measure Information:
Title
Severity of depressive symptoms
Description
Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period.
Time Frame
3 months study period
Title
Severity of manic symptoms
Description
Changes in manic symptoms measured using the Young Mania Rating Scale during the 3 months study period.
Time Frame
3 months study period
Secondary Outcome Measure Information:
Title
Self-rated depressive symptoms
Description
Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 3 months study period.
Time Frame
3 months study period
Title
Self-rated manic symptoms
Description
Differences in self-rated manic symptoms using the Altman Mania Self-Rating Scale (ASRM) during the 3 months study period.
Time Frame
3 months study period
Title
Activation levels
Description
Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 3 months study period.
Time Frame
3 months study period
Title
Treatment adherence
Description
Differences in treatment adherence using the 10-item Medication Adherence Rating Scale (MARS) during the 3 months study period.
Time Frame
3 months study period
Title
Functional impairment
Description
Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.
Time Frame
3 months study period
Title
Movement behavior
Description
Differences in movement behavior using the smartphone motion sensors during the 3 months study period.
Time Frame
3 months study period.
Title
Completion rate
Description
Differences in the completion rate of app self-assessment questionnaires.
Time Frame
3 months study period.
Title
Patient acceptance
Description
Patient acceptance rate measured by a questionnaire
Time Frame
3 months study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Henry, MD PhD
Organizational Affiliation
Institut Pasteur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)
City
Meudon
State/Province
Ile De France
ZIP/Postal Code
92190
Country
France
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75014
Country
France
Facility Name
Nightingale Hospitals Paris - Clinique du Château
City
Garche
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32638703
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.
Results Reference
derived

Learn more about this trial

Toi Même: a Mobile System for Measuring Bipolar Illness

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