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Toi Même: a Mobile System for Measuring Bipolar Illness

NCT ID: NCT03508427

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar Disorder Smartphone Self-monitoring Objective data

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One-arm study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Daily self-monitoring

Intervention Type OTHER

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

Interventions

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Daily self-monitoring

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chantal Henry, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur

Locations

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Nightingale Hospitals Paris - Clinique du Château

Garche, , France

Site Status

Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)

Meudon, Île-de-France Region, France

Site Status

Centre Hospitalier Sainte Anne

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32638703 (View on PubMed)

Other Identifiers

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2017-004

Identifier Type: -

Identifier Source: org_study_id