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Toi Même: a Mobile System for Measuring Bipolar Illness

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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
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Other: Daily self-monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Movement behavior [ Time Frame: 3 months study period. ]
    Differences in movement behavior using the smartphone motion sensors during the 3 months study period.

  7. Completion rate [ Time Frame: 3 months study period. ]
    Differences in the completion rate of app self-assessment questionnaires.

  8. Patient acceptance [ Time Frame: 3 months study period. ]
    Patient acceptance rate measured by a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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France
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
Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Chantal Henry, MD PhD Institut Pasteur
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03508427    
Other Study ID Numbers: 2017-004
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Bipolar Disorder
Smartphone
Self-monitoring
Objective data
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders