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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

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE April 12, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Movement behavior [ Time Frame: 3 months study period. ]
    Differences in movement behavior using the smartphone motion sensors during the 3 months study period.
  • Completion rate [ Time Frame: 3 months study period. ]
    Differences in the completion rate of app self-assessment questionnaires.
  • Patient acceptance [ Time Frame: 3 months study period. ]
    Patient acceptance rate measured by a questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toi Même: a Mobile System for Measuring Bipolar Illness
Official Title  ICMJE Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
One-arm study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Other: Daily self-monitoring
Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
Study Arms  ICMJE 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

Intervention: Other: Daily self-monitoring
Publications * Dargél 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 Même, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 23, 2018)
93
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508427
Other Study ID Numbers  ICMJE 2017-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Pasteur
Study Sponsor  ICMJE Institut Pasteur
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chantal Henry, MD PhD Institut Pasteur
PRS Account Institut Pasteur
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP