Toi Même: a Mobile System for Measuring Bipolar Illness

NCT03508427 | Terminated

• 1 other identifier: 2017-004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Smartphone; Self-monitoring; Objective data

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Self-rated depressive symptoms

  3 months study period

• Self-rated manic symptoms

  3 months study period

• Activation levels

  3 months study period

• Treatment adherence

  3 months study period

• Functional impairment

  3 months study period

Study Arms (1)

Toi Même plus treatment as usual

EXPERIMENTAL

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

Interventions

Daily self-monitoring OTHER

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

Toi Même plus treatment as usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
• Active suicidal ideation or behaviours.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (3)

Nightingale Hospitals Paris - Clinique du Château

Garche, 92380, France

Location

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

Meudon, Île-de-France Region, 92190, France

Location

Centre Hospitalier Sainte Anne

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 32638703 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Chantal Henry, MD PhD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One-arm study

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: April 25, 2018
• Study Start: April 12, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)