Clinical Trials Directory

Trials / Terminated

TerminatedNCT03508427

Toi Même: a Mobile System for Measuring Bipolar Illness

Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Institut Pasteur · Industry
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2018-04-12
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2018-04-25
Last updated
2023-12-19

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03508427. Inclusion in this directory is not an endorsement.