Bipolar DisorderNCT03508427
Toi Même: a Mobile System for Measuring Bipolar Illness
A study testing Daily self-monitoring in people with Bipolar Disorder, run by Institut Pasteur at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Daily self-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesFrance
- Study dates
- 12 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
- Active suicidal ideation or behaviours.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Nightingale Hospitals Paris - Clinique du Château
Garche, 92380
Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)
Meudon, Île-de-France Region, 92190
Centre Hospitalier Sainte Anne
Paris, Île-de-France Region, 75014
About this study
Official title: Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study
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
- Being tested
- Daily self-monitoring
- Keywords
- Bipolar Disorder, Smartphone, Self-monitoring, Objective data
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily self-monitoringOther
Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Daily self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depressive symptoms
Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period.
Measured: 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.
Measured: 3 months study period
Secondary outcomes (8)
Self-rated depressive symptoms
Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 3 months study period.
Measured: 3 months study period
Self-rated manic symptoms
Differences in self-rated manic symptoms using the Altman Mania Self-Rating Scale (ASRM) during the 3 months study period.
Measured: 3 months study period
Activation levels
Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 3 months study period.
Measured: 3 months study period
Treatment adherence
Differences in treatment adherence using the 10-item Medication Adherence Rating Scale (MARS) during the 3 months study period.
Measured: 3 months study period
Functional impairment
Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.
Measured: 3 months study period
Movement behavior
Differences in movement behavior using the smartphone motion sensors during the 3 months study period.
Measured: 3 months study period.
Completion rate
Differences in the completion rate of app self-assessment questionnaires.
Measured: 3 months study period.
Patient acceptance
Patient acceptance rate measured by a questionnaire
Measured: 3 months study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start12 Apr 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Suspended since april 2020 as the application is temporarily unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-arm study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chantal Henry, MD PhD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508427
- Sponsor's protocol ID
- 2017-004
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2017
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32638703
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study
- ClinicalTrials.gov ID
- NCT03508427
- Acronym / sponsor ID
- 2017-004
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Smartphone, Self-monitoring, Objective data
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended since april 2020 as the application is temporarily unavailable
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-arm study
| Arm | Type | Receives |
|---|---|---|
| Toi Même plus treatment as usual | Experimental | Other: Daily self-monitoringOne-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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
- Active suicidal ideation or behaviours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily self-monitoringToi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment. | Other | Toi Même plus treatment as usual |
Primary outcome
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.
8 secondary outcomes
Self-rated depressive symptoms
Time frame: 3 months study period
Self-rated manic symptoms
Time frame: 3 months study period
Activation levels
Time frame: 3 months study period
Treatment adherence
Time frame: 3 months study period
Functional impairment
Time frame: 3 months study period
Movement behavior
Time frame: 3 months study period.
Completion rate
Time frame: 3 months study period.
Patient acceptance
Time frame: 3 months study period.
Results and safety
The study was stopped early (reason given: Suspended since april 2020 as the application is temporarily unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 32638703Dargel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Henry, MD PhD principal investigator
Institut Pasteur
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily self-monitoring in people with Bipolar Disorder, run by Institut Pasteur at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suspended since april 2020 as the application is temporarily unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depressive symptoms (time frame: 3 months study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.