Borderline Personality DisorderB·RIGHTNCT04211753
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder
A study testing Treatment as usual (schema therapy) and Mobile app in people with Borderline Personality Disorder, run by Consorci Sanitari del Maresme at 1 site in Spain.
Trial summary
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Treatment as usual (schema therapy) and Mobile app
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2025to Jun 2025
- 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
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
- Aged 18-60 yeats old
Who cannot join
- Comorbidity with mental retardation
- Comorbidity with psychotic disorder
- Comorbidity with antisocial personality
- Comorbidity with autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari del Maresme
Mataró, Barcelona, 08304
Mireia Bolivar, +34937417700, mbolivar@csdm.cat
Pere Clave, +34937417700, pclave@csdm.cat
About this study
Official title: Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Self-managing Emotional Crises in People With Borderline Personality Disorder: A Pragmatic Randomized Controlled Trial
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)
- Conditions
- Borderline Personality Disorder
- Being tested
- Treatment as usual (schema therapy), Mobile app
- Keywords
- Borderline personality disorder, Mobile app, Crisis intervention, Effectiveness, Security
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual (schema therapy)Behavioural
weekly group psychotherapy and bimonthly individual psychotherapy
Mobile appDevice
Medical device for crisis intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual plus mobile app | Experimental | Those who will receive naturalistic treatment in outpatient setting and also the mobile app Receives: Behavioral: Treatment as usual (schema therapy); Device: Mobile app |
| Treatment as usual | Active comparator | Those who will receive naturalistic treatment in outpatient setting but not the mobile app Receives: Behavioral: Treatment as usual (schema therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of psychiatric.emergencies and hospitalizations
As reported by computerized clinical charts
Measured: 9-month
smartphone addiction
Severity of smartphone addiction as measured by the Spanish version of the Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).
Measured: 9-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startFeb 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pere Clave, Study director, Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211753
- Sponsor's protocol ID
- CEIC 32/16
- Acronym
- B·RIGHT
- Status last verified
- Sep 2024
- First submitted
- 19 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Self-managing Emotional Crises in People With Borderline Personality Disorder: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04211753
- Acronym / sponsor ID
- B·RIGHT / CEIC 32/16
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline personality disorder, Mobile app, Crisis intervention, Effectiveness, Security
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Dec 2019 (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.
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual plus mobile app | Experimental | Behavioral: Treatment as usual (schema therapy), Device: Mobile appThose who will receive naturalistic treatment in outpatient setting and also the mobile app |
| Treatment as usual | Active comparator | Behavioral: Treatment as usual (schema therapy)Those who will receive naturalistic treatment in outpatient setting but not the mobile app |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
- Aged 18-60 yeats old
Key exclusion criteria (4 listed)
- Comorbidity with mental retardation
- Comorbidity with psychotic disorder
- Comorbidity with antisocial personality
- Comorbidity with autism spectrum disorder
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 |
|---|---|---|
| Treatment as usual (schema therapy)weekly group psychotherapy and bimonthly individual psychotherapy | Behavioural | Treatment as usual, Treatment as usual plus mobile app |
| Mobile appMedical device for crisis intervention | Device | Treatment as usual plus mobile app |
Primary outcome
Number of psychiatric.emergencies and hospitalizations
Time frame: 9-month
As reported by computerized clinical charts
smartphone addiction
Time frame: 9-month
Severity of smartphone addiction as measured by the Spanish version of the Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Pere Clave study director
Consorci Sanitari del Maresme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (schema therapy) and Mobile app in people with Borderline Personality Disorder, run by Consorci Sanitari del Maresme at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mireia Bolivar, PhD (+34937417700, mbolivar@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of psychiatric.emergencies and hospitalizations (time frame: 9-month). 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?
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 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.