ClinicalTrials.gg
RecruitingNCT04211753B·RIGHTUpdated Sep 19, 2024

Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder

An interventional study of Treatment as usual (schema therapy) and Mobile app in Borderline Personality Disorder, sponsored by Consorci Sanitari del Maresme. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Borderline Personality Disorder with a site in Spain — 4 open to participants now, 4 under way, none of them phase 3. Borderline Personality Disorder · Spain.

Planned enrollment
11th of 18
80 · median 107
Started
2025
the only one that year
No phase
12 of 19
4 open now
Registered
10th of 19
by date
Lead sponsor
1 of 19
Consorci Sanitari del Maresme

Among the 19 studies in Borderline Personality Disorder with a site in Spain, this one is the 11th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2025, is one of 12 with no phase, and was the 10th registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

4 of the 19 studies in Borderline Personality Disorder with a site in Spain are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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)

03

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline personality disorder
  • Mobile app
  • Crisis intervention
  • Effectiveness
  • Security
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
  • Aged 18-60 yeats old

Exclusion criteria

Exclusion Criteria:

  • Comorbidity with mental retardation
  • Comorbidity with psychotic disorder
  • Comorbidity with antisocial personality
  • Comorbidity with autism spectrum disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Treatment as usual plus mobile app

    Those who will receive naturalistic treatment in outpatient setting and also the mobile app

    Behavioral: Treatment as usual (schema therapy) · Device: Mobile app

  • Active comparator
    Treatment as usual

    Those who will receive naturalistic treatment in outpatient setting but not the mobile app

    Behavioral: Treatment as usual (schema therapy)

Interventions

  • BehavioralTreatment as usual (schema therapy)

    weekly group psychotherapy and bimonthly individual psychotherapy

  • DeviceMobile app

    Medical device for crisis intervention

06

What researchers measure

Primary outcomes

  1. Number of psychiatric.emergencies and hospitalizations

    As reported by computerized clinical charts

    Time frame: 9-month

  2. 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).

    Time frame: 9-month

07

Study locations

1 of 1 sites recruiting
  • Consorci Sanitari del Maresme
    Mataro, Barcelona 08304, Spain
    Recruiting
    • Mireia Bolivar · Contactmbolivar@csdm.cat · +34937417700
    • Pere Clave · Contactpclave@csdm.cat · +34937417700
    • Alvaro Frias, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Mar 2025, 1 month later.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 1 month is below that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2019
First posted
Dec 26, 2019
StartEst.
Feb 2025
Primary completionEst.
Mar 2025
CompletionEst.
Jun 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04211753
Lead sponsor
Consorci Sanitari del Maresme
Responsible party
Sponsor
First posted
Dec 26, 2019
Start date
Feb 2025 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Mireia Bolivar, PhD
Contact
mbolivar@csdm.cat
+34937417700
Pere Clave, PhD
Contact
pclave@csdm.cat
+34937417700
Pere Clave
study director · Consorci Sanitari del Maresme

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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