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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

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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)

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline personality disorder
  • Mobile app
  • Crisis intervention
  • Effectiveness
  • Security
03

Who can participate

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

Inclusion criteria

  • DSM-5 (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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Consorci Sanitari del Maresme
    Mataro, Barcelona 08304, Spain
    • Mireia Bolivar · Contact · mbolivar@csdm.cat · +34937417700
    • Pere Clave · Contact · pclave@csdm.cat · +34937417700
    • Alvaro Frias, PhD · Principal investigator
    Recruiting
07

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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