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

Borderline Personality Disorder Clinical Trial

— B·RIGHT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211753
• Other study ID #: CEIC 32/16
• Status: Recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Consorci Sanitari del Maresme
• Contact: Mireia Bolivar, PhD
• Phone: +34937417700
• Email: mbolivar[@]csdm.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

• Comorbidity with mental retardation

• Comorbidity with psychotic disorder

• Comorbidity with antisocial personality

• Comorbidity with autism spectrum disorder

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Behavioral:
• Treatment as usual (schema therapy)
weekly group psychotherapy and bimonthly individual psychotherapy

Device:
• Mobile app
Medical device for crisis intervention

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Maresme	Mataro	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of psychiatric.emergencies and hospitalizations	As reported by computerized clinical charts	9-month
Primary	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).	9-month