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

Sponsor

Consorci Sanitari del Maresme (Other)

Overall Status

Recruiting

CT.gov ID

NCT04211753

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Behavioral: Treatment as usual (schema therapy) Device: Mobile app	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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) weekly group psychotherapy and bimonthly individual psychotherapy Device: Mobile app Medical device for crisis intervention
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) weekly group psychotherapy and bimonthly individual psychotherapy

Arm

Intervention/Treatment

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)

weekly group psychotherapy and bimonthly individual psychotherapy

Device: Mobile app

Medical device for crisis intervention

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)

weekly group psychotherapy and bimonthly individual psychotherapy

Outcome Measures

Primary Outcome Measures

Number of psychiatric.emergencies and hospitalizations [9-month]
As reported by computerized clinical charts
smartphone addiction [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).