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

NCT04211753 | Recruiting DMC

• 1 other identifier: CEIC 32/16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorder; Mobile app; Crisis intervention; Effectiveness; Security

Outcome Measures

Primary Outcomes (2)

• Number of psychiatric.emergencies and hospitalizations

  As reported by computerized clinical charts

  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).

  9-month

Study Arms (2)

Treatment as usual plus mobile app

EXPERIMENTAL

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

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

Behavioral: Treatment as usual (schema therapy)

Interventions

Treatment as usual (schema therapy) BEHAVIORAL

weekly group psychotherapy and bimonthly individual psychotherapy

Treatment as usual; Treatment as usual plus mobile app

Mobile app DEVICE

Medical device for crisis intervention

Treatment as usual plus mobile app

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
• Aged 18-60 yeats old

You may not qualify if:

• Comorbidity with mental retardation
• Comorbidity with psychotic disorder
• Comorbidity with antisocial personality
• Comorbidity with autism spectrum disorder

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Therapeutics; Schema Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pere Clave

  Consorci Sanitari del Maresme

  STUDY DIRECTOR

Central Study Contacts

Mireia Bolivar, PhD

CONTACT

+34937417700; mbolivar@csdm.cat

Pere Clave, PhD

CONTACT

+34937417700; pclave@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: February 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)