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

September 12, 2024 updated by: Consorci Sanitari del Maresme

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Recruiting
        • Consorci Sanitari Del Maresme
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alvaro Frias, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of psychiatric.emergencies and hospitalizations
Time Frame: 9-month
As reported by computerized clinical charts
9-month
smartphone addiction
Time Frame: 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).
9-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari del Maresme

Investigators

  • Study Director: Pere Clave, Consorci Sanitari Del Maresme

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 32/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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