Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID04211753

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

Led by Consorci Sanitari del Maresme · Updated on 2024-09-19

80

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a mobile app called B3RIGHT designed to help people with borderline personality disorder manage emotional crises. This pragmatic randomized controlled trial includes 80 patients, comparing standard treatment alone to standard treatment combined with the mobile app. The study aims to better understand how this technology may assist in crisis management for individuals with this condition. Participants will be divided into two groups: one receiving treatment as usual, which includes weekly group psychotherapy and bimonthly individual psychotherapy, and the other receiving the same treatment plus access to the B3RIGHT mobile app for crisis intervention. The study is conducted in an outpatient setting. Participants are randomly assigned to either group to fairly assess the app's impact when added to standard care. During the 9-month study period, researchers will monitor the number of psychiatric emergencies and hospitalizations as primary outcomes. They will also assess smartphone addiction levels. Participants will be regularly evaluated to track their progress and the safety of using the app alongside their usual therapy. The total participation duration covers the treatment and follow-up needed to capture these outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of borderline personality disorder according to DSM-5
  • Age between 18 and 60 years old
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 9 months

Participants receive weekly group psychotherapy and bimonthly individual psychotherapy in an outpatient setting. Some participants also use a mobile app for crisis intervention.

Weekly group psychotherapy visits and bimonthly individual psychotherapy visits

Follow-up

Duration - Up to 9 months

Participants are monitored for psychiatric emergencies, hospitalizations, and smartphone addiction after treatment.

Periodic assessments during treatment and follow-up

Trial Site Locations

Total: 1 location

1

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain, 08304

Actively Recruiting

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Research Team

M

Mireia Bolivar, PhD

P

Pere Clave, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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