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

NCT ID: NCT04211753

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment as usual plus mobile app

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

Group Type EXPERIMENTAL

Treatment as usual (schema therapy)

Intervention Type BEHAVIORAL

weekly group psychotherapy and bimonthly individual psychotherapy

Mobile app

Intervention Type DEVICE

Medical device for crisis intervention

Treatment as usual

Those who will receive naturalistic treatment in outpatient setting but not the mobile app

Group Type ACTIVE_COMPARATOR

Treatment as usual (schema therapy)

Intervention Type BEHAVIORAL

weekly group psychotherapy and bimonthly individual psychotherapy

Interventions

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Treatment as usual (schema therapy)

weekly group psychotherapy and bimonthly individual psychotherapy

Intervention Type BEHAVIORAL

Mobile app

Medical device for crisis intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari del Maresme

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pere Clave

Role: STUDY_DIRECTOR

Consorci Sanitari del Maresme

Locations

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Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mireia Bolivar, PhD

Role: CONTACT

+34937417700

Pere Clave, PhD

Role: CONTACT

+34937417700

Facility Contacts

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Mireia Bolivar

Role: primary

+34937417700

Pere Clave

Role: backup

+34937417700

Other Identifiers

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CEIC 32/16

Identifier Type: -

Identifier Source: org_study_id

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