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

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment as usual (schema therapy)
Mobile app
Sponsored by
Consorci Sanitari del Maresme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline personality disorder, Mobile app, Crisis intervention, Effectiveness, Security

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Consorci Sanitari del MaresmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment as usual plus mobile app

Treatment as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of psychiatric.emergencies and hospitalizations
As reported by computerized clinical charts
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).

Secondary Outcome Measures

Full Information

First Posted
December 19, 2019
Last Updated
March 7, 2022
Sponsor
Consorci Sanitari del Maresme
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1. Study Identification

Unique Protocol Identification Number
NCT04211753
Brief Title
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder
Acronym
B·RIGHT
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari del Maresme

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline personality disorder, Mobile app, Crisis intervention, Effectiveness, Security

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual plus mobile app
Arm Type
Experimental
Arm Description
Those who will receive naturalistic treatment in outpatient setting and also the mobile app
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Those who will receive naturalistic treatment in outpatient setting but not the mobile app
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (schema therapy)
Intervention Description
weekly group psychotherapy and bimonthly individual psychotherapy
Intervention Type
Device
Intervention Name(s)
Mobile app
Intervention Description
Medical device for crisis intervention
Primary Outcome Measure Information:
Title
Number of psychiatric.emergencies and hospitalizations
Description
As reported by computerized clinical charts
Time Frame
9-month
Title
smartphone addiction
Description
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).
Time Frame
9-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireia Bolivar, PhD
Phone
+34937417700
Email
mbolivar@csdm.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Clave, PhD
Phone
+34937417700
Email
pclave@csdm.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Clave
Organizational Affiliation
Consorci Sanitari del Maresme
Official's Role
Study Director
Facility Information:
Facility Name
Consorci Sanitari del Maresme
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Bolivar
Phone
+34937417700
Email
mbolivar@csdm.cat
First Name & Middle Initial & Last Name & Degree
Pere Clave
Phone
+34937417700
Email
pclave@csdm.cat
First Name & Middle Initial & Last Name & Degree
Alvaro Frias, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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