Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation

NCT ID: NCT04210648

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2028-10-31

Brief Summary

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To assess the effectiveness and security of a mobile App (beta version) for people with borderline traits recruited from a non-clinical population of college students in Barcelona (Spain). The main primary outcome will be the severity of the emotional dysregulation. Forty participants will use the mobile app over 6 months. This group while be compared at post-treatment and at 3-month follow-up with other 40 participants (control group) with any intervention.

Detailed Description

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Conditions

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Emotional Dysregulation

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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Intervention group

Those who will use the mobile app

Group Type EXPERIMENTAL

Mobile app

Intervention Type DEVICE

Mobile app for self-managing emotional dysregulation

Non-intervention group

Those who will not use the mobile app

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile app

Mobile app for self-managing emotional dysregulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Borderline traits
* Aged between 18 to 65 years
* College students

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ramon Llull

OTHER

Sponsor Role collaborator

Consorci Sanitari del Maresme

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Alvaro Frias

Role: CONTACT

0034689554606

Other Identifiers

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32-16

Identifier Type: -

Identifier Source: org_study_id

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