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

NCT04210648 | Not Yet Recruiting DMC

• 1 other identifier: 32-16
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Emotional Dysregulation

Outcome Measures

Primary Outcomes (2)

• Emotion dysregulation severity

  Severity of emotional dysregulation as measured by a single score from the The DERS scale (Difficulties in Emotion Regulation scale) (range: 0-88; the higher the score, the more severe the emotion dysregulation severity).

  9-month

• smartphone addiction

  Severity of smartphone addiction as measured by the Spanish version of the The Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).

  9-month

Study Arms (2)

Intervention group

EXPERIMENTAL

Those who will use the mobile app

Device: Mobile app

Non-intervention group

NO INTERVENTION

Those who will not use the mobile app

Interventions

Mobile app DEVICE

Mobile app for self-managing emotional dysregulation

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead
• University Ramon Llull: collaborator

Central Study Contacts

Alvaro Frias

CONTACT

0034689554606; afrias@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share