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

Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation in a Non-Clinical Population With Borderline Traits: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emotional Dysregulation
• Intervention / Treatment: Device: Mobile app

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Those who will use the mobile app	Device: Mobile app; Mobile app for self-managing emotional dysregulation
No Intervention: Non-intervention group; Those who will not use the mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme
• Collaborators: University Ramon Llull

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 32-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No