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

Emotional Dysregulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04210648
• Other study ID #: 32-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2021
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Borderline traits

• Aged between 18 to 65 years

• College students

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Emotional Dysregulation

Intervention

Device:
• Mobile app
Mobile app for self-managing emotional dysregulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme	University Ramon Llull

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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