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Not yet recruitingNCT04210648Updated Sep 19, 2024

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

An interventional study of Mobile app in Emotional Dysregulation, sponsored by Consorci Sanitari del Maresme. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Emotional Dysregulation
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Those who will use the mobile app

    Device: Mobile app

  • No intervention
    Non-intervention group

    Those who will not use the mobile app

Interventions

  • DeviceMobile app

    Mobile app for self-managing emotional dysregulation

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 9-month

  2. 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).

    Time frame: 9-month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04210648
Lead sponsor
Consorci Sanitari del Maresme
Collaborators
University Ramon Llull
Responsible party
Sponsor
First posted
Dec 26, 2019
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Sep 19, 2024

Study contacts

Alvaro Frias
Contact
afrias@csdm.cat
0034689554606

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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