Emotional DysregulationNCT04210648
Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation
A study testing Mobile app in people with Emotional Dysregulation, run by Consorci Sanitari del Maresme.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Dysregulation
- What is being tested?
- Mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Borderline traits
- Aged between 18 to 65 years
- College students
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appDevice
Mobile app for self-managing emotional dysregulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Those who will use the mobile app Receives: Device: Mobile app |
| Non-intervention group | No intervention | Those who will not use the mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 9-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Collaborators
- University Ramon Llull
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210648
- Sponsor's protocol ID
- 32-16
- Status last verified
- Sep 2024
- First submitted
- 19 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04210648
- Acronym / sponsor ID
- 32-16
- Conditions
- Emotional Dysregulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Collaborators
- University Ramon Llull
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Mobile appThose who will use the mobile app |
| Non-intervention group | No intervention | –Those who will not use the mobile app |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Borderline traits
- Aged between 18 to 65 years
- College students
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile appMobile app for self-managing emotional dysregulation | Device | Intervention group |
Primary outcome
Emotion dysregulation severity
Time frame: 9-month
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).
smartphone addiction
Time frame: 9-month
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app in people with Emotional Dysregulation, run by Consorci Sanitari del Maresme.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Frias (0034689554606, afrias@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion dysregulation severity (time frame: 9-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.