Status:
RECRUITING
Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
Zentrum für Integrative Psychiatrie
Conditions:
Borderline Personality Disorder (BPD)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized controlled trial (RCT) with 470 patients diagnosed with Borderline Personality Disorder (BPD) aims to investigate the effectiveness of the unguided digital therapeutic alivis for patie...
Eligibility Criteria
Inclusion
- Diagnosis of BPD
- Borderline severity score (cut-off) of ≥ 1.07 on the BSL-23
- Stable treatment (e.g., psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
- Consent to emergency plan for suicidal crises
- Consent to participation
- Sufficient knowledge of the German language
Exclusion
- Plans to change treatment (e.g., psychotherapy, medication) in the upcoming 6 months after inclusion
- Comorbid diagnosis of substance use disorder
- Lifetime diagnosis of psychotic disorder like schizophrenia or schizoaffective disorder (except non-transitory paranoid ideas that can be concomitant with BPD and in which the ability to test reality is mostly preserved)
- Diagnosis of a physical condition that can cause serious psychiatric symptoms
- Acute decompensation of mental health symptoms, e.g. acute manic state or acute suicidality
- BMI \< 15
- Current psychiatric day-care or inpatient treatment
- Prior use of the digital intervention priovi
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT06601907
Start Date
September 23 2024
End Date
September 1 2026
Last Update
September 26 2024
Active Locations (1)
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1
GAIA
Hamburg, Germany, 22085