Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder
Key facts
- Who runs it
- Gaia AG
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 286 people enrolled
- Started
- 23 Sept 2024
- Ended
- 23 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- alivis
- Record updated
- 16 March 2026
- Why it stopped
- An unplanned interim futility analysis was initiated due to differential dropout and participant feedback. The probability of achieving the pre-specified effect size was very low, and following DSMB review, the trial was terminated early.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Plans to change treatment (e.g., psychotherapy, medication) in the upcoming 6 months after inclusion
- 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)
- Prior use of the digital intervention priovi
- Comorbid diagnosis of substance use disorder
- Diagnosis of a physical condition that can cause serious psychiatric symptoms
- Current psychiatric day-care or inpatient treatment
- Acute decompensation of mental health symptoms, e.g. acute manic state or acute suicidality
- BMI \< 15
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 patients with BPD as defined in DSM-5. Inclusion criteria are: male, female or non-binary, age 18-65 years, diagnosis of BPD (confirmed by SCID-5-PD), borderline severity score (cut-off) of ≥ 1.07 on the Borderline Symptoms List 23 (BSL-23), stable treatment (psychotherapy, medication, no treatment, …) for at least 30 days at the time of inclusion, consent to emergency plan for suicidal crises, consent to participation, and sufficient German language skills. Exclusion criteria are: Plans to change in treatment (psychotherapy, medication, …) in the upcoming 6 months after inclusion, comorbid diagnosis of substance use disorder or lifetime diagnosis of psychotic disorder, physical condition that can cause severe psychiatric symptoms, acute decompensation of mental health, BMI \<15, and prior use of the digital intervention priovi.
Read full original descriptionShow less
Patients will be randomized and allocated to either an intervention group, in which they will receive access to alivis in addition to treatment as usual (TAU; n=235), or to a control group, in which they will receive access to TAU (n=235).
The primary endpoint will be BPD symptoms with three months post-allocation (T1) being the primary timepoint for assessment of effectiveness. Six (T2) and twelve (T3) months post-allocation will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, anxiety symptoms, costs caused due to the patient's BPD, social functioning, health-related quality of life, and patient activation.
The 2 groups in the trial
- alivis + TAUTreatment being tested
Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.
Treatment: alivis
- TAUNo study treatment, for comparison
Participants in the control group will receive access to treatment as usual (TAU) only. They will receive access to alivis after their last study visit (T3; 12 months after randomization).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
- Record updated
- 16 March 2026