NCT06601907

Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder

Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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. 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.

Conditions

• Borderline Personality Disorder (BPD)

Interventions

Type	Name	Description
BEHAVIORAL	alivis	alivis is an interactive online program for independent use by users with Borderline Personality Disorder. It focuses on recognized treatment elements from Dialectical Behavior Therapy, Schema Therapy, Acceptance and Commitment Therapy, and Mindfulness Self-Compassion Therapy.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-07-23
• Completion: 2025-07-23
• First posted: 2024-09-19
• Last updated: 2026-03-16
• Results posted: 2026-03-16

Locations

1 site across 1 country: Germany