TerminatedNot Applicable

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

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.

Germany286 participantsStarted 2024-09-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Borderline Symptoms List 23 (BSL-23)

Timeframe: T1 (3 months after randomization)

Trial details

NCT IDNCT06601907

SponsorGaia AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-23

Results submitted2026-01-15