Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder
A legfontosabb adatok
- Ki végzi
- Gaia AG
- Hol
- Németország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 286 fő vett részt
- Kezdés
- 2024. szept. 23.
- Befejezés
- 2025. júl. 23.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- alivis
- A regiszteradat frissítve
- 2026. március 16.
- Miért állt le
- 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.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- alivis + TAUA vizsgált kezelés
Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.
Kezelés: alivis
- TAUNincs vizsgálati kezelés, összehasonlításként
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).
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
- A regiszteradat frissítve
- 2026. március 16.