Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601907
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Researching the Effectiveness of a Alivis a Digital Health Application for Borderline Personality Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Researching the Effectiveness of a Alivis a Digital Health Application for Borderline Personality Disorder a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVALDI-BPD
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 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 107 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 lt15 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 n235 or to a control group in which they will receive access to TAU n235
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 patients BPD social functioning health-related quality of life and patient activation
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 n235 or to a control group in which they will receive access to TAU n235
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 patients BPD social functioning health-related quality of life and patient activation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None