Clinical trial NCT06601907: Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder
Official title: Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder (BPD)
Keywords: Digital Intervention
Borderline Personality Disorder
RCT
Dialectical Behavior Therapy
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: Zentrum fÃ¼r Integrative Psychiatrie
First posted: 2024-09-19
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ≥ 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 \&lt;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.


Eligibility criteria: 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 \&lt; 15
* Current psychiatric day-care or inpatient treatment
* Prior use of the digital intervention priovi

Primary outcomes:
measure: Borderline Symptoms List 23 (BSL-23)
timeFrame: T1 (3 months after randomization)
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: T1 (3 months after randomization)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: T1 (3 months after randomization)
measure: Costs caused due to the patients BPD
timeFrame: T1 (3 months after randomization)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: T1 (3 months after randomization)
measure: Patient Activation Measure (PAM-13)
timeFrame: T1 (3 months after randomization)
measure: Assessment of Quality of Life 8 Dimensions (AQoL-8D)
timeFrame: T1 (3 months after randomization)
Other outcomes:
measure: Assessment of Quality of Life 8 Dimensions (AQoL-8D)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Patient Activation Measure (PAM-13)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Costs caused due to the patients BPD
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
measure: Borderline Symptoms List 23 (BSL-23)
timeFrame: T2 (6 months after randomization); T3 (12 months after randomization)
Locations:
city: Hamburg
country: Germany
facility: GAIA
Study officials:
affiliation: Universität zu Lübeck, Zentrum für Integrative Psychiatrie
name: Jan Philipp Klein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: