Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder
NCT ID: NCT06601907
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
470 participants
INTERVENTIONAL
2024-09-23
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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alivis + TAU
Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.
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.
TAU
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).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Zentrum für Integrative Psychiatrie
UNKNOWN
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Philipp Klein, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universität zu Lübeck, Zentrum für Integrative Psychiatrie
Locations
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GAIA
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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alivis RCT 2024
Identifier Type: -
Identifier Source: org_study_id
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