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

NCT06601907 | Terminated Results DMC

• 1 other identifier: alivis RCT 2024
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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 \<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.

Conditions

Borderline Personality Disorder (BPD)

Keywords

Digital Intervention; Borderline Personality Disorder; RCT; Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Borderline Symptoms List 23 (BSL-23)

  The BSL-23 is a 23-item PROM with good psychometric properties that was validated and tested for reliability in a representative German sample (test-retest reliability r = .82, p \< 0.0001; α = 0.94-0.97; high correlation of total score with general psychological burden and depression) to assess the typical symptomatology and severity of BPD. It refers to the last week and has a range from 0 = "not at all" to 4 = "very strong". Its single factor structure was optimized to reflect levels and changes in severity of BPD-symptomatology based on a mean score. Higher mean scores indicate greater symptom severity and thus a worse outcome, whereas lower scores indicate fewer BPD-related symptoms and a better outcome.

  T1 (3 months after randomization)

Secondary Outcomes (6)

• Patient Health Questionnaire 9 (PHQ-9)

  T1 (3 months after randomization)

• Generalized Anxiety Disorder Assessment 7 (GAD-7)

  T1 (3 months after randomization)

• Costs Caused Due to the Patients BPD

  T1 (3 months after randomization)

• Work and Social Adjustment Scale (WSAS)

  T1 (3 months after randomization)

• Patient Activation Measure (PAM-13)

  T1 (3 months after randomization)

Other Outcomes (7)

• Assessment of Quality of Life 8 Dimensions (AQoL-8D)

  T2 (6 months after randomization); T3 (12 months after randomization)

• Patient Activation Measure (PAM-13)

  T2 (6 months after randomization); T3 (12 months after randomization)

• Work and Social Adjustment Scale (WSAS)

  T2 (6 months after randomization); T3 (12 months after randomization)

Study Arms (2)

alivis + TAU

EXPERIMENTAL

Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.

Behavioral: alivis

TAU

NO INTERVENTION

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).

Interventions

alivis BEHAVIORAL

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.

alivis + TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of BPD
• Borderline severity score (cut-off) of ≥ 1.07 on the BSL-23
• Consent to emergency plan for suicidal crises
• Consent to participation
• Sufficient knowledge of the German language

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaia AG: lead

Study Sites (1)

GAIA

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Gitta Jacob
• Organization: Gaia AG

gitta.jacob@gaia-group.com

+49 40 3510520

Study Officials

• Jan Philipp Klein, Prof. Dr.

  Universität zu Lübeck, Zentrum für Integrative Psychiatrie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 23, 2024
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)