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Borderline Personality Disorder (BPD)REVALDI-BPDNCT06601907

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

A study testing alivis in people with Borderline Personality Disorder (BPD), run by Gaia AG at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Borderline Personality Disorder (BPD)
What is being tested?
alivis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
1 siteGermany
Study dates
23 Sep 2024to 23 Jul 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 \< 15
  • Current psychiatric day-care or inpatient treatment
  • Prior use of the digital intervention priovi

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • GAIA

    Hamburg, 22085

Other trials in Germany

About this study

Official title: Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial

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.

Being tested
alivis
Keywords
Digital Intervention, Borderline Personality Disorder, RCT, Dialectical Behavior Therapy
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alivisBehavioural

    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.

Study groups in NCT06601907
Study groupRoleWhat they receive
alivis + TAUExperimentalParticipants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.
Receives: Behavioral: alivis
TAUNo interventionParticipants 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: T1 (3 months after randomization)

Secondary outcomes (6)
  1. Patient Health Questionnaire 9 (PHQ-9)

    The PHQ-9 is the 9-item depression module from the full PHQ with comparable sensitivity and specificity, and includes the 9 criteria upon which the diagnosis of DSM-IV depressive disorders is based. Rating is done on a 4-point Likert scale ranging 0 = "not at all" to 3 = "nearly every day". As a severity measure, scores range from 0 to 27 and represent: mild (0-4), moderate (5-9), moderately severe (10-14), and severe depression (≥15). According to several studies, the German version can be considered reliable regarding psychometric standards. Higher total scores indicate greater depressive symptom severity and thus a worse outcome, whereas lower scores indicate fewer depressive symptoms and a better outcome.

    Measured: T1 (3 months after randomization)

  2. Generalized Anxiety Disorder Assessment 7 (GAD-7)

    This self-administered patient questionnaire is used as a screening tool and severity measure for generalized anxiety disorder (GAD). Studies report good reliability, as well as criterion, construct, factorial, and procedural validity. The GAD-7 is scored on a Likert scale ranging from 0 = "not at all" via 1 = "several days" and 2 = "more than half the days" to 3 = "nearly every day", yielding a sum score ranging from 0-21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Higher total scores indicate greater anxiety symptom severity and thus a worse outcome, whereas lower scores indicate fewer anxiety symptoms and a better outcome.

    Measured: T1 (3 months after randomization)

  3. Costs Caused Due to the Patients BPD

    Costs caused due to BPD will be assessed with a self-compiled instrument assessing inpatient and outpatient treatment, support from friends, family and professional services, contacts with members of the judicial authorities and public security, medication, sick leave, and physician/therapist visits during work time. Higher values indicate greater resource utilization and higher costs and thus a worse economic outcome, whereas lower values indicate lower resource use and a better economic outcome.

    Measured: T1 (3 months after randomization)

  4. Work and Social Adjustment Scale (WSAS)

    The WSAS is a 5-item self-report scale to measure social functioning in regard to physical, mental and social health as well as age group referenced competence for performance. The PROM has good psychometric properties with good criterion validity, good sensitivity and strong internal consistency (α = 0.89). Individual items address work, home management, social leisure, private leisure and relationships. Each item is rated on a 9-point Likert scale from 0 = "not at all impaired" to 8 = "very severely impaired". The total score ranges from 0 to 40. Higher total scores indicate greater functional impairment and thus a worse outcome, whereas lower scores indicate less disability and a better outcome.

    Measured: T1 (3 months after randomization)

  5. Patient Activation Measure (PAM-13)

    The PAM-13 assesses patients' active participation in their medical care using 13 items. Items are answered on a Likert scale ranging from 1 = "strongly disagree" to 4 = "strongly agree," yielding a raw total score between 13 and 52. The German version of the PAM-13 (PAM-13-G) is validated and demonstrates good psychometric properties, including good internal consistency (Cronbach's α = 0.84). In this study, raw scores were converted into the standardized 0-100 patient activation score using a min-max transformation, with higher scores indicating greater patient activation and thus a better outcome.

    Measured: T1 (3 months after randomization)

  6. Assessment of Quality of Life 8 Dimensions (AQoL-8D)

    The AQoL-8D is a health-related quality-of-life questionnaire consisting of 35 items forming eight health dimensions: independent living, happiness, mental health, coping, relationships, self worth, pain, senses. Validation of the AQoL-8D assessing health-related quality of life showed good psychometric properties in a German patient sample, including excellent reliability (Cronbach's α = 0.96) and construct validity (strong correlation with the SF-36, r = .81). The AQoL-8D score ranges from 0-100; higher scores indicating higher quality of life.

    Measured: T1 (3 months after randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start23 Sep 2024
  3. Primary completion23 Jul 2025
  4. Study completion23 Jul 2025

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601907
Sponsor's protocol ID
alivis RCT 2024
Acronym
REVALDI-BPD
Status last verified
Feb 2026
First submitted
16 Sep 2024
Last updated
16 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing alivis in people with Borderline Personality Disorder (BPD), run by Gaia AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Borderline Symptoms List 23 (BSL-23) (time frame: T1 (3 months after randomization)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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