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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Borderline Personality Disorder (BPD)
- 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 group | Role | What they receive |
|---|---|---|
| alivis + TAU | Experimental | Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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.
- First posted19 Sep 2024
- Study start23 Sep 2024
- Primary completion23 Jul 2025
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Philipp Klein, Prof. Dr., Principal investigator, Universität zu Lübeck, Zentrum für Integrative Psychiatrie
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06601907
- Acronym / sponsor ID
- REVALDI-BPD / alivis RCT 2024
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- Digital Intervention, Borderline Personality Disorder, RCT, Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alivis + TAU | Experimental | Behavioral: alivisParticipants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months. |
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alivisalivis 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. | Behavioural | alivis + TAU |
Primary outcome
Borderline Symptoms List 23 (BSL-23)
Time frame: T1 (3 months after randomization)
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.
6 secondary outcomes
Patient Health Questionnaire 9 (PHQ-9)
Time frame: T1 (3 months after randomization)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
Time frame: T1 (3 months after randomization)
Costs Caused Due to the Patients BPD
Time frame: T1 (3 months after randomization)
Work and Social Adjustment Scale (WSAS)
Time frame: T1 (3 months after randomization)
Patient Activation Measure (PAM-13)
Time frame: T1 (3 months after randomization)
Assessment of Quality of Life 8 Dimensions (AQoL-8D)
Time frame: T1 (3 months after randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Philipp Klein, Prof. Dr. principal investigator
Universität zu Lübeck, Zentrum für Integrative Psychiatrie
1 site in 1 country: see every site and its status.
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.