Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder (REVALDI-BPD)

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.

Study Overview

• Status: Terminated
• Conditions: Borderline Personality Disorder (BPD)
• Intervention / Treatment: Behavioral: alivis

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22085
    • GAIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alivis + TAU; Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.	Behavioral: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T1 (3 months after randomization)
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.	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.	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.	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.	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.	T1 (3 months after randomization)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T2 (6 months after randomization); T3 (12 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.	T2 (6 months after randomization); T3 (12 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.	T2 (6 months after randomization); T3 (12 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.	T2 (6 months after randomization); T3 (12 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.	T2 (6 months after randomization); T3 (12 months after randomization)
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.	T2 (6 months after randomization); T3 (12 months after randomization)
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.	T2 (6 months after randomization); T3 (12 months after randomization)

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: Zentrum für Integrative Psychiatrie
• Investigators: Principal Investigator: Jan Philipp Klein, Prof. Dr., Universität zu Lübeck, Zentrum für Integrative Psychiatrie

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): July 23, 2025
• Study Completion (Actual): July 23, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Borderline Personality Disorder; RCT; Dialectical Behavior Therapy; Digital Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: alivis RCT 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No