An interventional study of Priovi and CAU in Borderline Personality Disorder, sponsored by Gaia AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
Among 37 studies in Borderline Personality Disorder with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Borderline Personality Disorder · Germany.
Among the 37 studies in Borderline Personality Disorder with a site in Germany, this one is the 9th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2018, is one of 20 with no phase, and was the 15th registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
Browse Borderline Personality Disorder studies →6 of the 37 studies in Borderline Personality Disorder with a site in Germany are open now. Recruiting first, the newest first:
University Hospital Heidelberg · Sites in Germany
Ages 18–65
Central Institute of Mental Health, Mannheim · Sites in Germany
Ages 18–65
Heidelberg University · Sites in Germany
Ages 18–65
Heidelberg University · Sites in Germany
Ages 18+ · Healthy volunteers
University Hospital, Bonn · Sites in Germany
Ages 18–50 · Healthy volunteers
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 2
First in 1998; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 206 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Median enrollment 120 across the 28 interventional studies, 60 across the 9 observational. Of the 26 that completed or were terminated, 4 (15%) have results posted.
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6 of 37 have an industry lead sponsor. The 10 most frequent:
Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Gaia AG has 2 studies filed under Borderline Personality Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Borderline Personality Disorder with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07639957University Hospital HeidelbergThe Role of Gender in Borderline Personality Disorder | 2026-12-31 |
| NCT06018272Heidelberg UniversityMentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany | 2027-09-30 |
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Among the 37 studies in Borderline Personality Disorder with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which was designed to introduce relevant schema therapy techniques to Persons with Borderline Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized to two groups: (1) a control group, in which they may engage with any BPD treatment (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Priovi and may also use CAU. The primary outcome measure is the score of the Borderline Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month post-baseline.
In the treatment of psychological disorders, web-based self-help programs can be very helpful, especially when combined with psychotherapy. However, up to this point, there are no respective programs for patients with Borderline Personality Disorder (BPD), although this disorder is associated with severe personal suffering and requires time-consuming therapy, which, in many cases, cannot be provided, due to the lack of therapeutic supply.
In this study, treatment effects of the web-based self-help program Priovi on BPD symptom severity when added to treatment as usual will be investigated. Priovi is a comprehensive program, which is conceptually and substantially based on the schema therapeutic approach used in BPD patients. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audios and motivating text messages.
After a phone pre-screen and a diagnostic evaluation conducted by a psychiatrist, 200 patients suffering from BPD will be randomized into either the intervention group or into the waitlist control group. Priovi's duration of use is one year, measuring points will be determined before beginning of treatment (T0) as well as after 3 (T1), 6 (T2), 9 (T3) and 12 months (T4). The primary outcome variable will be the score of the Borderline Personality Disorder Severity Index (BPDSI), a highly reliable external assessment tool measuring BPD severity. Secondary outcome variables will be BPD symptom severity (as assessed by self-ratings), symptom severity of depression and anxiety as well as quality of life. The study will be collaboratively conducted by the University of Lübeck and the GAIA AG in Hamburg.
In this study, Priovi for BPD patients will be tested in a randomized controlled trial. It will be used as add-on therapy combined with any guideline therapy available to the respective patients. In doing so, the following hypothesis will be investigated: Compared to patients, who exclusively receive treatment as usual, the additional use of the self-help program in question will lead to a stronger decrease in BPD symptom severity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Priovi is an Internet-administered intervention for people with BPD.
Behavioral: Priovi · Other: CAU
Additionaly, they will be informed about helpful and free available online self-help-proposals for BPD patients immediately after randomization.
Other: CAU
Priovi is an Internet intervention for people with BPD. Content is continuously adapted to patients' concerns and needs. Priovi is a comprehensive program, which is conceptually and substantially based on the schema therapeutic approach used in BPD patients. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audios and motivating text messages. Techniques to cope with borderline symptoms (e.g., psychoeducation about modes, schemas and basic emotional needs in addition to relevant strategies to weaken, reduce and/or heal maladaptive schemas and modes) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.
Care as Usual: In the CAU/wait list control group, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Priovi after 12 months post-baseline (i.e., wait list with respect to Priovi access).
Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months.
Semi-structured interview assessing BPD symptom frequency and severity
Time frame: Changes from baseline to 3, 6 and 12 months
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)
Self-report depression symptom severity measure. Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
GAD-7 (Generalized Anxiety Disorder Questionnaire)
Self-report anxiety symptom severity measure. Seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score. Anxiety Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-21 severe.
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
EQ-5D (standardized instrument developed by the EuroQol Group as a measure of health-related quality of life.)
Self-report measure of quality of life symptoms.
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
BPD-Checklist short (Borderline personality Disorder Checklist short)
Self-report measure of BPD symptoms.
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
2 Items of CIUS-Long-brief (Compulsive Internet Use Scale)
Adapted self-report measure assessing potential compulsive internet use. two items, each of which is scored 1 to 5, providing a 2 to 10 severity score with higher values representing a worse outcome
Time frame: Assessed at 3, 6, 9 and 12 months.
NEQ (negative effects questionnaire)
Self-report measure of potential negative effects of the treatment. qualitative measure.
Time frame: Assessed at baseline, 3, 6, 9 and 12 months.
Plan to share: Yes — Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
Ran from Jan 2018 to primary completion in Jan 2020, 24 months.
Of 107 interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Borderline Personality Disorder →
Gaia AG