Borderline Personality DisorderREVISITNCT03418142
Evaluating an Internet-Based Self-Management Intervention for Borderline
A study testing Priovi and CAU in people with Borderline Personality Disorder, run by Gaia AG at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Priovi and CAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2018to 29 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psychiatric diagnosis of BPD
- BPDSI score of 15 or higher
- Informed consent
- German language proficiency
- Willingness to participate in diagnostic and follow-up assessments as well as to see a -
- Psychiatrist for validation of diagnosis
- 18 years or older
Who cannot join
- Psychotic disorder
- Primary psychiatric diagnosis of an addictive disorder
- Schizotypal personality disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
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.
Read the detailed description
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Priovi, CAU
- 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.
PrioviBehavioural
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.
CAUOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Priovi | Experimental | Priovi is an Internet-administered intervention for people with BPD. Receives: Behavioral: Priovi; Other: CAU |
| Care-as-Usual (CAU) / wait list | Active comparator | Additionaly, they will be informed about helpful and free available online self-help-proposals for BPD patients immediately after randomization. Receives: Other: CAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Changes from baseline to 3, 6 and 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Changes from baseline to 3, 6, 9 and 12 months.
BPD-Checklist short (Borderline personality Disorder Checklist short)
Self-report measure of BPD symptoms.
Measured: 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
Measured: Assessed at 3, 6, 9 and 12 months.
NEQ (negative effects questionnaire)
Self-report measure of potential negative effects of the treatment.
qualitative measure.
Measured: Assessed at baseline, 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start29 Jan 2018
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Luebeck
- Responsible party
- Sponsor
- Investigators
- Jan Philipp Klein, Dr. med., Principal investigator, University of Lübeck, Zentrum für Integrative Psychiatrie ZiP gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418142
- Sponsor's protocol ID
- REVISIT-BPD Trial
- Acronym
- REVISIT
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
Publications
Klein JP, Hauer-von Mauschwitz A, Berger T, Fassbinder E, Mayer J, Borgwardt S, Wellhofer B, Schweiger U, Jacob G. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021 Sep 8;11(9):e047771. doi: 10.1136/bmjopen-2020-047771.
PubMed 34497078Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Klein JP, Hauer A, Berger T, Fassbinder E, Schweiger U, Jacob G. Protocol for the REVISIT-BPD Trial, a Randomized Controlled Trial Testing the Effectiveness of an Internet-Based Self-Management Intervention in the Treatment of Borderline Personality Disorder (BPD). Front Psychiatry. 2018 Sep 21;9:439. doi: 10.3389/fpsyt.2018.00439. eCollection 2018.
PubMed 30298024
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Evaluating the EffectiVeness of Adding an Internet-Based Self-Management Intervention to Usual Care in the Treatment of Borderline Personality Disorder - REVISIT BPD
- ClinicalTrials.gov ID
- NCT03418142
- Acronym / sponsor ID
- REVISIT / REVISIT-BPD Trial
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Luebeck
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Priovi | Experimental | Behavioral: Priovi, Other: CAUPriovi is an Internet-administered intervention for people with BPD. |
| Care-as-Usual (CAU) / wait list | Active comparator | Other: CAUAdditionaly, they will be informed about helpful and free available online self-help-proposals for BPD patients immediately after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Psychiatric diagnosis of BPD
- BPDSI score of 15 or higher
- Informed consent
- German language proficiency
- Willingness to participate in diagnostic and follow-up assessments as well as to see a -
Key exclusion criteria (3 listed)
- Psychotic disorder
- Primary psychiatric diagnosis of an addictive disorder
- Schizotypal personality disorder
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 |
|---|---|---|
| PrioviPriovi 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. | Behavioural | Priovi |
| CAUCare 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). | Other | Care-as-Usual (CAU) / wait list, Priovi |
Primary outcome
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.
Time frame: Changes from baseline to 3, 6 and 12 months
Semi-structured interview assessing BPD symptom frequency and severity
6 secondary outcomes
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
GAD-7 (Generalized Anxiety Disorder Questionnaire)
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.)
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
BPD-Checklist short (Borderline personality Disorder Checklist short)
Time frame: Changes from baseline to 3, 6, 9 and 12 months.
2 Items of CIUS-Long-brief (Compulsive Internet Use Scale)
Time frame: Assessed at 3, 6, 9 and 12 months.
NEQ (negative effects questionnaire)
Time frame: Assessed at baseline, 3, 6, 9 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 34497078Klein JP, Hauer-von Mauschwitz A, Berger T, Fassbinder E, Mayer J, Borgwardt S, Wellhofer B, Schweiger U, Jacob G. Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial. BMJ Open. 2021 Sep 8;11(9):e047771. doi: 10.1136/bmjopen-2020-047771.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 30298024Klein JP, Hauer A, Berger T, Fassbinder E, Schweiger U, Jacob G. Protocol for the REVISIT-BPD Trial, a Randomized Controlled Trial Testing the Effectiveness of an Internet-Based Self-Management Intervention in the Treatment of Borderline Personality Disorder (BPD). Front Psychiatry. 2018 Sep 21;9:439. doi: 10.3389/fpsyt.2018.00439. eCollection 2018.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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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, Dr. med. principal investigator
University of Lübeck, Zentrum für Integrative Psychiatrie ZiP gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Priovi and CAU in people with Borderline Personality Disorder, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 24 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: Changes from baseline to 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418142, which also lists 3 linked publications.
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 24 Feb 2020.