Clinical trial NCT03418142: Evaluating an Internet-Based Self-Management Intervention for Borderline
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University of Luebeck
First posted: 2018-02-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Psychotic disorder
* Primary psychiatric diagnosis of an addictive disorder
* Schizotypal personality disorder

Primary outcomes:
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.
timeFrame: Changes from baseline to 3, 6 and 12 months
Secondary outcomes:
measure: Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)
timeFrame: Changes from baseline to 3, 6, 9 and 12 months.
measure: GAD-7 (Generalized Anxiety Disorder Questionnaire)
timeFrame: Changes from baseline to 3, 6, 9 and 12 months.
measure: EQ-5D (standardized instrument developed by the EuroQol Group as a measure of health-related quality of life.)
timeFrame: Changes from baseline to 3, 6, 9 and 12 months.
measure: BPD-Checklist short (Borderline personality Disorder Checklist short)
timeFrame: Changes from baseline to 3, 6, 9 and 12 months.
measure: 2 Items of CIUS-Long-brief (Compulsive Internet Use Scale)
timeFrame: Assessed at 3, 6, 9 and 12 months.
measure: NEQ (negative effects questionnaire)
timeFrame: Assessed at baseline, 3, 6, 9 and 12 months.
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Gaia AG
Study officials:
affiliation: University of Lübeck, Zentrum für Integrative Psychiatrie ZiP gGmbH
name: Jan Philipp Klein, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Storebo 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.
citation: Klein 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.