Evaluating an Internet-Based Self-Management Intervention for Borderline

NCT03418142 | Completed

• 1 other identifier: REVISIT-BPD Trial
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  Changes from baseline to 3, 6, 9 and 12 months.

• GAD-7 (Generalized Anxiety Disorder Questionnaire)

  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.)

  Changes from baseline to 3, 6, 9 and 12 months.

• BPD-Checklist short (Borderline personality Disorder Checklist short)

  Changes from baseline to 3, 6, 9 and 12 months.

• 2 Items of CIUS-Long-brief (Compulsive Internet Use Scale)

  Assessed at 3, 6, 9 and 12 months.

Study Arms (2)

Priovi

EXPERIMENTAL

Priovi is an Internet-administered intervention for people with BPD.

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.

Other: CAU

Interventions

Priovi BEHAVIORAL

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.

Priovi

CAU OTHER

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).

Care-as-Usual (CAU) / wait list; Priovi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

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

Sponsors & Collaborators

• Gaia AG: lead
• University of Luebeck: collaborator

Study Sites (1)

Gaia AG

Hamburg, 20144, Germany

Location

Related Publications (3)

• 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.

  PMID: 34497078 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 30298024 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Jan Philipp Klein, Dr. med.

  University of Lübeck, Zentrum für Integrative Psychiatrie ZiP gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 1, 2018
• Study Start: January 29, 2018
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)