Evaluating an Internet-Based Self-Management Intervention for Borderline

Borderline Personality Disorder Clinical Trial

— REVISIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418142
• Other study ID #: REVISIT-BPD Trial
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: January 29, 2020

Study information

• Verified date: February 2020
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Priovi
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.

Other:
• CAU
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).

Locations

Country	Name	City	State
Germany	Gaia AG	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Gaia AG	University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Changes from baseline to 3, 6, 9 and 12 months.
Secondary	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.	Changes from baseline to 3, 6, 9 and 12 months.
Secondary	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.	Changes from baseline to 3, 6, 9 and 12 months.
Secondary	BPD-Checklist short (Borderline personality Disorder Checklist short)	Self-report measure of BPD symptoms.	Changes from baseline to 3, 6, 9 and 12 months.
Secondary	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	Assessed at 3, 6, 9 and 12 months.
Secondary	NEQ (negative effects questionnaire)	Self-report measure of potential negative effects of the treatment.; qualitative measure.	Assessed at baseline, 3, 6, 9 and 12 months.