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Evaluating an Internet-Based Self-Management Intervention for Borderline (REVISIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418142
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
University of Luebeck
Information provided by (Responsible Party):
Gaia AG

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Priovi Other: CAU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : January 29, 2020
Actual Study Completion Date : January 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Priovi
Priovi is an Internet-administered intervention for people with BPD.
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).

Active Comparator: Care-as-Usual (CAU) / wait list
Additionaly, they will be informed about helpful and free available online self-help-proposals for BPD patients immediately after randomization.
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).




Primary Outcome Measures :
  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. [ Time Frame: Changes from baseline to 3, 6 and 12 months ]
    Semi-structured interview assessing BPD symptom frequency and severity


Secondary Outcome Measures :
  1. 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. ]

    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.


  2. GAD-7 (Generalized Anxiety Disorder Questionnaire) [ Time Frame: Changes from baseline to 3, 6, 9 and 12 months. ]

    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.


  3. 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. ]
    Self-report measure of quality of life symptoms.

  4. BPD-Checklist short (Borderline personality Disorder Checklist short) [ Time Frame: Changes from baseline to 3, 6, 9 and 12 months. ]
    Self-report measure of BPD symptoms.

  5. 2 Items of CIUS-Long-brief (Compulsive Internet Use Scale) [ Time Frame: Assessed at 3, 6, 9 and 12 months. ]

    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


  6. NEQ (negative effects questionnaire) [ Time Frame: Assessed at baseline, 3, 6, 9 and 12 months. ]

    Self-report measure of potential negative effects of the treatment.

    qualitative measure.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418142


Locations
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Germany
Gaia AG
Hamburg, Germany, 20144
Sponsors and Collaborators
Gaia AG
University of Luebeck
Investigators
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Principal Investigator: Jan Philipp Klein, Dr. med. University of Lübeck, Zentrum für Integrative Psychiatrie ZiP gGmbH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gaia AG
ClinicalTrials.gov Identifier: NCT03418142    
Other Study ID Numbers: REVISIT-BPD Trial
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders