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

Jan Philipp Klein, Andrea Hauer-von Mauschwitz, Thomas Berger, Eva Fassbinder, Johannes Mayer, Stefan Borgwardt, Bernhard Wellhöfer, Ulrich Schweiger, Gitta Jacob, Jan Philipp Klein, Andrea Hauer-von Mauschwitz, Thomas Berger, Eva Fassbinder, Johannes Mayer, Stefan Borgwardt, Bernhard Wellhöfer, Ulrich Schweiger, Gitta Jacob

Abstract

Importance: Borderline personality disorder (BPD) is a severe mental disorder that is often inadequately treated.

Objective: To determine if adding a self-management intervention to care as usual (CAU) is effective and safe.

Design: Randomised, controlled, rater-blind trial. Duration of treatment and assessments: 12 months.

Setting: Secondary care, recruited mainly via the internet.

Participants: Patients with BPD and BPD Severity Index (BPDSI) of at least 15.

Interventions: CAU by treating psychiatrist and/or psychotherapist alone or adjunctive use of an internet-based self-management intervention that is based on schema therapy (priovi).

Main outcome measure: Outcomes were assessed by trained raters. The primary outcome was change in BPDSI. The safety outcome was the number of serious adverse events (SAEs). The primary outcome time point was 12 months after randomisation.

Results: Of 383 participants assessed for eligibility, 204 were included (91.7% female, mean age: 32.4 years; 74% were in psychotherapy and 26% were in psychiatric treatment). The slope of BPDSI change did not differ significantly between groups from baseline to 12 months (F3,248= 1.857, p=0.14). At 12 months, the within-group effect sizes were d=1.38 (95% CI 1.07 to 1.68) for the intervention group and d=1.02 (95% CI 0.73 to 1.31) for the control group. The between-group effect size was d=0.27 (95% CI 0.00 to 0.55) in the intention-to-treat sample and d=0.39 (95% CI 0.09 to 0.68) for those who used the intervention for at least 3 hours (per-protocol sample). We found no significant differences in SAEs.

Conclusions: We have not found a significant effect in favour of the intervention. This might be due to the unexpectedly large effect in the group receiving CAU by a psychiatrist and/or psychotherapist alone.

Trial registration: NCT03418142.

Keywords: adult psychiatry; clinical trials; personality disorders; suicide & self-harm.

Conflict of interest statement

Competing interests: AH-vM, GJ, JM and BW are employees of GAIA AG, Hamburg, Germany, the company that owns and runs the self-management interventions (SMI) tested in this trial. Both EF and GJ have received payments for training and published books/DVDs on schema therapy (ST) and treatment of borderline personality disorder. AH-vM receives payments for an ST card set published by Beltz. JPK received funding for clinical trials (German Federal Ministry of Health, Servier: distributor of the SMI 'Deprexis'), payments for presentations on internet interventions (Servier) and payments for workshops and books (Beltz, Elsevier and Hogrefe) on psychotherapy for chronic depression and on psychiatric emergencies.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Patient flow. Trial design and flow of patients throughout the assessment time points for the primary outcome measure. BPD, borderline personality disorder; BPDSI, BPD Severity Index; SMI, self-management intervention.
Figure 2
Figure 2
Means and SEs of the BPDSI score from baseline to 12 months. BPDSI, Borderline Personality Disorder Severity Index.

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