Dataset Information

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.

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 (F_3,248= 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.

SUBMITTER: Klein JP

PROVIDER: S-EPMC8438831 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDrugs are widely used in borderline personality disorder (BPD) treatment, chosen because of properties known from other psychiatric disorders ("off-label use"), mostly targeting affective or impulsive symptom clusters.ObjectivesTo assess the effects of drug treatment in BPD patients.Search strategyWe searched bibliographic databases according to the Cochrane Developmental, Psychosocial and Learning Problems Group strategy up to September 2009, reference lists of articles, and contacted researchers in the field.Selection criteriaRandomised studies comparing drug versus placebo, or drug versus drug(s) in BPD patients. Outcomes included total BPD severity, distinct BPD symptom facets according to DSM-IV criteria, associated psychopathology not specific to BPD, attrition and adverse effects.Data collection and analysisTwo authors selected trials, assessed quality and extracted data, independently.Main resultsTwenty-eight trials involving a total of 1742 trial participants were included. First-generation antipsychotics (flupenthixol decanoate, haloperidol, thiothixene); second-generation antipsychotics (aripirazole, olanzapine, ziprasidone), mood stabilisers (carbamazepine, valproate semisodium, lamotrigine, topiramate), antidepressants (amitriptyline, fluoxetine, fluvoxamine, phenelzine sulfate, mianserin), and dietary supplementation (omega-3 fatty acid) were tested. First-generation antipsychotics were subject to older trials, whereas recent studies focussed on second-generation antipsychotics and mood stabilisers. Data were sparse for individual comparisons, indicating marginal effects for first-generation antipsychotics and antidepressants.The findings were suggestive in supporting the use of second-generation antipsychotics, mood stabilisers, and omega-3 fatty acids, but require replication, since most effect estimates were based on single studies. The long-term use of these drugs has not been assessed.Adverse event data were scarce, except for olanzapine. There was a possible increase in self-harming behaviour, significant weight gain, sedation and changes in haemogram parameters with olanzapine. A significant decrease in body weight was observed with topiramate treatment. All drugs were well tolerated in terms of attrition.Direct drug comparisons comprised two first-generation antipsychotics (loxapine versus chlorpromazine), first-generation antipsychotic against antidepressant (haloperidol versus amitriptyline; haloperidol versus phenelzine sulfate), and second-generation antipsychotic against antidepressant (olanzapine versus fluoxetine). Data indicated better outcomes for phenelzine sulfate but no significant differences in the other comparisons, except olanzapine which showed more weight gain and sedation than fluoxetine. The only trial testing single versus combined drug treatment (olanzapine versus olanzapine plus fluoxetine; fluoxetine versus fluoxetine plus olanzapine) yielded no significant differences in outcomes.Authors' conclusionsThe available evidence indicates some beneficial effects with second-generation antipsychotics, mood stabilisers, and dietary supplementation by omega-3 fatty acids. However, these are mostly based on single study effect estimates. Antidepressants are not widely supported for BPD treatment, but may be helpful in the presence of comorbid conditions. Total BPD severity was not significantly influenced by any drug. No promising results are available for the core BPD symptoms of chronic feelings of emptiness, identity disturbance and abandonment. Conclusions have to be drawn carefully in the light of several limitations of the RCT evidence that constrain applicability to everyday clinical settings (among others, patients' characteristics and duration of interventions and observation periods).

Project description:BACKGROUND:Borderline personality disorder (BPD) is associated with an intensive use of mental health services, even in the absence of a full diagnosis. Early symptom detection and intervention may help alleviate adverse long-term outcomes. Iconic Therapy is an innovative manual-driven psychotherapy that treats BPD symptoms in a specific and intensive manner. Preliminary results are promising and the indication is that Iconic Therapy may be effective in reducing BPD symptoms. The aim of this study is to assess how effective Iconic Therapy is compared to Structured Support Therapy in a real clinical setting. METHODS/DESIGN:Our study will be a controlled 12-month pragmatic, two-armed RCT. A total of 72 young people (15 to 25 years old) with suicidal ideation/self-injuring behaviour and BPD traits and symptoms will participate in the study. The subjects will be randomised into two groups: Iconic Therapy or Structured Support Therapy. The participants will be assigned to either group on a 1:1 basis. Both the Iconic Therapy and the Structured Support Therapy programmes consist of 11 weekly sessions delivered by two trained psychologists in a group format of between 8 to 12 outpatients. The primary outcome will be measured by the change in symptom severity. Secondary outcomes include changes in suicidal ideation/ behaviour, non-suicidal self-injury, maladjustment to daily life and cost-effective analysis. The primary outcome will be a decrease in the severity of BPD symptoms as assessed by the Borderline Symptom List (BSL-23). For the clinical evaluation, three study assessments will take place: at baseline, after treatment and at 12-month follow-up. We hypothesise that patients attending the Iconic Therapy group will show a significantly higher reduction in symptoms than those in the Structured Support Therapy group. Data will be analysed using generalised estimating equation (GEE) models. DISCUSSION:By responding to the need for briefer and more comprehensive therapies for BPD, we foresee that Iconic Therapy may provide an alternative treatment whose specific therapeutic principles, visually represented on icons, will overcome classical Structured Support Therapy at reducing BPD symptoms. TRIAL REGISTRATION:NCT03011190.