The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial

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Abstract

Background

In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual.

Methods/Design

The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments.

Trial registration

Clinical Trial.gov: NCT01512602.

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Most cited references 17

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Borderline personality disorder.

Klaus Lieb, Mary C Zanarini, Christian Schmahl … (2004)

Borderline personality disorder is characterised by a pervasive pattern of instability in affect regulation, impulse control, interpersonal relationships, and self-image. Clinical signs of the disorder include emotional dysregulation, impulsive aggression, repeated self-injury, and chronic suicidal tendencies, which make these patients frequent users of mental-health resources. Causal factors are only partly known, but genetic factors and adverse events during childhood, such as physical and sexual abuse, contribute to the development of the disorder. Dialectical behaviour therapy and psychodynamic partial hospital programmes are effective treatments for out-of-control patients, and drug therapy can reduce depression, anxiety, and impulsive aggression. More research is needed for the understanding and management of this disabling clinical condition. Current strategies are focusing on the neurobiological underpinnings of the disorder and the development and dissemination of better and more cost-effective treatments to clinicians.

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Fatal and non-fatal repetition of self-harm. Systematic review.

David Owens, Judith Horrocks, Allan House (2002)

Non-fatal self-harm frequently leads to non-fatal repetition and sometimes to suicide. We need to quantify these two outcomes of self-harm to help us to develop and test effective interventions. To estimate rates of fatal and non-fatal repetition of self-harm. A systematic review of published follow-up data, from observational and experimental studies. Four electronic databases were searched and 90 studies met the inclusion criteria. Eighty per cent of studies found were undertaken in Europe, over one-third in the UK. Median proportions for repetition 1 year later were: 16% non-fatal and 2% fatal; after more than 9 years, around 7% of patients had died by suicide. The UK studies found particularly low rates of subsequent suicide. After 1 year, non-fatal repetition rates are around 15%. The strong connection between self-harm and later suicide lies somewhere between 0.5% and 2% after 1 year and above 5% after 9 years. Suicide risk among self-harm patients is hundreds of times higher than in the general population.

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Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): a continuous measure of DSM-IV borderline psychopathology.

Mary C Zanarini, Anna A Vujanovic, Elizabeth Parachini … (2003)

The purpose of this study was to assess the psychometric properties of the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), the first clinician-administered scale for the assessment of change in DSM-IV borderline psychopathology. The questions for the measure were adapted from the BPD module of the Diagnostic Interview for DSM-IV Personality Disorders (DIPD-IV) to reflect a 1-week time frame and each of the nine criteria for BPD is rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. Two diagnostic interviews that assess the presence of BPD were administered to 200 nonpsychotic patients: the BPD module of the DIPD-IV and the Revised Diagnostic Interview for Borderlines (DIB-R). The ZAN-BPD was also administered, blind to diagnostic information. In addition, each patient filled out a self-report measure of general psychopathology that is often used in borderline treatment studies, the Symptom Checklist 90 (SCL-90). The convergent validity of the ZAN-BPD and relevant scales of the SCL-90 and the DIB-R was assessed and found to be highly significant. The discriminant validity of the various scores of the ZAN-BPD was also found to be highly significant, easily discriminating the 139 patients who met the DSM-IV criteria for BPD from the 61 patients who did not. In addition, internal consistency of the ZAN-BPD was found to be high (Cronbach's alpha=0.85). The interrater reliability of the ZAN-BPD was assessed using 32 conjoint interviews, while same day test-retest reliability was assessed in a separate sample of 40 patients. All reliability raters were blind to all previously collected information concerning each subject. All intraclass correlations were in the good to excellent range. Finally, the sensitivity of the ZAN-BPD to change was assessed using a third sample of 41 patients who were reinterviewed by a blind rater 7 to 10 days after the ZAN-BPD was first administered. The SCL-90 was also readministered at this time. The correlations between difference scores of the ZAN-BPD and difference scores of the SCL-90 were found to be significant, indicating that the ZAN-BPD measures change in a clinically meaningful manner. Taken together, the results of this study suggest that the ZAN-BPD is a promising clinician-administered scale for the assessment of change in borderline psychopathology over time.

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Author and article information

Contributors

Kate Andreasson

Jesper Krogh

Bent Rosenbaum

Christian Gluud

David A Jobes

Merete Nordentoft

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central

ISSN (Electronic): 1745-6215

Publication date Collection: 2014

Publication date (Electronic): 29 May 2014

Volume: 15

Page: 194

Affiliations

[1 ]Mental Health Centre Copenhagen, Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark

[2 ]Mental Health Services, Copenhagen and Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark

[3 ]Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshopitalet, Copenhagen University Hospital, DK-2100 Copenhagen, Denmark

[4 ]Department of Psychology, The Catholic University of America, Washington, DC, USA

[5 ]Research Unit, Mental Health Centre, Bispebjerg bakke 23, Building 14, DK-2400 Copenhagen, NV, Denmark

Article

Publisher ID: 1745-6215-15-194

DOI: 10.1186/1745-6215-15-194

PMC ID: 4055911

PubMed ID: 24885904

SO-VID: 00eddcdc-7969-46e2-a32c-73ac5f31fc14

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial

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Abstract

Background

Methods/Design

Trial registration

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Herbal Medicines Journal (Herb Med J)

Most cited references 17

Borderline personality disorder.

Fatal and non-fatal repetition of self-harm. Systematic review.

Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): a continuous measure of DSM-IV borderline psychopathology.

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