Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?

Borderline Personality Disorder Clinical Trial

Official title:

Vilka Faktorer påverkar Behandlingsutfall Vid Dialektisk Beteendeterapi för Borderline Personlighetssyndrom?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106555
• Other study ID #: Dnr 2023-03990-01
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Magnus Nilsson, PhD
• Phone: 046174925
• Email: magnus.per.nilsson[@]skane.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this project is to investigate factors that contribute to the success and lack of success in DBT among individuals with BPD and a history of self-harm in a clinical psychiatric setting.

1. Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?

2. Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?

3. Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?

4. When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

Description:

Borderline Personality Disorder (BPD) is a complex and enduring mental health condition characterized by a range of symptoms. The consequences of BPD are severe, causing individual suffering, impairments in daily functioning, and increased mortality rates. Dialectical behavior therapy (DBT) is one of the most widely used treatment models for BPD and self-harm. DBT has demonstrated positive outcomes but not all individuals benefit equally from this therapy, highlighting the need for further exploration. Specifically, there is a knowledge gap regarding what predicts positive treatment response. Research exploring this topic, has highlighted the potential significance of emotion regulation, personality profiles, self-concept, and identity disturbance in understanding the outcomes of individuals with BPD.

The primary objective of this research project is to investigate the factors that contribute to the success and lack of success in DBT.

All individuals referred to DBT-treatment in the Adult psychiatric clinic in Lund will be offered participation in the study. All study participants receive the same treatment as those who chose not to participate. Measures will commence after treatment contracts have been negotiated and the treatment will continue up to a maximum treatment length of one year.

Data will be retrieved from databases, medical records as well as collected as self-report forms. Self-report measures will be conducted every three months, at end of treatment and at follow up 12 months after end of treatment. Data from registries and charts will be collected at time of consent and at follow up 12 months after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Borderline personality disorder as defined by the DSM-V (assessed with SCID or uquivalent).

• Self-harm over the past 12 months

• Offered DBT at the Lund adult psychiatric clinic

Exclusion Criteria:

• Unable to read or communicate in Swedish

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Deliberate Self Harm
• Non-suicidal Self-injury
• Personality Disorders
• Self Mutilation
• Self-Injurious Behavior

Intervention

Behavioral:
• Dialectibal Behaviour Therapy
Standard Dialectical Behaviour Therapy of up to 12 months as described Professor Linehan

Locations

Country	Name	City	State
Sweden	Lund adult psychiatric hospital	Lund	Skåne

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University., Department of Psychology. Lund University., University of Toronto

Country where clinical trial is conducted

Sweden, 

References & Publications (17)

Alvarez-Tomas I, Ruiz J, Guilera G, Bados A. Long-term clinical and functional course of borderline personality disorder: A meta-analysis of prospective studies. Eur Psychiatry. 2019 Feb;56:75-83. doi: 10.1016/j.eurpsy.2018.10.010. Epub 2018 Dec 24. — View Citation

Chen SY, Cheng Y, Zhao WW, Zhang YH. Effects of dialectical behaviour therapy on reducing self-harming behaviours and negative emotions in patients with borderline personality disorder: A meta-analysis. J Psychiatr Ment Health Nurs. 2021 Dec;28(6):1128-1139. doi: 10.1111/jpm.12797. Epub 2021 Sep 20. — View Citation

Cipriano A, Cella S, Cotrufo P. Nonsuicidal Self-injury: A Systematic Review. Front Psychol. 2017 Nov 8;8:1946. doi: 10.3389/fpsyg.2017.01946. eCollection 2017. — View Citation

Ellison WD, Rosenstein LK, Morgan TA, Zimmerman M. Community and Clinical Epidemiology of Borderline Personality Disorder. Psychiatr Clin North Am. 2018 Dec;41(4):561-573. doi: 10.1016/j.psc.2018.07.008. Epub 2018 Oct 16. — View Citation

Gad MA, Pucker HE, Hein KE, Temes CM, Frankenburg FR, Fitzmaurice GM, Zanarini MC. Facets of identity disturbance reported by patients with borderline personality disorder and personality-disordered comparison subjects over 20 years of prospective follow-up. Psychiatry Res. 2019 Jan;271:76-82. doi: 10.1016/j.psychres.2018.11.020. Epub 2018 Nov 10. — View Citation

Gratz KL, Bardeen JR, Levy R, Dixon-Gordon KL, Tull MT. Mechanisms of change in an emotion regulation group therapy for deliberate self-harm among women with borderline personality disorder. Behav Res Ther. 2015 Feb;65:29-35. doi: 10.1016/j.brat.2014.12.005. Epub 2014 Dec 13. — View Citation

Kaufman EA, Meddaoui B. Identity pathology and borderline personality disorder: an empirical overview. Curr Opin Psychol. 2021 Feb;37:82-88. doi: 10.1016/j.copsyc.2020.08.015. Epub 2020 Aug 25. — View Citation

Kroger C, Harbeck S, Armbrust M, Kliem S. Effectiveness, response, and dropout of dialectical behavior therapy for borderline personality disorder in an inpatient setting. Behav Res Ther. 2013 Aug;51(8):411-6. doi: 10.1016/j.brat.2013.04.008. Epub 2013 May 14. — View Citation

Krueger RF, Derringer J, Markon KE, Watson D, Skodol AE. Initial construction of a maladaptive personality trait model and inventory for DSM-5. Psychol Med. 2012 Sep;42(9):1879-90. doi: 10.1017/S0033291711002674. Epub 2011 Dec 8. Erratum In: Psychol Med. 2012 Sep;42(9):1891. — View Citation

Levi FA, Hrushesky WJ, Blomquist CH, Lakatua DJ, Haus E, Halberg F, Kennedy BJ. Reduction of cis-diamminedichloroplatinum nephrotoxicity in rats by optimal circadian drug timing. Cancer Res. 1982 Mar;42(3):950-5. — View Citation

McMain SF, Fitzpatrick S, Boritz T, Barnhart R, Links P, Streiner DL. Outcome Trajectories and Prognostic Factors for Suicide and Self-Harm Behaviors in Patients With Borderline Personality Disorder Following One Year of Outpatient Psychotherapy. J Pers Disord. 2018 Aug;32(4):497-512. doi: 10.1521/pedi_2017_31_309. Epub 2017 Sep 14. — View Citation

Mehlum L. Mechanisms of change in dialectical behaviour therapy for people with borderline personality disorder. Curr Opin Psychol. 2021 Feb;37:89-93. doi: 10.1016/j.copsyc.2020.08.017. Epub 2020 Aug 25. — View Citation

Meuldijk D, McCarthy A, Bourke ME, Grenyer BF. The value of psychological treatment for borderline personality disorder: Systematic review and cost offset analysis of economic evaluations. PLoS One. 2017 Mar 1;12(3):e0171592. doi: 10.1371/journal.pone.0171592. eCollection 2017. — View Citation

Schmitgen MM, Niedtfeld I, Schmitt R, Mancke F, Winter D, Schmahl C, Herpertz SC. Individualized treatment response prediction of dialectical behavior therapy for borderline personality disorder using multimodal magnetic resonance imaging. Brain Behav. 2019 Sep;9(9):e01384. doi: 10.1002/brb3.1384. Epub 2019 Aug 14. — View Citation

van Asselt AD, Dirksen CD, Arntz A, Severens JL. The cost of borderline personality disorder: societal cost of illness in BPD-patients. Eur Psychiatry. 2007 Sep;22(6):354-61. doi: 10.1016/j.eurpsy.2007.04.001. Epub 2007 Jun 4. — View Citation

Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: Update of a brief instrument for assessing level of personality functioning. Personal Ment Health. 2019 Feb;13(1):3-14. doi: 10.1002/pmh.1434. Epub 2018 Sep 19. — View Citation

Woodbridge J, Reis S, Townsend ML, Hobby L, Grenyer BFS. Searching in the dark: Shining a light on some predictors of non-response to psychotherapy for borderline personality disorder. PLoS One. 2021 Jul 27;16(7):e0255055. doi: 10.1371/journal.pone.0255055. eCollection 2021. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five Self-harm Behaviour Groupings Measure (5S-HM)	Indirect and direct self-harm	Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Secondary	The World Health Organization Disability Assessment Schedule II (WHODAS 2)	Daily functioning and impairment	Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Secondary	The Borderline Symptom List-23 (BSL-23)	Borderline symptoms	Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Secondary	The Level of Personality Functioning Scale-Brief Form 2.0 (LPFS 2.0)	Personality functioning	Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Secondary	The Personality Inventory for DSM-V Brief Form (PID-5-BF)	Personality structure	Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Secondary	Hospitilization days	Days admitted to a psychiatric ward past year	Treatment at end of treatment and at follow up at 24 months.