NCT06106555

Brief 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. 1.Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?
  2. 2.Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?
  3. 3.Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?
  4. 4.When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2023Aug 2027

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

October 24, 2023

Last Update Submit

June 24, 2025

Conditions

Keywords

Borderline Personality DisorderDialectical Behavior TherapyDeliberate Self-HarmNon-suicidal Self-injurySelf-conceptPersonality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The World Health Organization Disability Assessment Schedule II (WHODAS 2)

    Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.

  • The Borderline Symptom List-23 (BSL-23)

    Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.

  • The Level of Personality Functioning Scale-Brief Form 2.0 (LPFS 2.0)

    Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.

  • The Personality Inventory for DSM-V Brief Form (PID-5-BF)

    Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.

  • Hospitilization days

    Treatment at end of treatment and at follow up at 24 months.

Study Arms (1)

Individuals with BPD

Individuals with BPD, as defined by the DSM-V, and a recent history (past 12 months) of self-harming behaviour.

Behavioral: Dialectibal Behaviour Therapy

Interventions

Standard Dialectical Behaviour Therapy of up to 12 months as described Professor Linehan

Individuals with BPD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with Borderline personality disorder in a specialized psychiatric setting. A majority of the individuals will have comorbid psychiatric conditions and have been offered other pharmacological and psychological treatments through their GP or a general psychiatric outpatient unit prior to the study intervention. Other treatments are permitted for inclusion in this study.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to read or communicate in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund adult psychiatric hospital

Lund, Skåne County, 22185, Sweden

RECRUITING

Related 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.

    PMID: 30599336BACKGROUND
  • 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.

    PMID: 17544636BACKGROUND
  • 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.

    PMID: 34519138BACKGROUND
  • 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.

    PMID: 29167651BACKGROUND
  • 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.

    PMID: 30447724BACKGROUND
  • 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.

    PMID: 30469092BACKGROUND
  • 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.

    PMID: 25557395BACKGROUND
  • 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.

    PMID: 30230242BACKGROUND
  • 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.

    PMID: 32932110BACKGROUND
  • 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.

    PMID: 22153017BACKGROUND
  • 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.

    PMID: 23727659BACKGROUND
  • 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.

    PMID: 32979766BACKGROUND
  • 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.

    PMID: 28910214BACKGROUND
  • 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.

    PMID: 28249032BACKGROUND
  • 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.

    PMID: 31414575BACKGROUND
  • 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.

    PMID: 7199382BACKGROUND
  • 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.

    PMID: 34314461BACKGROUND

MeSH Terms

Conditions

Borderline Personality DisorderSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Magnus Nilsson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations