Borderline Personality DisorderNCT06106555
Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?
An observational study of Borderline Personality Disorder and Non-suicidal Self-injury, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder, Non-suicidal Self-injury, Deliberate Self Harm
- What is being tested?
- Dialectibal Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unable to read or communicate in Swedish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Lund adult psychiatric hospital
Lund, Skåne County, 22185
Magnus Nilsson, PhD, 046174925, magnus.per.nilsson@skane.se
About this study
Official title: Vilka Faktorer påverkar Behandlingsutfall Vid Dialektisk Beteendeterapi för Borderline Personlighetssyndrom?
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.
- Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?
- Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?
- Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?
- When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?
Read the detailed 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.
- Being tested
- Dialectibal Behaviour Therapy
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy, Deliberate Self-Harm, Non-suicidal Self-injury, Self-concept, Personality
- Medical subject headings
- Borderline Personality Disorder, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectibal Behaviour TherapyBehavioural
Standard Dialectical Behaviour Therapy of up to 12 months as described Professor Linehan
| Study group | Role | What they receive |
|---|---|---|
| Individuals with BPD | Individuals with BPD, as defined by the DSM-V, and a recent history (past 12 months) of self-harming behaviour. Receives: Behavioral: Dialectibal Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five Self-harm Behaviour Groupings Measure (5S-HM)
Indirect and direct self-harm
Measured: 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)
Daily functioning and impairment
Measured: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
The Borderline Symptom List-23 (BSL-23)
Borderline symptoms
Measured: 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)
Personality functioning
Measured: 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)
Personality structure
Measured: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Hospitilization days
Days admitted to a psychiatric ward past year
Measured: Treatment at end of treatment and at follow up at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Psychology. Lund University., University of Toronto, Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106555
- Sponsor's protocol ID
- Dnr 2023-03990-01
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possibly not aoolicable due to Swedish data protection law
Publications
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.
PubMed 30599336van 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.
PubMed 17544636Chen 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.
PubMed 34519138Cipriano 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.
PubMed 29167651Ellison 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.
PubMed 30447724Gad 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.
PubMed 30469092Gratz 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.
PubMed 25557395Weekers 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.
PubMed 30230242Kaufman 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.
PubMed 32932110Krueger 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.
PubMed 22153017Kroger 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.
PubMed 23727659Mehlum 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.
PubMed 32979766McMain 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.
PubMed 28910214Meuldijk 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.
PubMed 28249032Schmitgen 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.
PubMed 31414575
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vilka Faktorer påverkar Behandlingsutfall Vid Dialektisk Beteendeterapi för Borderline Personlighetssyndrom?
- ClinicalTrials.gov ID
- NCT06106555
- Acronym / sponsor ID
- Dnr 2023-03990-01
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy, Deliberate Self-Harm, Non-suicidal Self-injury, Self-concept, Personality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Department of Psychology. Lund University., University of Toronto, Lund University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?
- Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?
- Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?
- When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with BPD | – | Behavioral: Dialectibal Behaviour TherapyIndividuals with BPD, as defined by the DSM-V, and a recent history (past 12 months) of self-harming behaviour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to read or communicate in Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectibal Behaviour TherapyStandard Dialectical Behaviour Therapy of up to 12 months as described Professor Linehan | Behavioural | Individuals with BPD |
Primary outcome
Five Self-harm Behaviour Groupings Measure (5S-HM)
Time frame: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Indirect and direct self-harm
5 secondary outcomes
The World Health Organization Disability Assessment Schedule II (WHODAS 2)
Time frame: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
The Borderline Symptom List-23 (BSL-23)
Time frame: 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)
Time frame: 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)
Time frame: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.
Hospitilization days
Time frame: Treatment at end of treatment and at follow up at 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 30599336Alvarez-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.
- Background: PubMed 17544636van 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.
- Background: PubMed 34519138Chen 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.
- Background: PubMed 29167651Cipriano 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.
- Background: PubMed 30447724Ellison 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.
- Background: PubMed 30469092Gad 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.
- Background: PubMed 25557395Gratz 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.
- Background: PubMed 30230242Weekers 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.
- Background: PubMed 32932110Kaufman 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.
- Background: PubMed 22153017Krueger 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.
- Background: PubMed 23727659Kroger 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.
- Background: PubMed 32979766Mehlum 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.
- Individual participant dataSharing planned: Undecided. Possibly not aoolicable due to Swedish data protection law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder and Non-suicidal Self-injury, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Nilsson, PhD (046174925, magnus.per.nilsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Self-harm Behaviour Groupings Measure (5S-HM) (time frame: Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106555, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.