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

February 27, 2024 updated by: Region Skane

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.

  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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden, 22185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Standard Dialectical Behaviour Therapy of up to 12 months as described Professor Linehan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Treatment start, 3,6,9 and at end of treatment and at follow up at 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Daily functioning and impairment
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.
Borderline symptoms
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.
Personality functioning
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.
Personality structure
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.
Days admitted to a psychiatric ward past year
Treatment at end of treatment and at follow up at 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

University of Toronto
Department of Psychology. Lund University.
Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2023-03990-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Possibly not aoolicable due to Swedish data protection law

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Borderline Personality Disorder

Clinical Trials on Dialectibal Behaviour Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe