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Clinical Trials/NCT06106555
NCT06106555
Recruiting
Not Applicable

Vilka Faktorer påverkar Behandlingsutfall Vid Dialektisk Beteendeterapi för Borderline Personlighetssyndrom?

Region Skane1 site in 1 country100 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Region Skane
Enrollment
100
Locations
1
Primary Endpoint
Five Self-harm Behaviour Groupings Measure (5S-HM)
Status
Recruiting
Last Updated
10 months ago

Overview

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. 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?

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
August 31, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 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.)
  • 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 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.)

Study Sites (1)

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