Benchmarking and Change Mechanisms in Personality Disorder Treatment

NCT06804369 | Active Not Recruiting

• 1 other identifier: S67356
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Personality disorders (PDs) are severe mental disorders characterized by pathological personality traits as well as problems in identity and interpersonal relationships (American Psychiatric Association, 2013). Several effective psychotherapies for PDs have been developed in the past decades, however, two important questions regarding PD treatment have not been sufficiently addressed: (1) how effective are PD treatments outside of the controlled settings of randomized controlled trials (RCTs); (2) are the effects of PDT clinically meaningful; and (3) what are the core processes that produce change in PD treatment? The present observational study aims to address these research gaps by (1) comparing the effects of intensive psychodynamic therapy (PDT) for PDs in a naturalistic setting to benchmarks found in RCTs; (2) analyzing which proportion of patients achieves clinically meaningful change and (3) investigating whether outcomes in intensive PDT are associated with a number of theoretically expected mechanisms of change.

Conditions

Personality Disorders

Keywords

personality disorders; change mechanisms; benchmarking; epistemic trust; mentalizing; resilience; psychodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Changes in General Psychological Symptoms

  Self-reported severity of general psychological symptoms as assessed using the Brief Symptom Inventory (BSI; Derogatis \& Melisaratos, 1983).

  From baseline to treatment termination (on average 9 months after the start of treatment)

Secondary Outcomes (7)

• Changes in Borderline Personality Disorder Symptom Severity

  From baseline to treatment termination (on average 9 months after the start of treatment), and at 6-month, and one- and two-year follow-up

• Changes in General Psychological Symptoms

  From baseline to 6-month, and one- and two-year follow-up

• Changes in Personality Functioning

  From baseline to treatment termination (on average 9 months after the start of treatment), and 6-month, and one- and two-year follow-up

• Changes in Interpersonal Problems

  From baseline to treatment termination (on average 9 months after the start of treatment), and 6-month, and one- and two-year follow-up

• Changes in Symptoms of Post-traumatic Stress

  From baseline to treatment termination (on average 9 months after the start of treatment), and 6-month, and one- and two-year follow-up

Other Outcomes (1)

• Change Mechanisms

  At baseline, after 3 months of treatment, 6 months of treatment and at treatment termination (on average 9 months after the start of treatment)

Study Arms (1)

Personality Disorder Patients

All patients consecutively admitted to the KLIPP treatment unit (UPC KU Leuven, Belgium) until the target sample size (N = 110) is reached. All patients have been referred to this specialized treatment because of prominent personality disorder pathology and undergo multidisciplinary assessment by a psychiatrist, clinical psychologist and social worker.

Behavioral: Intensive psychodynamic therapy (PDT)

Interventions

Intensive psychodynamic therapy (PDT) BEHAVIORAL

The KLIPP treatment unit (UPC KU Leuven, campus Kortenberg) provides intensive psychodynamic treatment (PDT) for patients with different types of PDs. There are three different programs that differ in treatment intensity: (1) inpatient treatment program (5 days a week), (2) day treatment program (4 days a week), and (3) a part-time outpatient treatment program of two half days per week. Patients attend one of these programs and stay in the program for at least 6 months (with an average duration of 8 months). The programs include individual and group psychodynamic psychotherapy as well as art, music and psychomotor therapy.

Also known as: Psychodynamic Psychotherapy

Personality Disorder Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be consecutively admitted patients to the Klipp treatment unit at the University Psychiatric Center (UPC) KU Leuven, Campus Kortenberg (Belgium) which provides specialized treatment for PDs, starting from April 17 2023 until the target sample size of N = 110 is reached.

You may qualify if:

• Individuals (male, female, non-binary or other) older than 18 years
• Meeting criteria for personality disorder as assessed by a psychiatrist and confirmed with the PID-5 and LFPS self-report scales
• Sufficient mastery of the Dutch language to follow treatment and complete questionnaires
• Agreeing to participate in the study following informed consent procedure

You may not qualify if:

• Substance abuse that would interfere with the ability to adhere to the treatment
• Acute psychotic symptoms as assessed by a psychiatrist

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Psychiatric Center KU Leuven

Kortenberg, Vlaams-Brabant, 3070, Belgium

Location

MeSH Terms

Conditions

Personality Disorders

Interventions

Psychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Celine De Meulemeester, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 3, 2025
• Study Start: April 17, 2023
• Primary Completion: April 17, 2026
• Study Completion (Estimated): April 17, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After publication of the study's main results.
• Access Criteria: Requests can be made by other researchers by contacting the corresponding author of the study publications via e-mail. The requests will be evaluated by the Prinicipal Investigator. IPD will be made available for meta-analyses or other follow-up studies. De-identified data will be shared via the secure data transfer application Send-it in REDCAP. The recipient will receive an email containing a unique download URL, along with a second follow-up email with the password (for greater security) for downloading the file. The file will be stored securely and then later removed from the server after the specified expiration date.

Locations

BE (1)