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Clinical Trials/NCT06005129
NCT06005129CompletedNot Applicable

Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine

Shannon E. Sauer-Zavala1 site in 1 country39 target enrollmentStarted: September 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
39
Locations
1
Primary Endpoint
Change in clinician-rated borderline personality disorder symptoms

Study Overview

Brief Summary

Participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment. After the baseline period, participants will receive six weekly 50-60-minute treatment sessions. After the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Speak English fluently
  • Diagnosis of Borderline Personality Disorder

Exclusion Criteria

  • diagnosed psychological conditions that would be better addressed by alternative treatments
  • concurrent psychotherapy
  • medication instability
  • substance use disorder

Arms & Interventions

Personality-based treatment 2 week baseline

Experimental

Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment

Intervention: Personality-Based Therapy (Behavioral)

Personality-based treatment 4 week baseline

Experimental

Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment

Intervention: Personality-Based Therapy (Behavioral)

Outcomes

Primary Outcomes

Change in clinician-rated borderline personality disorder symptoms

Time Frame: up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)

Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - clinician-rated version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms

Change in patient-reported borderline personality disorder symptoms

Time Frame: weekly up to 14 weeks

Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - self-report version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shannon E. Sauer-Zavala
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Shannon E. Sauer-Zavala

Associate Professor

University of Kentucky

Study Sites (1)

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