NCT07639957

Brief Summary

This study is a mixed-methods, single-arm cross-sectional study comprising 1) a qualitative, exploratory, critical-constructivist content analysis examining the significance of gender in relationship experiences and self-perception among individuals with borderline personality disorder and various gender identities, and 2) a pilot study on the use of the Single-Category Implicit Association Test (SC-IATs, adapted from von Hippel et al., 2018) as preparation for a larger-scale experimental psychological study using the SC-IAT to assess implicit gender- and BPD-related thought processes in people with borderline personality disorder and various gender identities. 15 individuals with BPD and different gender identities will be assessed. The research questions are:

  1. 1.What gender-related relationship- and self-experiences can be identified in people with BPD? How do experiences relate to observer-coded and self-reported mentalization ability, as well as self-reported symptoms, experiences of stigmatization, and quality of life?
  2. 2.Is there preliminary evidence that Single-Category Implicit Association Tests (SC-IATs) are suitable and reliable instruments for measuring implicit gender- and BPD-related thought processes in people with BPD?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

May 22, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

Borderline Personality DisorderGenderGrounded TheoryImplicit Association Test

Outcome Measures

Primary Outcomes (5)

  • Role of Gender in BPD

    Categories and themes derived from Grounded Theory qualitative content analysis of semi-structured interviews with individuals diagnosed with BPD, capturing experiences of gender in relation to self and interpersonal relationships including structural power dynamics

    At baseline

  • SC-IAT score

    D-score derived from SC-IAT reaction times (ratio of mean reaction times between experimental blocks), reflecting the strength of implicit associations.

    At baseline

  • SC-IAT Stimulus Accuracy

    Proportion of correct responses per stimulus and proportion of correct responses across all trials.

    At baseline

  • SC-IAT Internal Consistency

    Internal consistency of each SC-IAT, assessed via split-half reliability or comparable coefficient.

    At baseline

  • Intercorrelation of SC-IAT D-Scores

    Correlation coefficients between D-scores across SC-IAT versions, assessed as indicator of multicollinearity.

    At baseline

Secondary Outcomes (7)

  • Correlations Between Qualitative Category Frequencies and Psychosocial Construct Scores

    At baseline

  • SC-IAT Administration Duration

    At baseline

  • SC-IAT Convergent Validity

    At baseline

  • SC-IAT Participant Acceptance

    At baseline

  • Exploratory Correlations Between SC-IAT D-Scores and Psychosocial Construct Scores

    At baseline

  • +2 more secondary outcomes

Other Outcomes (13)

  • Mentalization Questionnaire

    At baseline

  • Mentalizing Gender Experience Questionnaire

    At baseline

  • Certainty of Mental States Questionnaire

    At baseline

  • +10 more other outcomes

Study Arms (1)

Individuals with BPD and different gender identities

Equal distribution of cis female, cis male and trans\* and/or gender nonconforming individuals is aimed for

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsall, however, recruitment will be theoratically sampled so that different gender identity groups are equally represented (cis female, TGNC, cis male)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The majority of recruitment takes place among participants in the study "Mentalization-based treatment versus bona-fide treatment for patients with Borderline Personality Disorder in Germany (MAGNET): a prospective, multi-center randomized controlled trial" (S-493/2023). Only those participants who indicated in the MAGNET study consent form that they consent to being contacted for further studies and have not withdrawn this consent will be contacted. In addition, individuals with diverse gender identities may be recruited through the Institute for Psychosocial Prevention and Psychotherapy at Heidelberg University Hospital using flyers (posted at the institute, on the website, and distributed during initial consultations)

You may qualify if:

  • Signed informed consent form
  • Individuals of all genders (target: n=5 with female gender identity, n=5 with nonbinary/trans\*/gender-non-conforming (TGNC) gender identity, n=5 with male gender identity) between the ages of 18 and 65 at the time of consent
  • Individuals with a BPD diagnosis made within the last 2 years (ICD-10: F60.3; DSM-5: 301.83, ICD-11: Borderline qualifier)
  • Understanding of the study procedure, ability and willingness to participate
  • The participant is able to read and understand the informed consent form and can provide a written, personally signed, and dated informed consent form.

You may not qualify if:

  • Acute suicidal ideation or acute psychotic symptoms reported by the patient or suspected
  • Insufficient language skills (i.e., knowledge of German or English)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Psychosocial Prevention and Psychotherapy, University Hospital Heidelberg

Heidelberg, 69115, Germany

RECRUITING

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Related Links

MeSH Terms

Conditions

Borderline Personality DisorderCoitus

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSexual BehaviorBehavior

Study Officials

  • Sophie Hauschild, Dr.

    Institute for Psychosocial Prevention and Psychotherapy, University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil. Sophie Hauschild

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 10, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Anonymized aggregated data from the computer tasks and questionnaire surveys will be uploaded to OSF. Pseudonymized data will be provided to other researchers exclusively upon plausible, verified request for the purpose of ensuring transparency in scientific research. Data from the interviews are not shared with third parties.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations