- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06880640
Affect-based Impulsivity in Borderline Personality Disorder
Affect-based Impulsivity in Borderline Personality Disorder: Developing a Neurocomputational Phenotype
The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.
Participants will complete online behavioral tasks, a stress induction procedure, self-report surveys, and a cognitive assessment. During the session, psychophysiological measures will be collected, including electrocardiogram (ECG) and cardiac impedance (ICG) to monitor heart rate and blood flow, as well as electrodermal activity (EDA), blood drop samples, and saliva collection to assess nervous system activity.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael N Hallquist, PhD
- Phone Number: 412-613-9306
- Email: michael.hallquist@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- University of North Carolina at Chapel Hill
-
Contact:
- Michael N Hallquist, PhD
- Phone Number: 412-613-9306
- Email: michael.hallquist@unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Borderline Personality Disorder (BPD) group:
- Score of 38 or higher on Personality Assessment Inventory-Borderline Scale (PAI-BOR)
- Participants in the BPD group will be primarily recruited from the two
DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the current study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:
- 3+ BPD symptoms, one of which must be affective instability, per clinical interview
- Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).
Health Control (HC) Group:
- Score of 12 or lower on PAI-BOR
- Score below 50th percentile on World Health Organization Disability Assessment Schedule (WHODAS)
- Absence of any current or lifetime psychiatric disorder, including personality disorders as determined by diagnostic interviews (SIDP and SCID), if the participant had participated in the lab's other studies (IRB Nos. 20-1735 and 21-0602).
Combined Inclusion Criteria:
- Ages 18-45
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to participate in all components of the study
- Participants must be able to speak, understand and read English.
- Participants must have at least 20/40 visual acuity (correct or uncorrected).
Exclusion Criteria:
- Use of as needed antihypertensive agents within 12 hours prior to lab visit
- Inability to refrain from using as needed psychotropic medications for 12 hours prior to lab visit
- History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence
- Family history of Bipolar I disorder in a first degree relative.
- Participants are also excluded for any of the following: cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress
Participants will undergo a controlled stress induction approximately 1 hour and 35 minutes into Session 1.
|
Participants will complete the Trier Social Stress Test to induce stress, which includes a public speaking simulation and mental arithmetic.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal-directed decision-making in the Social Decision Tree Task (SDTT)
Time Frame: Collected for 40 minutes ~2 hours into one-time study visit
|
Measured by choice behavior in SDTT, which is based on the decision tree framework. After each action, participants receive feedback about the effect of that action and the extent to which it added to or took away from their points. If participants make a given choice, the subsequent actions that they can choose are different than if they were to initially make a different choice. An action in SDTT is goal-directed if the possible net gain an individual can earn before the end of the current epoch (a "day" in the SDTT) is equal to or higher than the amount they could gain by choosing the alternative action. The investigators will subset trials so that 1 is coded as choosing the immediately valuable action at the expense of the optimal and 0 is coded as choosing the optimal at the expense of the immediately valuable action. This outcome variable is binary. |
Collected for 40 minutes ~2 hours into one-time study visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bias toward social actions in the Social Decision Tree Task (SDTT)
Time Frame: Collected for 40 minutes ~2 hours into one-time study visit
|
Measured by choice behavior in SDTT, which is based on the decision tree framework.
An action in SDTT is defined as social if it is paired with a visual cue with a face on it and non-social if not.
This outcome variable is binary.
|
Collected for 40 minutes ~2 hours into one-time study visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in salivary cortisol
Time Frame: Collected shortly after the participant consents into the study (~20 minutes into the one-time study visit) and 20 minutes after stress induction concludes (~2 hours into one-time study visit)
|
The investigators will collect a saliva sample to measure baseline salivary cortisol at the beginning of the session.
They will collect a second saliva sample 10 minutes after the stress induction concludes.
They will measure cortisol levels in both samples through an assay.
The investigators will calculate the change in salivary cortisol by subtracting the measured cortisol in the first saliva sample (collected at baseline) from the measured cortisol in the second saliva sample (collected 10 minutes after the stress induction).
Salivary cortisol is measured as nmol/L.
Salivary cortisol expected to generally be below 200 nmol/L.
|
Collected shortly after the participant consents into the study (~20 minutes into the one-time study visit) and 20 minutes after stress induction concludes (~2 hours into one-time study visit)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Hallquist, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-3120
- CTSC0406 (Other Grant/Funding Number: The North Carolina Translational and Clinical Sciences (TraCS) Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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