NCT02465697

Brief Summary

Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has proven quite treatment resistant. This study is designed to determine whether patients with BPD can be trained to improve their ability to regulate their emotions and whether this leads to changes in how their brans regulate emotion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

6.1 years

First QC Date

June 4, 2015

Last Update Submit

October 27, 2017

Conditions

Borderline Personality DisordersAvoidant Personality Disorders

Keywords

Borderline Personality DisorderAvoidant Personality DisorderBrain Imaging

Outcome Measures

Primary Outcomes (2)

  • Changes in BOLD signal in brain

    BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity.

    baseline and 5 days

  • Changes in BOLD signal in brain

    BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.

    baseline and 2 weeks

Secondary Outcomes (4)

  • Perceived Stress Scale

    baseline and 5 days

  • Perceived Stress Scale

    baseline and 2 weeks

  • State Trait Anger Expression Inventory (STAXI)

    baseline and 5 days

  • State Trait Anger Expression Inventory (STAXI)

    baseline and 2 weeks

Study Arms (6)

BPD Emotion Regulation Training

EXPERIMENTAL

Guided practice in reappraisal

Behavioral: Reappraisal Training

BPD Control

NO INTERVENTION

no training in reappraisal

APD Emotion Regulation Training

EXPERIMENTAL

Guided practice in reappraisal

Behavioral: Reappraisal Training

APD Controls

NO INTERVENTION

no training in reappraisal

Healthy Controls Emotion Regulation Training

EXPERIMENTAL

Guided practice in reappraisal

Behavioral: Reappraisal Training

Healthy Controls

NO INTERVENTION

no training in reappraisal

Interventions

Reappraisal TrainingBEHAVIORAL
Also known as: Emotion Regulation Training
APD Emotion Regulation TrainingBPD Emotion Regulation TrainingHealthy Controls Emotion Regulation Training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BPD subjects 18 to 50 years old
  • Meet criteria for DSM-IV Borderline Personality Disorder, including the DSM-IV criteria for affective instability (criterion #6), and not meet criteria for Schizotypal Personality Disorder (SPD) or AvPD.
  • Subjects in the AvPD group meet DSM-IV criteria for AvPD and not for BPD or SPD.
  • All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
  • Subjects may be enrolled in psychotherapy

You may not qualify if:

  • BPD and AvPD subjects will not meet DSM-IV criteria for past or present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression.
  • Substance abuse disorder in the prior 6 months
  • Significant medical illness
  • Pregnancy
  • Metallic foreign-bodies that contraindicate MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Borderline Personality DisorderPersonality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Harold W Koenigsberg, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 8, 2015

Study Start

September 1, 2011

Primary Completion

September 21, 2017

Study Completion

September 21, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

US(1)