NCT02125942

Brief Summary

Borderline personality disorder is a severe psychiatric disorder marked by emotional instability, difficulty with interpersonal relationships, and self-harming behaviors. Despite receiving psychotherapy for borderline personality disorder, studies show that patient recovery is slow, and there is a high rate of self injury and suicide attempts early in treatment. There is thus a clear need to provide therapies to augment psychotherapy. We will conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery Therapy (CMIT) is feasible for subjects with borderline personality disorder to undergo when added on to psychotherapy treatment. CMIT is a non-validated therapy that combines principles of mindfulness with meditation techniques and guided imagery. Sessions led by a trained clinician in a group setting once a week, and participants are asked to complete daily home practice. The trial will involve 16 participants, all currently undergoing psychotherapy for borderline personality disorder. Participants will be randomly assigned to either a CMIT group that lasts 6 weeks, or a wait list group. Those in the wait list group will be able to receive CMIT after 6 weeks. All participants will continue to receive psychotherapy throughout the trial. During the trial, we will also obtain preliminary data to help understand whether CMIT may result in psychological benefits for participants. This will include measuring the pulse in order to determine variation in beat to beat intervals of the heart during psychological tests, and filling out questionnaires before and after participation in CMIT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

April 26, 2014

Last Update Submit

January 11, 2021

Conditions

Keywords

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Borderline Symptoms

    Borderline Symptom List

    6 weeks

Secondary Outcomes (3)

  • Depression

    6 weeks

  • Anxiety

    6 weeks

  • Positive Affect

    6 weeks

Other Outcomes (1)

  • Heart rate variability

    6 weeks

Study Arms (2)

meditation

EXPERIMENTAL

Central Meditation and Imagery Therapy

Behavioral: Central Meditation and Imagery Therapy

wait list

NO INTERVENTION

waiting list

Interventions

mindfulness, guided imagery, meditation

meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meeting the diagnostic criteria for BPD according to DSM-IV criteria
  • Meeting the diagnostic criteria for BPD based on the Diagnostic Interview for Borderline - Revised
  • Currently receiving psychotherapy.
  • English language proficiency to understand written and oral communication

You may not qualify if:

  • Active suicidality or suicidal intent as identified on the Columbia Suicide Severity Rating Scale
  • Suicide attempt within the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Felipe A Jain, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2014

First Posted

April 29, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations