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Trial record 3 of 8 for:    Completed | guided imagery | United States, California

Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Jain, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02125942
First received: April 26, 2014
Last updated: March 24, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Borderline Personality Disorder
Behavioral: Central Meditation and Imagery Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Central Meditation and Imagery Therapy for Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Borderline Symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Borderline Symptom List


Secondary Outcome Measures:
  • Depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptoms

  • Anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Trait Anxiety Inventory

  • Positive Affect [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Positive and Negative Affect Scale


Other Outcome Measures:
  • Heart rate variability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Resting heart rate variability


Enrollment: 15
Study Start Date: April 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: meditation
Central Meditation and Imagery Therapy
Behavioral: Central Meditation and Imagery Therapy
mindfulness, guided imagery, meditation
No Intervention: wait list
waiting list

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active suicidality or suicidal intent as identified on the Columbia Suicide Severity Rating Scale
  • Suicide attempt within the past month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125942

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Felipe A Jain, MD University of California, Los Angeles
  More Information

Responsible Party: Felipe Jain, MD, Clinical Instructor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02125942     History of Changes
Other Study ID Numbers: CMIT1044 
Study First Received: April 26, 2014
Last Updated: March 24, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Borderline Personality Disorder

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016