Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Central Meditation and Imagery Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder
Eligibility 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
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
meditation
wait list
Arm Description
Central Meditation and Imagery Therapy
waiting list
Outcomes
Primary Outcome Measures
Borderline Symptoms
Borderline Symptom List
Secondary Outcome Measures
Depression
Quick Inventory of Depressive Symptoms
Anxiety
Trait Anxiety Inventory
Positive Affect
Positive and Negative Affect Scale
Full Information
NCT ID
NCT02125942
First Posted
April 26, 2014
Last Updated
January 11, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02125942
Brief Title
Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment
Official Title
Pilot Study of Central Meditation and Imagery Therapy for Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
meditation
Arm Type
Experimental
Arm Description
Central Meditation and Imagery Therapy
Arm Title
wait list
Arm Type
No Intervention
Arm Description
waiting list
Intervention Type
Behavioral
Intervention Name(s)
Central Meditation and Imagery Therapy
Intervention Description
mindfulness, guided imagery, meditation
Primary Outcome Measure Information:
Title
Borderline Symptoms
Description
Borderline Symptom List
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
Quick Inventory of Depressive Symptoms
Time Frame
6 weeks
Title
Anxiety
Description
Trait Anxiety Inventory
Time Frame
6 weeks
Title
Positive Affect
Description
Positive and Negative Affect Scale
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Heart rate variability
Description
Resting heart rate variability
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe A Jain, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
Learn more about this trial
Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment
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