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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02125942
Other study ID # CMIT1044
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date September 2015

Study information

Verified date January 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Central Meditation and Imagery Therapy
mindfulness, guided imagery, meditation

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate variability Resting heart rate variability 6 weeks
Primary Borderline Symptoms Borderline Symptom List 6 weeks
Secondary Depression Quick Inventory of Depressive Symptoms 6 weeks
Secondary Anxiety Trait Anxiety Inventory 6 weeks
Secondary Positive Affect Positive and Negative Affect Scale 6 weeks
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