Meditation for Depression (CMIT)
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|ClinicalTrials.gov Identifier: NCT01671436|
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 12, 2017
Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However, currently available treatment options have limited efficacy. The aim of this pilot study is to determine whether patients suffering from MDD who have not responded to at least one antidepressant trial may actively engage in a novel group therapy, Central Meditation and Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT techniques may have benefit for major depression. The purpose of this trial is to assess the feasibility of a group form of CMIT for the treatment of major depression. The trial will also seek to identify neurophysiological and cardiovascular predictors of treatment response.
In this study, 10 subjects with major depressive disorder will receive antidepressant treatment augmentation with group meditation and mental imagery therapy for a total of 12 weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic stretches. The subjects will be limited to those who remain depressed despite at least one trial of antidepressant medication. Changes in brain activity and heart rate variability will be measured at three time points utilizing electroencephalography (EEG) and pulse monitors. Depression symptoms will be measured at several time points using questionnaires and objective measures. Participation will require a total of 15 visits for weekly therapy and the measurements. Two-month follow-up questionnaires will be mailed to the subjects after study end to assess durability of any improvements in depressive symptoms.
|Condition or disease||Intervention/treatment|
|Depression||Behavioral: Central Meditation and Imagery Therapy|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Central Meditation and Imagery Therapy for Depression|
|Study Start Date :||September 2012|
|Primary Completion Date :||November 2013|
|Study Completion Date :||March 2014|
Experimental: Central Meditation and Imagery Therapy
Intervention involved Central Meditation, may be characterized by a voluntary, regulated attentional set towards a specific stimulus or set of stimuli and visualization exercises utilized within CMIT, which primarily involves two types of thought experiments: 1) creating mental models of how a person fits into the larger world and universe according to evolutionary biology and modern cosmology, in order to gain a larger perspective on emotions and thought patterns, and 2) backcasting, the generation of a desirable future coupled with mental time travel back to the present to determine how to create that future with present-day actions.
|Behavioral: Central Meditation and Imagery Therapy|
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Measured 4 times over 12 weeks ]Primary outcome is change in HAM-D from baseline to Week 12.
- Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR) [ Time Frame: Weekly assessments measured over 12 weeks, and 2 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671436
|United States, California|
|UCLA Semel Institute|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Felipe Jain, M.D.||University of California, Los Angeles|