Meditation for Depression (CMIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Jain, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01671436
First received: August 20, 2012
Last updated: March 30, 2014
Last verified: March 2014

August 20, 2012
March 30, 2014
September 2012
November 2013   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Measured 4 times over 12 weeks ] [ Designated as safety issue: No ]
Primary outcome is change in HAM-D from baseline to Week 12.
Same as current
Complete list of historical versions of study NCT01671436 on ClinicalTrials.gov Archive Site
Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR) [ Time Frame: Weekly assessments measured over 12 weeks, and 2 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Meditation for Depression
Central Meditation and Imagery Therapy for Depression

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.

Not Provided
Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
Behavioral: Central Meditation and Imagery Therapy
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.
Intervention: Behavioral: Central Meditation and Imagery Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
March 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meeting the DSM-IV criteria for unipolar major depressive disorder, as assessed by the Mini-Neuropsychiatric International Interview (MINI).
  • HAM-D17 rating scale ≥ 14.
  • Prior treatment with antidepressant medication during the present major depressive episode
  • Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
  • Willingness on part of both subject and treating clinician to not change antidepressant treatment, including medications, psychotherapy or other treatments, over the course of the study, unless necessary to provide for well being of subject.

Exclusion Criteria:

  • Current diagnosis of schizophrenia or any psychotic disorder including psychotic depression, dysthymia, mania or bipolar disorder, attention deficit or hyperactivity disorder, generalized anxiety disorder or panic disorder, obsessive compulsive disorder, alcohol or drug dependence, mental retardation, any pervasive developmental disorder or cognitive disorder (according to DSM-IV) criteria. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
  • Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; congestive heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; or pending surgery).
  • Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
  • Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.
  • Current treatment with behavior therapy or psychotherapy.
  • Active suicidal plan as measured by HAM-D item 3 score of greater than or equal to 3, or history of suicide attempt during the current episode.
  • Utilization of cannabis or other illicit drugs more than once a month.
  • Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7 standard drinks per week or 3 drinks per day.
  • Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671436
CMIT-1042
Yes
Felipe Jain, MD, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Felipe Jain, M.D. University of California, Los Angeles
University of California, Los Angeles
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP