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
  Purpose

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 Intervention Phase
Depression
Behavioral: Central Meditation and Imagery Therapy
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Central Meditation and Imagery Therapy for Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01671436

Locations
United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Felipe Jain, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Felipe Jain, MD, Health Sciences Instructor/Postdoctoral Scholar, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01671436     History of Changes
Other Study ID Numbers: CMIT-1042
Study First Received: August 20, 2012
Last Updated: March 30, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Depression
Guided Imagery
Psychotherapy
Meditation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014