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Effects of Mindfulness-based Cognitive Therapy on Brain Mechanisms in Depression

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ClinicalTrials.gov Identifier: NCT02200341
Recruitment Status : Recruiting
First Posted : July 25, 2014
Last Update Posted : March 28, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Desbordes, Gaelle, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in individuals suffering from major depressive disorder (MDD).

Condition or disease Intervention/treatment
Depression Behavioral: MBCT Behavioral: PRT-PsyEd

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: MBCT Effects on Brain Mechanisms of Interoceptive Awareness and Rumination in MDD
Study Start Date : August 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MBCT
Mindfulness-Based Cognitive Therapy 8-week intervention
Behavioral: MBCT
Active Comparator: PRT-PsyEd
Progressive Relaxation Training and Psychoeducation 8-week intervention
Behavioral: PRT-PsyEd

Primary Outcome Measures :
  1. brain activation in regions of interest [ Time Frame: baseline and 8 weeks ]
    Brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: an interoceptive attention task and a rumination task.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • current mild-to-moderate depression symptoms (score 12-36 on IDS-C30)
  • history of at least 3 depressive episodes or history of 2 years of depression symptoms
  • on either no pharmacological treatment or on maintenance antidepressant treatment for at least 8 weeks before the start of the intervention
  • English literacy
  • normal or near-normal vision

Exclusion Criteria:

i. A score of 37 of higher on the Inventory of Depressive Symptomatology - Clinician version (IDS-C30).

ii. Significant risk for suicide, defined by a score of 3 on Item 18 in the IDS-C30, or as assessed by evaluating clinician.

iii. Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.

iv. The following DSM disorders: any bipolar disorder (current or past), a primary psychotic disorder (current or past), or current psychotic symptoms. However, entry of patients with anxiety disorder(s) will be permitted if the depressive disorder is judged to be the predominant disorder.

v. Active diagnosis of substance abuse or dependence disorders within the last 3 months.

vi. General conditions that would impede participation in a group intervention, as assessed by the evaluating clinician or the therapist delivering the MBCT intervention (such as severe characterological disorders, cognitive impairment, tendencies toward physical aggression).

vii. Past or current training in mindfulness (MBCT, Mindfulness-Based Stress Reduction) or in the Relaxation Response.

viii. Significant training in meditation (or related practices), i.e., more than 10 meditation classes in the past 3 months, or more than 10 classes in yoga, Tai Chi, or Qi Gong in the past 3 months.

ix. Currently taking any psychoactive drugs (whether prescription, over-the-counter, or recreational) other than prescribed antidepressants. This restriction includes the following supplements: Hypericum perforatum (St. John's wort), Valeriana officinalis (valerian), and 5-Hydroxytryptophan (5-HTP).

x. Any change in type or dosage of treatment (whether with antidepressant medication or with psychotherapy or psychosocial intervention) in the 8 weeks preceding the start of the intervention.

xi. Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., Meniere's disease, epilepsy, claustrophobia, currently pregnant or breastfeeding or planning to conceive or breastfeed during the study, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.

xii. A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).

xiii. Unable or unwilling to fill in online questionnaires or to be contacted over the phone by study staff for periodic assessments.

Information from the National Library of Medicine

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): NCT02200341

Contact: Gaelle Desbordes, PhD 617-643-2467 gdesbord@nmr.mgh.harvard.edu

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Gaelle Desbordes, PhD    617-643-2467    gdesbord@nmr.mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Gaelle Desbordes, PhD Massachusetts General Hospital

Responsible Party: Desbordes, Gaelle, Instructor in Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02200341     History of Changes
Other Study ID Numbers: 2014P000223
K01AT008225 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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