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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02200341
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
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Study Details

Study Description

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 Phase
  • Behavioral: MBCT
  • Behavioral: PRT-PsyEd
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 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
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Dec 15, 2018
Actual Study Completion Date :
Dec 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness-Based Cognitive Therapy (MBCT)

Mindfulness-Based Cognitive Therapy (MBCT) 8-week intervention

Behavioral: MBCT

Active Comparator: Progressive Relaxation Training - Psychoeducation

Progressive Relaxation Training and Psychoeducation (PRT-PsyEd) 8-week intervention

Behavioral: PRT-PsyEd

Outcome Measures

Primary Outcome Measures

  1. brain activation in regions of interest [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
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:
  1. A score of 37 of higher on the Inventory of Depressive Symptomatology - Clinician version (IDS-C30).

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

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

  4. 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.

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

  6. 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).

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

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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).

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02129

Sponsors and Collaborators

  • Massachusetts General Hospital
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Gaelle Desbordes, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Desbordes, Gaelle, Instructor in Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02200341
Other Study ID Numbers:
  • 2014P000223
  • K01AT008225
First Posted:
Jul 25, 2014
Last Update Posted:
May 9, 2019
Last Verified:
May 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2019