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

NCT02200341 | Completed

• 2 other identifiers: 2014P000223K01AT008225
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• brain activation in regions of interest

  Brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: an interoceptive attention task and a rumination task.

  baseline and 8 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

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

Behavioral: MBCT

Progressive Relaxation Training - Psychoeducation

ACTIVE COMPARATOR

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

Behavioral: PRT-PsyEd

Interventions

MBCT BEHAVIORAL

Mindfulness-Based Cognitive Therapy (MBCT)

PRT-PsyEd BEHAVIORAL

Progressive Relaxation Training - Psychoeducation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gaelle Desbordes, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Radiology

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: August 1, 2015
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

US (1)