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

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Mass General Brigham

Status

Completed

Conditions

Depression

Treatments

Behavioral: PRT-PsyEd
Behavioral: MBCT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02200341
2014P000223
K01AT008225 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment

54 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy (MBCT)
Experimental group
Description:
Mindfulness-Based Cognitive Therapy (MBCT) 8-week intervention
Treatment:
Behavioral: MBCT
Progressive Relaxation Training - Psychoeducation
Active Comparator group
Description:
Progressive Relaxation Training and Psychoeducation (PRT-PsyEd) 8-week intervention
Treatment:
Behavioral: PRT-PsyEd

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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