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

NCT ID: NCT02200341

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-Based Cognitive Therapy (MBCT)

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

Group Type: EXPERIMENTAL

MBCT

Intervention Type: BEHAVIORAL

Progressive Relaxation Training - Psychoeducation

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

Group Type: ACTIVE_COMPARATOR

PRT-PsyEd

Intervention Type: BEHAVIORAL

Interventions

MBCT

Intervention Type: BEHAVIORAL

PRT-PsyEd

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Desbordes, Gaelle

Instructor in Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaelle Desbordes, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

K01AT008225

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014P000223

Identifier Type: -

Identifier Source: org_study_id