Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals

NCT02457936 | Completed DMC

• 2 other identifiers: 2014P002481K23AT010653-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Depression one of the leading causes of disability worldwide. Individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly referred to as "cognitive flexibility"). Mindfulness meditation training is a technique which involves focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. It has been well documented to improve depressive symptoms and prevent recurrence of depressive episodes, yet little is known about how mindfulness does so and what are the underlying mental mechanisms involved. Here the investigators propose to examine the efficacy of an 8-week mindfulness training program in improving the ability to direct and control attention, as well as in cognitive flexibility. Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training program. Participants' depressive symptoms as well as their performance on measures of attention and cognitive flexibility will be examined. Participants will be assigned to mindfulness training or a wait-list control group. Half of the participants will be examined before and after the mindfulness training program and the other half will be tested 8-weeks apart and then begin their training.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale

  Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program

• Change from baseline in cognitive flexibility, as measured by a computer task involving task-switching and by the Torrance Test for Creative Thinking

  Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program

• Change from baseline in attention regulation, as measured by the Attention Network Test

  Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program

Study Arms (2)

Mindfulness Based Cognitive Therapy (MBCT)

EXPERIMENTAL

This group will receive 8 weeks of Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy

Waiting list

ACTIVE COMPARATOR

This group will be tested twice 8-10 weeks apart and then receive 8 weeks of Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

8 weekly meetings in which basic mindfulness and meditation skills are taught, such as breathing meditation, body scan meditation, open awareness meditation, movement meditation, and targeting depression related cognitions and emotions in a mindful manner, as well as awareness exercises, group discussions, and daily home meditation practice routines

Mindfulness Based Cognitive Therapy (MBCT); Waiting list

Eligibility Criteria

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

You may qualify if:

• Reporting dysphoria for at least two months prior
• HAM-D score of at least 11
• No history of psychiatric disorders of psychotic features, neurological disorders, or substance abuse in the past 6 months
• Verified age between 18-65 years old
• Had no suicidal attempts during the past six months
• No prior experience with MBCT or other systematic meditation programs

You may not qualify if:

• History of psychosis, neurological disorder, and substance abuse for the past 6 months
• Suicide attempt in past 6 months
• Prior experience with MBCT or other systematic meditation program

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

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jonathan Greenberg, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral research fellow

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 29, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 20, 2024

Record last verified: 2017-03

Locations

US (1)