- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02457936
Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals
Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Cognitive Therapy for Depressed Individuals
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02129
- Massachusetts General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Based Cognitive Therapy (MBCT)
This group will receive 8 weeks of Mindfulness Based Cognitive Therapy
|
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
|
|
Active Comparator: Waiting list
This group will be tested twice 8-10 weeks apart and then receive 8 weeks of Mindfulness Based Cognitive Therapy
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale
Time Frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
|
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
Time Frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
|
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
Time Frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
|
Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Greenberg, PhD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P002481
- K23AT010653-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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