Clinical trial NCT02457936: Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals
Official title: Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Cognitive Therapy for Depressed Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-05-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale
timeFrame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
measure: Change from baseline in cognitive flexibility, as measured by a computer task involving task-switching and by the Torrance Test for Creative Thinking
timeFrame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
measure: Change from baseline in attention regulation, as measured by the Attention Network Test
timeFrame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan Greenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: