Overview

This trial is active, not recruiting.

Condition depression
Treatment mindfulness based cognitive therapy
Sponsor Massachusetts General Hospital
Collaborator AlterMed Research foundation
Start date April 2015
End date April 2016
Trial size 52 participants
Trial identifier NCT02457936, 2014P002481

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This group will receive 8 weeks of Mindfulness Based Cognitive Therapy
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)
This group will be tested twice 8-10 weeks apart and then receive 8 weeks of Mindfulness Based Cognitive Therapy
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

Primary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Cognitive Therapy for Depressed Individuals
Principal investigator Jonathan Greenberg, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.