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Completed

NCT Number: NCT02457936

Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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