Clinical Trial: Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

Brief Summary: The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.

Detailed Summary: We propose a prospective, randomized controlled pilot trial assessing the feasibility and safety of a study investigating mindfulness based stress reduction (MBSR) as an intervention in adults with Mild Cognitive Impairment (MCI). We are assessing safety and feasibility of this intervention, as well as using neuroimaging (fMRI) to assess improved connections in the default mode network. We will also be assessing the impact of this intervention on cognitive function and measures of well-being.
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome:

• Number of participants with adverse events [ Time Frame: 8 weeks ]
  Participants will inform us if they have had any adverse events during the study period and we will track to see if any occur for any of the participants
• Feasibility: 85% completion [ Time Frame: 8 weeks ]
  To judge the feasibility of the trial, recruitment efforts will be documented in terms of number of eligible patients approached, number who declined participation, number successfullyl recruited, and number who completed the trial. The trial will be feasible if 85% (the absolute percentage of patients) complete the trial.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in fMRI Resting state [ Time Frame: Change from baseline to 8 weeks ]
  Assessing fMRI resting state to assess if there are improved connections in the default mode network (between the posterior cingulate cortex, the medial prefrontal cortex, and the hippocampus) after participating in MBSR
• Change in Cognition [ Time Frame: Change from baseline to 8 weeks ]
  Assessing if there are any improvements in cognition (global functioning, episodic memory, attention, executive function, and language) after adults participate in MBSR.
• Change in Measures of "well-being" [ Time Frame: Change from baseline to 8 weeks ]
  Assessing if there is any improvement in measures of well-being (quality of life, stress, anxiety, depression, rumination, neuroticism, optimism, hope, resilience, and mindfulness) after participating in MBSR
• Qualitative Improvements [ Time Frame: 8 weeks ]
  Semi-structured interviews will be conducted to assess if any qualitative improvements

Original Secondary Outcome: Same as current

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: May 13, 2012
Date Started: January 2010
Date Completion:
Last Updated: May 21, 2012
Last Verified: May 2012