Mindfulness to Improve Elders' Immune and Health Status
The purpose of the study is to better understand effects of the Mindfulness-Based Stress-Reduction (MBSR) program on the physical and emotional health and well-being of adults ages 65 and older.
The effects MBSR may have on the immune system is investigated, including how these effects relate to factors such as perceived health, psychological well-being, age, personality, and mood.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mindfulness to Improve Elders' Immune and Health Status|
- Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH). [ Time Frame: Immediate post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
- Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
- Mindful Attention Awareness Scale (Brown, K. W., & Ryan, R. M. (2003)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
- Physical health status as potential moderator of treatment effects—including medical history, symptom checklist, CHAMPS Physical Activity Questionnaire for Older Adults (Stewart, A. L., et. al. (2001)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
- Mood as potential mediator or moderator of treatment effects—including Hamilton Depression Rating Scale (HDRS); Center for Epidemiologic Studies Depression Scale, revised (CESD-R) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
- Personality traits as potential moderators of treatment effects (NEO-FFI; Mccrae, R. R., & Costa, P. T. (1992)) [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Mindfulness-Based Stress Reduction
Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
Behavioral: Mindfulness-Based Stress Reduction
The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing.
No Intervention: Wait-list control
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
This study investigates the effects of Mindfulness-Based Stress Reduction (MBSR) on immune responses to multiple concentrations of keyhole limpet hemocyanin (KLH) in elderly volunteers. The research design thus capitalizes on the antibody response to a novel, benign antigen to which our subjects will be immunologically naïve. The use of a range of antigen concentrations will provide a sensitive indicator for the effects of intervention.
The Aims of the study are the following:
- To examine the effects of Mindfulness Based Stress Reduction (MBSR) on immunological outcomes, perceived health, and psychological well-being in a sample of seniors 65 years of age and older.
- To examine whether treatment effects are moderated by age, personality traits, physical health status, or depression.
- To examine the effects of behavioral, psychological, and physiological mediators of immune outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027780
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Jan A Moynihan, Ph.D||University of Rochester|