Mindfulness to Improve Elders' Immune and Health Status

University of Rochester

Status: Completed

Conditions: Stress, Psychologic

Treatments: Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01027780

1R01AG025474

R01AG025474 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. To examine whether treatment effects are moderated by age, personality traits, physical health status, or depression.
3. To examine the effects of behavioral, psychological, and physiological mediators of immune outcome.

Enrollment: 208 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 65 or older
• English speaking
• If prescribed antidepressant or anxiolytic medications, must have maintained a stable regimen for eight weeks prior to enrolling

Exclusion criteria

• receiving immunosuppressive therapy for cancer or other diseases
• major, uncorrected sensory impairments
• cognitive deficits (MMSE <25, or deficits deemed significant enough to interfere)
• history of a psychotic disorder, bipolar disorder, organic brain syndrome, or mental retardation
• alcohol or substance abuse within the previous year
• severe cardiovascular disease
• known allergies to shellfish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Active Comparator group

Description:

Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Wait-list control

No Intervention group

Description:

Wait-list control participants were offered MBSR training after completion of their primary assessments periods.