Clinical trial NCT02888600: Stress Management Training for Healthy Aging
Official title: Stress Management Training for Healthy Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Loneliness
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Virginia Commonwealth University
First posted: 2016-09-05
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Maximum age (years): 93
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a two-arm randomized controlled trial comparing two 8-week stress management programs for reducing inflammation and improving well-being among older adults.

Detailed description: A growing body of literature has demonstrated how stress can affect social relationships, health, and well-being during the aging process. Here, the investigators will test how two different programs can be used to facilitate healthy aging by helping individuals manage stress. One program will teach participants mindfulness meditation techniques while the other will educate participants about how to manage their health.

N=188 older adults will visit the study's central laboratory for a baseline visit and complete several days of daily experience sampling before being randomized into one of the two 8-week stress management programs. Participants will complete several days of daily experience sampling at the midpoint and conclusion of the intervention before returning to a study site to complete a follow-up assessment at both 1-week and 3-months after the end of the program.

This project will provide important information about how each training program can be used to promote well-being, health, and better social functioning in older adults. This work will ultimately inform the design of more efficacious and efficient stress-management interventions to facilitate healthy aging.

Eligibility criteria: Inclusion Criteria:

* English speaking

Exclusion Criteria:

* \[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.\]

Primary outcomes:
measure: Circulating markers of inflammation, Interleukin-6 and C Reactive Protein
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
Secondary outcomes:
measure: Pro-inflammatory gene expression
timeFrame: Change from baseline to 1-week post-intervention
measure: Self-reported relational distress
timeFrame: Change from Baseline to Intervention Weeks 4 and 8
measure: Self-reported loneliness
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Self-reported awareness of experiences and reactivity to experience during resting state
timeFrame: 1-week post-intervention and 3-month follow-up
measure: Working memory in daily living
timeFrame: Change from baseline to intervention weeks 4 and 8
measure: Implicit acceptance of self
timeFrame: 1-week post-intervention and 3-month follow-up
Other outcomes:
measure: Health practices
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Mental health
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Self-reported stress
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Mindfulness
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Connectedness to nature
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Personality
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Social network and social support
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Self-reported psychological distress
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Trait affect
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Trait hostility
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Attachment style
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Attitudes towards aging
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Immune functioning
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Cellular aging
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow-up
measure: Markers of inflammation
timeFrame: Assessed at 3-month follow-up only
measure: Social interaction quality and quantity
timeFrame: Change from Baseline to Intervention Weeks 4 and 8
measure: Self-reported psychological distress
timeFrame: Change from Baseline to Intervention Weeks 4 and 8
measure: Home practice quality and quantity
timeFrame: Assessed daily throughout the eight-week intervention period
measure: Treatment expectations
timeFrame: Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
measure: Instructor and class ratings
timeFrame: Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
measure: Sleep measures
timeFrame: Change from baseline through intervention to 1-week post-intervention and 3-month follow up
measure: Physiological data (blood pressure, pulse rate)
timeFrame: Change from baseline to 1-week post-intervention and 3-month follow up
measure: Physiological data (gait)
timeFrame: 1-week post-intervention and 3-month follow up
measure: Perceptual speed and visual attention in daily living
timeFrame: Change from baseline to intervention weeks 4 and 8
measure: Attentional interference from emotional and social information
timeFrame: 1-week post-intervention
measure: Recall of social and emotional information
timeFrame: 1-week post-intervention
measure: Selective auditory attention
timeFrame: 1-week post-intervention and 3-month follow-up
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center- Center for Integrative Medicine
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Office of Sponsored Projects, Carnegie Mellon University
name: Rebecca Pawlikowsky, BA
role: STUDY_CHAIR
References:
citation: Lindsay EK, Creswell JD, Stern HJ, Greco CM, Dutcher JM, Lipitz S, Walsh CP, Wright AGC, Brown KW, Marsland AL. Mindfulness-Based Stress Reduction Buffers Glucocorticoid Resistance Among Older Adults: A Randomized Controlled Trial. Psychosom Med. 2021 Jul-Aug 01;83(6):641-649. doi: 10.1097/PSY.0000000000000928.