Stress Management Training for Healthy Aging

Not Applicable

Completed

• Conditions: Loneliness; Psychological Stress
• Interventions: Behavioral: Health Education; Behavioral: Mindfulness Training

• Registration Number: NCT02888600
• Lead Sponsor: Carnegie Mellon University

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.

Study Timeline

• Study Start: 2016-06-28
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Primary Completion: 2020-02-21
• Study Completion: 2020-11-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• English speaking

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education	Health Education	The Health Education Program also consists of eight weekly 2- 2.5 hour group sessions, a day-long retreat in the sixth week, and daily health practice homework
Mindfulness Training	Mindfulness Training	The Mindfulness Meditation Program consists of eight weekly 2- 2.5 hour group sessions, a day-long retreat in the sixth week, and daily mindfulness meditation homework.

Primary Outcome Measures

Name	Time	Method
Circulating markers of inflammation, Interleukin-6 and C Reactive Protein	Change from baseline to 1-week post-intervention and 3-month follow-up	Measured via blood samples

Secondary Outcome Measures

Name	Time	Method
Pro-inflammatory gene expression	Change from baseline to 1-week post-intervention
Self-reported relational distress	Change from Baseline to Intervention Weeks 4 and 8	Evaluated using ecological momentary assessment
Self-reported loneliness	Change from baseline to 1-week post-intervention and 3-month follow-up	Evaluated using UCLA loneliness scale and ecological momentary assessment
Self-reported awareness of experiences and reactivity to experience during resting state	1-week post-intervention and 3-month follow-up	Questionnaire assessing the frequency in which participants notice a variety of positive, neutral, and negative experiences and their reactivity to those experiences during a 5-minute resting state period
Working memory in daily living	Change from baseline to intervention weeks 4 and 8	Assessed via a dot memory ambulatory smartphone-based task administered at six timepoints per day, for three days in a row, at baseline and at Intervention weeks 4 and 8
Implicit acceptance of self	1-week post-intervention and 3-month follow-up	Assessed via an Implicit Association Test (IAT) behaviorally quantifying the association between self and acceptance/judgment

Trial Locations

Locations (3)

University of Pittsburgh Medical Center- Center for Integrative Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Carnegie Mellon University; 🇺🇸 Pittsburgh, Pennsylvania, United States