Stress Management Training for Healthy Aging

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.

Study Overview

• Status: Completed
• Conditions: Loneliness; Psychological Stress
• Intervention / Treatment: Behavioral: Mindfulness Training; Behavioral: Health Education

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center- Center for Integrative Medicine
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 93 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Mindfulness Training; Guided mindfulness meditation and stress management training
Active Comparator: 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	Behavioral: Health Education; Guided health education and stress management training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory gene expression		Change from baseline to 1-week post-intervention
Self-reported relational distress	Evaluated using ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Self-reported loneliness	Evaluated using UCLA loneliness scale and ecological momentary assessment	Change from baseline to 1-week post-intervention and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health practices	Evaluated by questionnaires asking about diet, caffeine consumption, alcohol use, stress reduction, exercise, recreational drug use, cold or flu, flu shots	Change from baseline to 1-week post-intervention and 3-month follow-up
Mental health	Evaluated using Beck Depression Inventory	Change from baseline to 1-week post-intervention and 3-month follow-up
Self-reported stress		Change from baseline to 1-week post-intervention and 3-month follow-up
Mindfulness	Evaluated using Mindful Attention Awareness Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Connectedness to nature	Evaluated using Nature Connection Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Personality	Evaluated using NEO Personality Inventory	Change from baseline to 1-week post-intervention and 3-month follow-up
Social network and social support	Evaluated using Social Network Index and Interpersonal Support Evaluation List	Change from baseline to 1-week post-intervention and 3-month follow-up
Self-reported psychological distress		Change from baseline to 1-week post-intervention and 3-month follow-up
Trait affect	Evaluated using Stanford Measure of Actual, Ideal, and Avoided Affect	Change from baseline to 1-week post-intervention and 3-month follow-up
Trait hostility	Evaluated using Cook-Medley Hostility Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Attachment style	Evaluated using Adult Attachment Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Attitudes towards aging	Evaluated using Attitudes to Aging Questionnaire	Change from baseline to 1-week post-intervention and 3-month follow-up
Resting thought listing	Participants will sit quietly for 5 minutes and report all noticed experiences and reactivity to those experiences	Assessed at baseline, 1-week post-intervention, and 3-month follow-up
Immune functioning	Assessed via stimulated IL-6 production and glucocorticoid resistance	Change from baseline to 1-week post-intervention and 3-month follow-up
Cellular aging	Assessed via telomeres and telomerase	Change from baseline to 1-week post-intervention and 3-month follow-up
Markers of inflammation	Assessed via hair sample	Assessed at 3-month follow-up only
Social interaction quality and quantity	Assessed via ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Self-reported psychological distress	Assessed via ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Home practice quality and quantity	Assessed by self-reported practice length, enjoyment of practice, usefulness of practice, trouble concentrating, mental fatigue, stress, and irritation during practice.	Assessed daily throughout the eight-week intervention period
Treatment expectations	Assessed by optimism about treatment and expectations for treatment outcome,	Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
Instructor and class ratings	Assessed by self-report ratings of patient-provider connection	Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
Sleep measures	Assessed by self-report ratings of sleep using Pittsburgh Sleep Quality Index	Change from baseline through intervention to 1-week post-intervention and 3-month follow up
Physiological data (blood pressure, pulse rate)	Assessed by blood pressure cuffs in lab	Change from baseline to 1-week post-intervention and 3-month follow up
Physiological data (gait)	Assessed by speed of walking at a normal pace	1-week post-intervention and 3-month follow up

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: University of Pittsburgh; Virginia Commonwealth University
• Investigators: Study Chair: Rebecca Pawlikowsky, BA, Office of Sponsored Projects, Carnegie Mellon University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): November 29, 2020

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimated): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 1R01AT008685-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO