Stress Management Training for Healthy Aging

Sponsor
Carnegie Mellon University (Other)
Overall Status
Completed
CT.gov ID
NCT02888600
Collaborator
University of Pittsburgh (Other), Virginia Commonwealth University (Other)
190
3
2
53.1
63.3
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Training
  • Behavioral: Health Education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Stress Management Training for Healthy Aging
Actual Study Start Date :
Jun 28, 2016
Actual Primary Completion Date :
Feb 21, 2020
Actual Study Completion Date :
Nov 29, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Pro-inflammatory gene expression [Change from baseline to 1-week post-intervention]

  2. Self-reported relational distress [Change from Baseline to Intervention Weeks 4 and 8]

    Evaluated using ecological momentary assessment

  3. 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

Other Outcome Measures

  1. Health practices [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated by questionnaires asking about diet, caffeine consumption, alcohol use, stress reduction, exercise, recreational drug use, cold or flu, flu shots

  2. Mental health [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Beck Depression Inventory

  3. Self-reported stress [Change from baseline to 1-week post-intervention and 3-month follow-up]

  4. Mindfulness [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Mindful Attention Awareness Scale

  5. Connectedness to nature [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Nature Connection Scale

  6. Personality [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using NEO Personality Inventory

  7. Social network and social support [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Social Network Index and Interpersonal Support Evaluation List

  8. Self-reported psychological distress [Change from baseline to 1-week post-intervention and 3-month follow-up]

  9. Trait affect [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Stanford Measure of Actual, Ideal, and Avoided Affect

  10. Trait hostility [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Cook-Medley Hostility Scale

  11. Attachment style [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Adult Attachment Scale

  12. Attitudes towards aging [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Evaluated using Attitudes to Aging Questionnaire

  13. Resting thought listing [Assessed at baseline, 1-week post-intervention, and 3-month follow-up]

    Participants will sit quietly for 5 minutes and report all noticed experiences and reactivity to those experiences

  14. Immune functioning [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Assessed via stimulated IL-6 production and glucocorticoid resistance

  15. Cellular aging [Change from baseline to 1-week post-intervention and 3-month follow-up]

    Assessed via telomeres and telomerase

  16. Markers of inflammation [Assessed at 3-month follow-up only]

    Assessed via hair sample

  17. Social interaction quality and quantity [Change from Baseline to Intervention Weeks 4 and 8]

    Assessed via ecological momentary assessment

  18. Self-reported psychological distress [Change from Baseline to Intervention Weeks 4 and 8]

    Assessed via ecological momentary assessment

  19. Home practice quality and quantity [Assessed daily throughout the eight-week intervention period]

    Assessed by self-reported practice length, enjoyment of practice, usefulness of practice, trouble concentrating, mental fatigue, stress, and irritation during practice.

  20. Treatment expectations [Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8]

    Assessed by optimism about treatment and expectations for treatment outcome,

  21. Instructor and class ratings [Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8]

    Assessed by self-report ratings of patient-provider connection

  22. Sleep measures [Change from baseline through intervention to 1-week post-intervention and 3-month follow up]

    Assessed by self-report ratings of sleep using Pittsburgh Sleep Quality Index

  23. Physiological data (blood pressure, pulse rate) [Change from baseline to 1-week post-intervention and 3-month follow up]

    Assessed by blood pressure cuffs in lab

  24. Physiological data (gait) [1-week post-intervention and 3-month follow up]

    Assessed by speed of walking at a normal pace

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 93 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • English speaking
Exclusion Criteria:
  • [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carnegie Mellon University Pittsburgh Pennsylvania United States 15213
2 University of Pittsburgh Medical Center- Center for Integrative Medicine Pittsburgh Pennsylvania United States 15232
3 Virginia Commonwealth University Richmond Virginia United States 23284

Sponsors and Collaborators

  • Carnegie Mellon University
  • University of Pittsburgh
  • Virginia Commonwealth University

Investigators

  • Study Chair: Rebecca Pawlikowsky, BA, Office of Sponsored Projects, Carnegie Mellon University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Carnegie Mellon University
ClinicalTrials.gov Identifier:
NCT02888600
Other Study ID Numbers:
  • 1R01AT008685-01
First Posted:
Sep 5, 2016
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021