Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Management Training for Healthy Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02888600
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
University of Pittsburgh
Virginia Commonwealth University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psychological Stress Loneliness Behavioral: Mindfulness Training Behavioral: Health Education Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Stress Management Training for Healthy Aging
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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




Primary Outcome Measures :
  1. Circulating markers of inflammation, Interleukin-6 and C Reactive Protein [ Time Frame: 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 [ Time Frame: Change from baseline to 1-week post-intervention ]
  2. Self-reported relational distress [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Evaluated using ecological momentary assessment

  3. Self-reported loneliness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Beck Depression Inventory

  3. Self-reported stress [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  4. Mindfulness [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Mindful Attention Awareness Scale

  5. Connectedness to nature [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Nature Connection Scale

  6. Personality [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using NEO Personality Inventory

  7. Social network and social support [ Time Frame: 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 [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  9. Trait affect [ Time Frame: 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 [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Cook-Medley Hostility Scale

  11. Attachment style [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Adult Attachment Scale

  12. Attitudes towards aging [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Attitudes to Aging Questionnaire

  13. Resting thought listing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Assessed via telomeres and telomerase

  16. Markers of inflammation [ Time Frame: Assessed at 3-month follow-up only ]
    Assessed via hair sample

  17. Social interaction quality and quantity [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment

  18. Self-reported psychological distress [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment

  19. Home practice quality and quantity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8 ]
    Assessed by self-report ratings of patient-provider connection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 93 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888600


Contacts
Layout table for location contacts
Contact: J. David Creswell, Ph.D. 412-268-9182 creswell@cmu.edu
Contact: Sarah Lipitz, B.S. 412-268-5558 slipitz@andrew.cmu.edu

Locations
Layout table for location information
United States, Pennsylvania
Carnegie Mellon University Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: J. David Creswell, Ph.D.    412-268-9182    creswell@cmu.edu   
Contact: Sarah Lipitz, B.S.    4122685558    slipitz@andrew.cmu.edu   
Sub-Investigator: Emily Lindsay, MS         
Sub-Investigator: Hayley Rahl, BS         
Sub-Investigator: Brian Chin, BS         
Principal Investigator: J. David Creswell, Ph.D.         
University of Pittsburgh Medical Center- Center for Integrative Medicine Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Carol Greco, Ph.D.    412-623-6873    grecocm@upmc.edu   
Sub-Investigator: Scott Beach, Ph.D.         
Principal Investigator: Carol Greco, Ph.D.         
Sub-Investigator: Anna Marsland, Ph.D.         
Sub-Investigator: Richard Schulz, Ph.D.         
Sub-Investigator: Aidan Wright, Ph.D.         
United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23284
Contact: Kirk Brown, Ph.D.    804-828-6754    kwbrown@vcu.edu   
Principal Investigator: Kirk Brown, Ph.D.         
Sponsors and Collaborators
Carnegie Mellon University
University of Pittsburgh
Virginia Commonwealth University
Investigators
Layout table for investigator information
Study Chair: Rebecca Pawlikowsky, BA Office of Sponsored Projects, Carnegie Mellon University

Layout table for additonal information
Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02888600     History of Changes
Other Study ID Numbers: 1R01AT008685-01 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress, Psychological
Behavioral Symptoms