Stress Management Training for Healthy Aging
Primary Purpose
Psychological Stress, Loneliness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Health Education
Sponsored by
About this trial
This is an interventional basic science trial for Psychological Stress
Eligibility Criteria
Inclusion Criteria:
- English speaking
Exclusion Criteria:
- [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Sites / Locations
- Carnegie Mellon University
- University of Pittsburgh Medical Center- Center for Integrative Medicine
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mindfulness Training
Health Education
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Circulating markers of inflammation, Interleukin-6 and C Reactive Protein
Measured via blood samples
Secondary Outcome Measures
Pro-inflammatory gene expression
Self-reported relational distress
Evaluated using ecological momentary assessment
Self-reported loneliness
Evaluated using UCLA loneliness scale and ecological momentary assessment
Full Information
NCT ID
NCT02888600
First Posted
August 15, 2016
Last Updated
January 25, 2021
Sponsor
Carnegie Mellon University
Collaborators
University of Pittsburgh, Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT02888600
Brief Title
Stress Management Training for Healthy Aging
Official Title
Stress Management Training for Healthy Aging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2016 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
November 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carnegie Mellon University
Collaborators
University of Pittsburgh, Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Loneliness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
Guided mindfulness meditation and stress management training
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Guided health education and stress management training
Primary Outcome Measure Information:
Title
Circulating markers of inflammation, Interleukin-6 and C Reactive Protein
Description
Measured via blood samples
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Secondary Outcome Measure Information:
Title
Pro-inflammatory gene expression
Time Frame
Change from baseline to 1-week post-intervention
Title
Self-reported relational distress
Description
Evaluated using ecological momentary assessment
Time Frame
Change from Baseline to Intervention Weeks 4 and 8
Title
Self-reported loneliness
Description
Evaluated using UCLA loneliness scale and ecological momentary assessment
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Other Pre-specified Outcome Measures:
Title
Health practices
Description
Evaluated by questionnaires asking about diet, caffeine consumption, alcohol use, stress reduction, exercise, recreational drug use, cold or flu, flu shots
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Mental health
Description
Evaluated using Beck Depression Inventory
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Self-reported stress
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Mindfulness
Description
Evaluated using Mindful Attention Awareness Scale
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Connectedness to nature
Description
Evaluated using Nature Connection Scale
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Personality
Description
Evaluated using NEO Personality Inventory
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Social network and social support
Description
Evaluated using Social Network Index and Interpersonal Support Evaluation List
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Self-reported psychological distress
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Trait affect
Description
Evaluated using Stanford Measure of Actual, Ideal, and Avoided Affect
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Trait hostility
Description
Evaluated using Cook-Medley Hostility Scale
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Attachment style
Description
Evaluated using Adult Attachment Scale
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Attitudes towards aging
Description
Evaluated using Attitudes to Aging Questionnaire
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Resting thought listing
Description
Participants will sit quietly for 5 minutes and report all noticed experiences and reactivity to those experiences
Time Frame
Assessed at baseline, 1-week post-intervention, and 3-month follow-up
Title
Immune functioning
Description
Assessed via stimulated IL-6 production and glucocorticoid resistance
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Cellular aging
Description
Assessed via telomeres and telomerase
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow-up
Title
Markers of inflammation
Description
Assessed via hair sample
Time Frame
Assessed at 3-month follow-up only
Title
Social interaction quality and quantity
Description
Assessed via ecological momentary assessment
Time Frame
Change from Baseline to Intervention Weeks 4 and 8
Title
Self-reported psychological distress
Description
Assessed via ecological momentary assessment
Time Frame
Change from Baseline to Intervention Weeks 4 and 8
Title
Home practice quality and quantity
Description
Assessed by self-reported practice length, enjoyment of practice, usefulness of practice, trouble concentrating, mental fatigue, stress, and irritation during practice.
Time Frame
Assessed daily throughout the eight-week intervention period
Title
Treatment expectations
Description
Assessed by optimism about treatment and expectations for treatment outcome,
Time Frame
Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
Title
Instructor and class ratings
Description
Assessed by self-report ratings of patient-provider connection
Time Frame
Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
Title
Sleep measures
Description
Assessed by self-report ratings of sleep using Pittsburgh Sleep Quality Index
Time Frame
Change from baseline through intervention to 1-week post-intervention and 3-month follow up
Title
Physiological data (blood pressure, pulse rate)
Description
Assessed by blood pressure cuffs in lab
Time Frame
Change from baseline to 1-week post-intervention and 3-month follow up
Title
Physiological data (gait)
Description
Assessed by speed of walking at a normal pace
Time Frame
1-week post-intervention and 3-month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
93 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking
Exclusion Criteria:
[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Pawlikowsky, BA
Organizational Affiliation
Office of Sponsored Projects, Carnegie Mellon University
Official's Role
Study Chair
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Medical Center- Center for Integrative Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33657083
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.
Results Reference
derived
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Stress Management Training for Healthy Aging
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