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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02888600
Recruitment Status : Active, not recruiting
First Posted : September 5, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
University of Pittsburgh
Virginia Commonwealth University
Information provided by (Responsible Party):
Carnegie Mellon University

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE September 5, 2016
Last Update Posted Date October 8, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02888600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • Pro-inflammatory gene expression [ Time Frame: Change from baseline to 1-week post-intervention ]
  • Self-reported relational distress [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Evaluated using ecological momentary assessment
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2019)
  • 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
  • Mental health [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Beck Depression Inventory
  • Self-reported stress [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  • Mindfulness [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Mindful Attention Awareness Scale
  • Connectedness to nature [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Nature Connection Scale
  • Personality [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using NEO Personality Inventory
  • 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
  • Self-reported psychological distress [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  • 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
  • Trait hostility [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Cook-Medley Hostility Scale
  • Attachment style [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Adult Attachment Scale
  • Attitudes towards aging [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Attitudes to Aging Questionnaire
  • 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
  • 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
  • Cellular aging [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Assessed via telomeres and telomerase
  • Markers of inflammation [ Time Frame: Assessed at 3-month follow-up only ]
    Assessed via hair sample
  • Social interaction quality and quantity [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment
  • Self-reported psychological distress [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment
  • 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.
  • 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,
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: August 30, 2016)
  • 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
  • Mental health [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Beck Depression Inventory
  • Self-reported stress [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  • Mindfulness [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Mindful Attention Awareness Scale
  • Connectedness to nature [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Nature Connection Scale
  • Personality [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using NEO Personality Inventory
  • 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
  • Self-reported psychological distress [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
  • 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
  • Trait hostility [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Cook-Medley Hostility Scale
  • Attachment style [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Adult Attachment Scale
  • Attitudes towards aging [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Evaluated using Attitudes to Aging Questionnaire
  • 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
  • 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
  • Cellular aging [ Time Frame: Change from baseline to 1-week post-intervention and 3-month follow-up ]
    Assessed via telomeres and telomerase
  • Markers of inflammation [ Time Frame: Assessed at 3-month follow-up only ]
    Assessed via hair sample
  • Social interaction quality and quantity [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment
  • Self-reported psychological distress [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via ecological momentary assessment
  • Rest and activity cycles [ Time Frame: Change from Baseline to Intervention Weeks 4 and 8 ]
    Assessed via actigraphy
  • 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.
  • 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,
  • 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
 
Descriptive Information
Brief Title  ICMJE Stress Management Training for Healthy Aging
Official Title  ICMJE Stress Management Training for Healthy Aging
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Psychological Stress
  • Loneliness
Intervention  ICMJE
  • Behavioral: Mindfulness Training
    Guided mindfulness meditation and stress management training
  • Behavioral: Health Education
    Guided health education and stress management training
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness 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
    Intervention: Behavioral: Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
190
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2016)
188
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

  • [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 93 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02888600
Other Study ID Numbers  ICMJE 1R01AT008685-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carnegie Mellon University
Study Sponsor  ICMJE Carnegie Mellon University
Collaborators  ICMJE
  • University of Pittsburgh
  • Virginia Commonwealth University
Investigators  ICMJE
Study Chair: Rebecca Pawlikowsky, BA Office of Sponsored Projects, Carnegie Mellon University
PRS Account Carnegie Mellon University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP