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Completed

NCT Number: NCT02888600

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.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Loneliness Stress, Psychological

Age range

65 year–93 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking

Exclusion criteria

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

Treatment and study plan

Mindfulness Training

Behavioral

Guided mindfulness meditation and stress management training

Health Education

Behavioral

Guided health education and stress management training

Primary outcomes

  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 outcomes

  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

  4. Self-reported awareness of experiences and reactivity to experience during resting state

    Time frame: 1-week post-intervention and 3-month follow-up

    Questionnaire assessing the frequency in which participants notice a variety of positive, neutral, and negative experiences and their reactivity to those experiences during a 5-minute resting state period

  5. Working memory in daily living

    Time frame: Change from baseline to intervention weeks 4 and 8

    Assessed via a dot memory ambulatory smartphone-based task administered at six timepoints per day, for three days in a row, at baseline and at Intervention weeks 4 and 8

  6. Implicit acceptance of self

    Time frame: 1-week post-intervention and 3-month follow-up

    Assessed via an Implicit Association Test (IAT) behaviorally quantifying the association between self and acceptance/judgment

Other outcomes

  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. 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

  14. Cellular aging

    Time frame: Change from baseline to 1-week post-intervention and 3-month follow-up

    Assessed via telomeres and telomerase

  15. Markers of inflammation

    Time frame: Assessed at 3-month follow-up only

    Assessed via hair sample

  16. Social interaction quality and quantity

    Time frame: Change from Baseline to Intervention Weeks 4 and 8

    Assessed via ecological momentary assessment

  17. Self-reported psychological distress

    Time frame: Change from Baseline to Intervention Weeks 4 and 8

    Assessed via ecological momentary assessment

  18. 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.

  19. 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,

  20. 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

  21. Sleep measures

    Time frame: 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

  22. Physiological data (blood pressure, pulse rate)

    Time frame: Change from baseline to 1-week post-intervention and 3-month follow up

    Assessed by blood pressure cuffs in lab

  23. Physiological data (gait)

    Time frame: 1-week post-intervention and 3-month follow up

    Assessed by speed of walking at a normal pace

  24. Perceptual speed and visual attention in daily living

    Time frame: Change from baseline to intervention weeks 4 and 8

    Assessed via a symbol search ambulatory smartphone-based task administered at six timepoints per day, for three days in a row, at baseline and at Intervention weeks 4 and 8

  25. Attentional interference from emotional and social information

    Time frame: 1-week post-intervention

    Emotional Stroop task with negative social, negative non-social, positive social, and positive non-social words

  26. Recall of social and emotional information

    Time frame: 1-week post-intervention

    A social memory task assessing event recall based on event sociality (collective, interpersonal, and individual) and valence (positive and negative)

  27. Selective auditory attention

    Time frame: 1-week post-intervention and 3-month follow-up

    Assessed via a dichotic listening task

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • University of Pittsburgh
  • Virginia Commonwealth University

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2016
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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