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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Virginia Commonwealth University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training | Active Comparator | 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. |
|
| Health Education | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training | Behavioral | Guided mindfulness meditation and stress management training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circulating markers of inflammation, Interleukin-6 and C Reactive Protein | Measured via blood samples | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory gene expression | Change from baseline to 1-week post-intervention | |
| Self-reported relational distress | Evaluated using ecological momentary assessment | Change from Baseline to Intervention Weeks 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Health practices | Evaluated by questionnaires asking about diet, caffeine consumption, alcohol use, stress reduction, exercise, recreational drug use, cold or flu, flu shots | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Mental health |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Pawlikowsky, BA | Office of Sponsored Projects, Carnegie Mellon University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Pittsburgh Medical Center- Center for Integrative Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37982547 | Derived | Lindsay EK, Marsland AL, Cole SW, Dutcher JM, Greco CM, Wright AGC, Brown KW, Creswell JD. Mindfulness-Based Stress Reduction Reduces Proinflammatory Gene Regulation But Not Systemic Inflammation Among Older Adults: A Randomized Controlled Trial. Psychosom Med. 2024 Jun 1;86(5):463-472. doi: 10.1097/PSY.0000000000001264. Epub 2023 Nov 17. | |
| 33657083 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 31, 2019 | Jan 25, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Health Education | Behavioral | Guided health education and stress management training |
|
| Self-reported loneliness | Evaluated using UCLA loneliness scale and ecological momentary assessment | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Self-reported awareness of experiences and reactivity to experience during resting state | 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 | 1-week post-intervention and 3-month follow-up |
| Working memory in daily living | 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 | Change from baseline to intervention weeks 4 and 8 |
| Implicit acceptance of self | Assessed via an Implicit Association Test (IAT) behaviorally quantifying the association between self and acceptance/judgment | 1-week post-intervention and 3-month follow-up |
Evaluated using Beck Depression Inventory |
| Change from baseline to 1-week post-intervention and 3-month follow-up |
| Self-reported stress | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Mindfulness | Evaluated using Mindful Attention Awareness Scale | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Connectedness to nature | Evaluated using Nature Connection Scale | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Personality | Evaluated using NEO Personality Inventory | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Social network and social support | Evaluated using Social Network Index and Interpersonal Support Evaluation List | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Self-reported psychological distress | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Trait affect | Evaluated using Stanford Measure of Actual, Ideal, and Avoided Affect | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Trait hostility | Evaluated using Cook-Medley Hostility Scale | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Attachment style | Evaluated using Adult Attachment Scale | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Attitudes towards aging | Evaluated using Attitudes to Aging Questionnaire | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Immune functioning | Assessed via stimulated IL-6 production and glucocorticoid resistance | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Cellular aging | Assessed via telomeres and telomerase | Change from baseline to 1-week post-intervention and 3-month follow-up |
| Markers of inflammation | Assessed via hair sample | Assessed at 3-month follow-up only |
| Social interaction quality and quantity | Assessed via ecological momentary assessment | Change from Baseline to Intervention Weeks 4 and 8 |
| Self-reported psychological distress | Assessed via ecological momentary assessment | Change from Baseline to Intervention Weeks 4 and 8 |
| Home practice quality and quantity | Assessed by self-reported practice length, enjoyment of practice, usefulness of practice, trouble concentrating, mental fatigue, stress, and irritation during practice. | Assessed daily throughout the eight-week intervention period |
| Treatment expectations | Assessed by optimism about treatment and expectations for treatment outcome, | Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8 |
| Instructor and class ratings | Assessed by self-report ratings of patient-provider connection | Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8 |
| Sleep measures | Assessed by self-report ratings of sleep using Pittsburgh Sleep Quality Index | Change from baseline through intervention to 1-week post-intervention and 3-month follow up |
| Physiological data (blood pressure, pulse rate) | Assessed by blood pressure cuffs in lab | Change from baseline to 1-week post-intervention and 3-month follow up |
| Physiological data (gait) | Assessed by speed of walking at a normal pace | 1-week post-intervention and 3-month follow up |
| Perceptual speed and visual attention in daily living | 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 | Change from baseline to intervention weeks 4 and 8 |
| Attentional interference from emotional and social information | Emotional Stroop task with negative social, negative non-social, positive social, and positive non-social words | 1-week post-intervention |
| Recall of social and emotional information | A social memory task assessing event recall based on event sociality (collective, interpersonal, and individual) and valence (positive and negative) | 1-week post-intervention |
| Selective auditory attention | Assessed via a dichotic listening task | 1-week post-intervention and 3-month follow-up |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |