Mind-body Interventions for Healthy Aging (HealthyAgers)
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|ClinicalTrials.gov Identifier: NCT03626532|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging||Behavioral: Mindfulness-Based Stress Reduction (MBSR) Behavioral: Lifestyle Education (LifeEd)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Single-blind. Any investigators administering assessments will be blind to participants' group allocation.|
|Official Title:||Mind-body Interventions for Healthy Aging|
|Actual Study Start Date :||August 17, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Mindfulness-Based Stress Reduction
Participants will meet once a week for 8 weeks (2.5 hours per session), plus a 4-hour retreat day, to engage in mindfulness meditation exercises. Didactic components will include oral presentations, informational videos, and group discussion. Additionally, daily homework assignments will require participants to engage in guided practices for 30 minutes a day for 5 days a week.
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
The MBSR program is a mind-body approach developed by Kabat-Zinn to reduce pain and stress through mindfulness meditation. MBSR is a form of mental training characterized by the self-regulation of attention and focal orientation to present moment experiences. Mindfulness practice is thought to effectively promote emotional and cognitive control. Mindfulness includes directing awareness away from thoughts, emotions and sensations towards some specific "anchor" to the present, such as the breath. Participants will engage in various practices including breath awareness, body scans, mindful listening, etc.
Other Name: MBSR
Active Comparator: Lifestyle Education
Participants will meet once a week for 2.5 hours for 8 weeks, plus a 4-hour retreat day, to engage in light stretching exercises and interactive discussions on health topics, such as physical activity, nutrition, sleep, stress, etc. Didactic components will include oral presentations, informational videos, and group discussion. Additionally, daily homework assignments will ask participants to engage in stretching, read or watch informational content, and answer reflection questions for 30 minutes a day for 5 days a week.
Behavioral: Lifestyle Education (LifeEd)
This group will engage in light stretching exercises at each session. They will also be provided with information drawn from the scientific literature on topics related to healthy aging, including physical activity, sedentary behavior, nutrition, hydration, stress, sleep, and cognitively stimulating activities. Group discussion will be incorporated throughout.
Other Name: LifeEd
- Change in attentional control on tasks of sustained attention [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will complete computerized measures of Continuous Performance Test and Go/No-Go Task to assess sustained attention. Detectability (d') measures will be calculated to assess the effects of mind-body interventions on attentional control. Data collected at 8-months and 14-month will be used to determine maintenance effects.
- Change in neural functioning during measures of attentional control [ Time Frame: Baseline, 2 months, 14 months ]Participants will complete an functional magnetic resonance imaging (fMRI) assessment before and after the intervention. Functional connectivity changes will be examined during tasks of attentional control to determine neural correlates of mind-body interventions.
- Change in mind-wandering on tasks of sustained attention [ Time Frame: Baseline, 2 months, 8 months, 14 months ]To measure mind-wandering, participants will also be prompted with quasi-random probes asking them to categorize the thoughts they were having immediately preceding the probe.
- Change in emotion regulation strategy sse [ Time Frame: Baseline, 2 months, 8months, 14 months ]Participants will complete lab-based and ecological momentary assessment (EMA)-based emotion regulation strategy use tasks to determine change in ER strategy use following mind-body interventions.
- Change in cognitive performance on the NIH Cognitive Toolbox Battery [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will perform the NIH Cognitive Toolbox Battery comprised of seven different tasks aimed at measuring episodic memory, executive function, attention, working memory, language, and processing speed. Change on this measure will be assessed to determine the impact of the mind-body interventions on various domains of cognitive functioning.
- Change in Measure of Daily Functioning [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will complete the Driving Scenes subtest of the Neuropsychological Assessment Battery (NAB) as a measure of everyday cognition. This subtest measures attention and working memory to changing driving scenes.
- Change in inflammatory biomarkers [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Data on inflammatory markers - C-reactive protein (CRP), interleukin 6 (IL-6), and interleukin 10 (IL-10) - will be collected to determine the impact of mind-body interventions on systemic markers of inflammation.
- Change in self-report measures of stress [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will be administered the Perceived Stress Scale (PSS) to measure changes in self-reported perceived stress following mind-body interventions. This measure has 10 items, each measured on a 5-point rating scale. One total score will be calculated by summing the individual item responses. Higher scores represent greater feelings of stress, unpredictability, and uncontrollability.
- Change in self-report measures of emotion dysregulation [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will be administered the Difficulties in Emotion Regulation Scale (DERS) to examine changes in degree of self-reported emotion dysregulation following mind-body interventions. This measure has 36 items, each measured on a 5-point rating scale. One total score will be calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.
- Change in self-report measures of quality of life [ Time Frame: Baseline, 2 months, 8 months, 14 months ]Participants will be administered the The World Health Organization Quality of Life abbreviated scale (WHOQOL-BREF) to examine changes in self-reported quality of life following mind-body interventions. This measure has 26 items, each measured on a 5-point rating scale. Four domains are measured by taking the average of representative items: psychological (six items), environmental (eight items), physical health (seven items), and social relationships (three items), as well as overall QoL (two items). Higher scores represent better perceived quality of life.
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): NCT03626532
|Contact: Joanna Salerno, BAfirstname.lastname@example.org|
|United States, Ohio|
|Department of Psychology, The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Ruchika Prakash, PhD 614-292-8462 email@example.com|
|Principal Investigator:||Ruchika Prakash, Ph.D.||The Ohio State Universty|