Stress Management Training for Healthy Aging

Loneliness Clinical Trial

Official title:

Stress Management Training for Healthy Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888600
• Other study ID #: 1R01AT008685-01
• Status: Completed
• Phase: N/A
• Start date: June 28, 2016
• Est. completion date: November 29, 2020

Study information

• Verified date: February 2024
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 29, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 93 Years

Eligibility

Inclusion Criteria:

• English speaking

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Loneliness
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Mindfulness Training
Guided mindfulness meditation and stress management training
• Health Education
Guided health education and stress management training

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center- Center for Integrative Medicine	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Carnegie Mellon University	University of Pittsburgh, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Mental health	Evaluated using Beck Depression Inventory	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Self-reported stress		Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Mindfulness	Evaluated using Mindful Attention Awareness Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Connectedness to nature	Evaluated using Nature Connection Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Personality	Evaluated using NEO Personality Inventory	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	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
Other	Self-reported psychological distress		Change from baseline to 1-week post-intervention and 3-month follow-up
Other	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
Other	Trait hostility	Evaluated using Cook-Medley Hostility Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Attachment style	Evaluated using Adult Attachment Scale	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Attitudes towards aging	Evaluated using Attitudes to Aging Questionnaire	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Resting thought listing	Participants will sit quietly for 5 minutes and report all noticed experiences and reactivity to those experiences	Assessed at baseline, 1-week post-intervention, and 3-month follow-up
Other	Immune functioning	Assessed via stimulated IL-6 production and glucocorticoid resistance	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Cellular aging	Assessed via telomeres and telomerase	Change from baseline to 1-week post-intervention and 3-month follow-up
Other	Markers of inflammation	Assessed via hair sample	Assessed at 3-month follow-up only
Other	Social interaction quality and quantity	Assessed via ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Other	Self-reported psychological distress	Assessed via ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Other	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
Other	Treatment expectations	Assessed by optimism about treatment and expectations for treatment outcome,	Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8
Other	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
Other	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
Other	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
Other	Physiological data (gait)	Assessed by speed of walking at a normal pace	1-week post-intervention and 3-month follow up
Primary	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
Secondary	Pro-inflammatory gene expression		Change from baseline to 1-week post-intervention
Secondary	Self-reported relational distress	Evaluated using ecological momentary assessment	Change from Baseline to Intervention Weeks 4 and 8
Secondary	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