NCT02888600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2020

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

3.7 years

First QC Date

August 15, 2016

Last Update Submit

October 21, 2024

Conditions

Psychological StressLoneliness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pro-inflammatory gene expression

    Change from baseline to 1-week post-intervention

  • Self-reported relational distress

    Change from Baseline to Intervention Weeks 4 and 8

  • Self-reported loneliness

    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

    1-week post-intervention and 3-month follow-up

  • Working memory in daily living

    Change from baseline to intervention weeks 4 and 8

  • +1 more secondary outcomes

Other Outcomes (27)

  • Health practices

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

  • Mental health

    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

  • +24 more other outcomes

Study Arms (2)

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.

Behavioral: Mindfulness Training

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

Behavioral: Health Education

Interventions

Mindfulness TrainingBEHAVIORAL

Guided mindfulness meditation and stress management training

Mindfulness Training
Health EducationBEHAVIORAL

Guided health education and stress management training

Health Education

Eligibility Criteria

Age65 Years - 93 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center- Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (2)

  • 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.

    PMID: 37982547DERIVED

  • 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.

    PMID: 33657083DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Rebecca Pawlikowsky, BA

    Office of Sponsored Projects, Carnegie Mellon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2016

First Posted

September 5, 2016

Study Start

June 28, 2016

Primary Completion

February 21, 2020

Study Completion

November 29, 2020

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)