Psychological StressNCT02888600
Stress Management Training for Healthy Aging
A study testing Mindfulness Training and Health Education in people with Psychological Stress and Loneliness, run by Carnegie Mellon University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 93 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Loneliness
- What is being tested?
- Mindfulness Training and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2016to 29 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 93 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- English speaking
Who cannot join
- [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center- Center for Integrative Medicine
Pittsburgh, Pennsylvania, 15232
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
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.
Read the detailed 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.
- Conditions
- Psychological Stress, Loneliness
- Being tested
- Mindfulness Training, Health Education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Guided mindfulness meditation and stress management training
Health EducationBehavioural
Guided health education and stress management training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating markers of inflammation, Interleukin-6 and C Reactive Protein
Measured via blood samples
Measured: Change from baseline to 1-week post-intervention and 3-month follow-up
Secondary outcomes (6)
Pro-inflammatory gene expression
Measured: Change from baseline to 1-week post-intervention
Self-reported relational distress
Evaluated using ecological momentary assessment
Measured: Change from Baseline to Intervention Weeks 4 and 8
Self-reported loneliness
Evaluated using UCLA loneliness scale and ecological momentary assessment
Measured: 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
Measured: 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
Measured: 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
Measured: 1-week post-intervention and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start28 Jun 2016
- Primary completion21 Feb 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Virginia Commonwealth University
- Responsible party
- Principal investigator, David Creswell, Carnegie Mellon University
- Investigators
- Rebecca Pawlikowsky, BA, Study chair, Office of Sponsored Projects, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888600
- Sponsor's protocol ID
- 1R01AT008685-01
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2016
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37982547Lindsay 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.
PubMed 33657083
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Training for Healthy Aging
- ClinicalTrials.gov ID
- NCT02888600
- Acronym / sponsor ID
- 1R01AT008685-01
- Conditions
- Psychological Stress, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Virginia Commonwealth University
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Active comparator | Behavioral: Mindfulness TrainingThe 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 | Behavioral: Health EducationThe 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 |
Who may qualify
- Ages
- 65 to 93 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- English speaking
Key exclusion criteria (1 listed)
- [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingGuided mindfulness meditation and stress management training | Behavioural | Mindfulness Training |
| Health EducationGuided health education and stress management training | Behavioural | Health Education |
Primary outcome
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
6 secondary outcomes
Pro-inflammatory gene expression
Time frame: Change from baseline to 1-week post-intervention
Self-reported relational distress
Time frame: Change from Baseline to Intervention Weeks 4 and 8
Self-reported loneliness
Time frame: 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
Time frame: 1-week post-intervention and 3-month follow-up
Working memory in daily living
Time frame: Change from baseline to intervention weeks 4 and 8
Implicit acceptance of self
Time frame: 1-week post-intervention and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 37982547Lindsay 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.
- Derived from this study: PubMed 33657083Lindsay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Pawlikowsky, BA study chair
Office of Sponsored Projects, Carnegie Mellon University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Health Education in people with Psychological Stress and Loneliness, run by Carnegie Mellon University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.