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NCT01301105 · ClinicalTrials.gov registry record · NA
The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01301105: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT01301105 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01301105, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the investigators hypothesize that participants undergoing MBSR training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, decreased stress levels on a social stress test, decreased general psychosocial stress as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation of cellular aging, and different neural patterns in response to thermal pain and aversive visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI). To test these hypotheses, the study will recruit 50 participants through the UW-Madison Integrative Medicine Program. All participants will be randomly assigned either to an 8-week MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the study, participants will be invited to participate to the second class should they be interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI scanning, cortisol sampling, and blood sampling before training begins, after the first program ends, and again four months after the first program ends and prior to the second program. If hypotheses are supported, the study may benefit participants by reducing their psychological distress, increasing their well-being, and helping them better manage pain and aversive stimuli. There are no other direct benefits to participants. Potential risks associated with fMRI include ferromagnetic collision, neurostimulation effects, and psychological discomfort. Potential risks to subjects include slight potential discomfort in providing saliva samples, discomfort of painful thermal stimulation, stress associated with the Trier Social Stress Test,
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction (MBSR)
- BEHAVIORAL Health Enhancement Program (HEP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-04 |
| Phase | NA |
What the finished NCT01301105 record still lists
NCT01301105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction (MBSR) is the first listed.
NCT01301105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01301105 about?
NCT01301105 is a clinical study titled "The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress". The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR) on pain regulation, social stress, basic affective and attention functions, and on the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the investigators hypothesize that...
What is the current status of trial NCT01301105?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2005-10. Estimated completion is 2007-04.
What interventions are being tested in trial NCT01301105?
The interventions under investigation include: Mindfulness Based Stress Reduction (MBSR) (BEHAVIORAL), Health Enhancement Program (HEP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01301105?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01301105's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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