Mindfulness based stress reduction program
Behavioral8-week mindfulness based stress reduction program
NCT Number: NCT00594243
This pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone (see appendix for checklist). Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized in blocks of six using a simple randomization process with no stratification using a table of random numbers. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37 participants have been recruited into the study to do the intervention, the intervention will be done on a rolling basis. This means there will be a minimum of 6 participants per intervention group, with the possibility of three separate intervention groups. If recruitment goes better than expected, then we will offer the intervention to all 18 participants at one time. Controls will not receive any intervention during this time. Immediately post-intervention the measures will be administered again to participants and wait-list controls. Once the intervention is complete and participants and wait-list controls have completed post-intervention measures the mindfulness meditation program will be offered to the wait-list controls. We will try to combine the wait-list controls into one eight-week program. 3 months after the intervention is completed, participants will be asked to complete the measures a third time and any mindfulness meditation they continue to do at home will be quantified.
The primary hypotheses are:
1. We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period. 2. We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions. 3. We expect mindfulness meditation will result in a moderate effect size difference (0.5) between the intervention participants and wait-list control participants on outcome measures of pain, mood, physical function, attention, and QOL.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Phase 2 / Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants will be included if they are:
Exclusion criteria
They will be excluded if they:
8-week mindfulness based stress reduction program
No treatment given.
University of Pittsburgh
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07727525
Back Pain, Chronic Low Back Pain
Rawalpindi, Punjab Province, Pakistan
View Trial DetailsNCT07694219
Back Pain, Chronic Low Back Pain
Lahore, Pakistan
View Trial DetailsNCT04678297
Behavior, Chronic Low Back Pain
Storrs Mansfield, Connecticut, United States
View Trial DetailsNCT00887003
Chronic Low Back Pain
Hamilton, Ontario, Canada
View Trial Details