Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-04-30
2016-01-31
Brief Summary
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Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group. The MBSR group will complete a 6- week, group-based telephonic MBSR program that is administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility, acceptability, and effects on pain catastrophizing will be assessed by questionnaires at baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR participants will complete semi-scripted telephone interviews to help assess intervention acceptability, and the wait-listed control condition will be offered the same MBSR intervention.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Mindfulness-Based Stress Reduction
Subjects assigned to the experimental group will participate in a MBSR foundation program, which includes weekly telephonic, group-based, 60-minute MBSR sessions for 6 weeks. The foundation program will introduce subjects to the concept of mindfulness with each week focusing on a different facet. Modeled after Kabat-Zinn's original program, breath awareness (focus on breath and observing thoughts without fighting or following them), body scan (promoting mindfulness of sensations in different parts of body), walking meditation (walking as form of meditation), loving kindness (projection of friendliness and kindness towards oneself and others), and choiceness awareness (awareness of all sensations with equal interest) will be taught.
Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.
Wait-listed control group
Subjects assigned to the wait-listed control group will not receive the MBSR program, but will receive weekly reminders of their study participation, be asked to complete the same questionnaires (per telephone script) once every three weeks, and receive the same financial incentives as the MBSR group. Upon completion of the 6-week session, the wait-list control group will be offered the same MBSR program. At that time, a new series of MBSR sessions will be scheduled and offered to the wait-listed control patients. Subjects who elect to participate in MBSR will receive the same packet of materials and measures received by the intervention group and be asked to complete the measures again at baseline, 1, 3, and 6 weeks.
Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.
Interventions
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Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.
Eligibility Criteria
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Inclusion Criteria
2. Are \>age 21,
3. Self-identify (to the PI at baseline assessment) that they are experiencing chronic, non-cancer pain that has persisted on most days for more than 6 months, and adversely affects their function or well-being,
4. are able to speak and read English,
5. Have access to a telephone (or cell phone) in the home for the intervention and individual assessment interviews (data from the SCD clinic indicate 82% of patients have a cell phone),
6. Have access to a CD or mp3 player for homework assignments and daily practice,
7. Are available during the scheduled telephone intervention, and
8. Complete and return the baseline assessment
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Nursing Research (NINR)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Paula Tanabe, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University School of Nursing
Locations
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Duke University School of Nursing
Durham, North Carolina, United States
Countries
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References
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Williams H, Silva S, Simmons LA, Tanabe P. A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial. Trials. 2017 May 15;18(1):218. doi: 10.1186/s13063-017-1948-x.
Other Identifiers
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Pro00052848
Identifier Type: -
Identifier Source: org_study_id