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NCT02394587 · ClinicalTrials.gov registry record · NA
MBSR for Pain Catastrophizing in SCD
A NA study of Anemia, Sickle Cell, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02394587: Completed NA study of Anemia, Sickle Cell, sponsored by Duke University.
NCT02394587 is a NA study of Anemia, Sickle Cell that has completed, run by Duke University. The registered enrollment target is 60 participants, below the 115-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02394587, a NA study of Anemia, Sickle Cell, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Significance: The purpose of this exploratory study is to test the feasibility, accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain catastrophizing is a negative mental state toward pain stimuli and pain experience, and is associated with increased pain severity, pain interference, and lower social functioning, physical functioning, and mental health. There have been no psychobehavioral intervention studies that have attempted to alter the experience of pain catastrophizing in persons with SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this highly significant problem for both SCD patients and providers. This project will be the first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve quality of life for SCD patients with chronic pain. 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 conditio
Primary Outcome
Acceptability of the intervention will be assessed by semi-scripted telephone or in-person interviews. The semi-scripted interview will focus on MBSR patients' reflections and expectations of the program, the mindfulness skills they found useful and in what ways, the skills they found less useful and or difficult to implement, and on any changes in thoughts or actions that resulted from the application of the MBSR techniques.
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-based Stress Reduction
Study Locations (1)
North Carolina
- Duke University School of Nursing - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT02394587 record still lists
NCT02394587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 115-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Anemia, Sickle Cell appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-based Stress Reduction is the first listed.
NCT02394587 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02394587 about?
NCT02394587 is a clinical study titled "MBSR for Pain Catastrophizing in SCD". Significance: The purpose of this exploratory study is to test the feasibility, accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the most difficult symptoms for SCD pa...
What is the current status of trial NCT02394587?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2015-04. Estimated completion is 2016-01.
What conditions does trial NCT02394587 study?
This clinical trial studies the following conditions: Anemia, Sickle Cell.
What interventions are being tested in trial NCT02394587?
The interventions under investigation include: Mindfulness-based Stress Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT02394587?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02394587 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anemia, Sickle Cell
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02394587's enrollment target sits among peer trials
60 11th of 17 higher than 7 of 17 other Anemia, Sickle Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia, Sickle Cell 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.
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