Anemia, Sickle Cell Clinical Trial
Official title:
A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease
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 condition will be offered the same MBSR
intervention.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06078696 -
Siplizumab for Sickle Cell Disease Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
Completed |
NCT02561312 -
Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell
|
||
Completed |
NCT00890396 -
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)
|
||
Completed |
NCT00059293 -
Transcranial Doppler (TCD) Ultrasound of Subjects Enrolled in BABY HUG - Ancillary to BABY HUG
|
||
Terminated |
NCT00034528 -
Stem Cell Transplantation After Reduced-Dose Chemotherapy for Patients With Sickle Cell Disease or Thalassemia
|
Phase 2 | |
Completed |
NCT00005277 -
Cooperative Study of The Clinical Course of Sickle Cell Disease
|
N/A | |
Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
Completed |
NCT04584528 -
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
|
N/A | |
Recruiting |
NCT02286154 -
Therapeutic Response Evaluation and Adherence Trial (TREAT)
|
N/A | |
Completed |
NCT02857023 -
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
|
N/A | |
Withdrawn |
NCT01925001 -
Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis
|
Phase 2 | |
Terminated |
NCT00122980 -
Stroke With Transfusions Changing to Hydroxyurea
|
Phase 3 | |
Completed |
NCT00246077 -
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport
|
N/A | |
Completed |
NCT00094887 -
Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
|
Phase 2 | |
Completed |
NCT00035763 -
Pain in Sickle Cell Epidemiologic Study
|
N/A | |
Terminated |
NCT04091737 -
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease
|
Phase 1 | |
Completed |
NCT00005300 -
Investigation of Selected Patient Groups From The Cooperative Study of Sickle Cell Disease
|
N/A | |
Recruiting |
NCT04351698 -
SMILES: Study of Montelukast in Sickle Cell Disease
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06290401 -
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
|
Phase 2 |