Clinical trial NCT02394587: MBSR for Pain Catastrophizing in SCD
Official title: A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia, Sickle Cell
Keywords: mindfulness
MBSR
SCD
experimental
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2015-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 condition will be offered the same MBSR intervention.


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent,
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:

* Patients will be excluded if they report previously studying MBSR, currently receiving mindfulness-based or cognitive behavioral therapies, or being regular practitioners of mindfulness, including yoga.

Primary outcomes:
measure: Acceptability of MBSR as measured by semi-scripted telephone assessments
timeFrame: 6 weeks
measure: Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale
timeFrame: baseline, week 1, week 3, and week 6
measure: Change in Mindfulness as measured by the Mindful Attention Awareness Scale
timeFrame: baseline, week 1, week 3, and week 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Nursing
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.