A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease
MBSR for Pain Catastrophizing in SCD
Sponsors
Lead Sponsor
Collaborators
Source
Duke University
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2015-04-01
Completion Date
2016-01-01
Primary Completion Date
2016-01-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Acceptability of MBSR as measured by semi-scripted telephone assessments |
6 weeks |
|
Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs |
6 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale |
baseline, week 1, week 3, and week 6 |
|
Change in Mindfulness as measured by the Mindful Attention Awareness Scale |
baseline, week 1, week 3, and week 6 |
Enrollment
60
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
A non-pharmacological approach to pain management.
Arm Group Label
Mindfulness-Based Stress Reduction
Wait-listed control group
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Paula Tanabe, PhD |
Principal Investigator |
Duke University School of Nursing |
Location
Facility |
|
Duke University School of Nursing Durham North Carolina 27701 United States |
Location Countries
Country
United States
Verification Date
2017-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
F31NR014954-01
Number Of Arms
2
Arm Group
Arm Group Label
Mindfulness-Based Stress Reduction
Arm Group Type
Experimental
Description
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.
Arm Group Label
Wait-listed control group
Arm Group Type
Other
Description
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.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
February 9, 2015
Study First Submitted Qc
March 19, 2015
Study First Posted
March 20, 2015
Last Update Submitted
December 27, 2017
Last Update Submitted Qc
December 27, 2017
Last Update Posted
December 29, 2017
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.