MBSR for Pain Catastrophizing in SCD

Anemia, Sickle Cell Clinical Trial

Official title:

A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394587
• Other study ID #: Pro00052848
• Secondary ID: F31NR014954-01
• Status: Completed
• Phase: N/A
• First received: February 9, 2015
• Last updated: December 27, 2017
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

Behavioral:
• Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.

Locations

Country	Name	City	State
United States	Duke University School of Nursing	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of MBSR as measured by semi-scripted telephone assessments	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.	6 weeks
Primary	Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs	Feasibility of the intervention will be assessed by recruitment and attrition rates, number of daily mindfulness logs completed, and average number of weekly minutes of mindfulness practice as recorded in logs. Feasibility data will be obtained for both the intervention and control subjects who elect to receive the intervention after the intervention is complete with the MBSR group. However, data will not be analyzed together because the delay to receiving the intervention would affect the results. Data from the control group will be used to help inform future studies.	6 weeks
Secondary	Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale	Descriptive statistics will be used to summarize the pain catastrophizing at week1, 3, and 6, as measured by the Pain Catastrophizing Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing.	baseline, week 1, week 3, and week 6
Secondary	Change in Mindfulness as measured by the Mindful Attention Awareness Scale	Descriptive statistics will be used to summarize mindfulness at week1, 3, and 6, as measured by the Mindful Attention Awareness Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing.	baseline, week 1, week 3, and week 6