Anemia, Sickle CellNCT02394587
MBSR for Pain Catastrophizing in SCD
A study testing Mindfulness-based Stress Reduction in people with Anemia, Sickle Cell, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- Mindfulness-based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent,
- Are >age 21,
- 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,
- are able to speak and read English,
- 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),
- Have access to a CD or mp3 player for homework assignments and daily practice,
- Are available during the scheduled telephone intervention, and
- Complete and return the baseline assessment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
Durham, North Carolina, 27701
About this study
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.
- Conditions
- Anemia, Sickle Cell
- Being tested
- Mindfulness-based Stress Reduction
- Keywords
- mindfulness, MBSR, SCD, experimental
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress ReductionBehavioural
A non-pharmacological approach to pain management.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 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. Receives: Behavioral: Mindfulness-based Stress Reduction |
| Wait-listed control group | Other | 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. Receives: Behavioral: Mindfulness-based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: baseline, week 1, week 3, and week 6
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.
Measured: baseline, week 1, week 3, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394587
- Sponsor's protocol ID
- Pro00052848
- Other IDs
- F31NR014954-01
- Status last verified
- Apr 2017
- First submitted
- 9 Feb 2015
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28506281
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02394587
- Acronym / sponsor ID
- Pro00052848
- Conditions
- Anemia, Sickle Cell
- Keywords
- mindfulness, MBSR, SCD, experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-based Stress ReductionSubjects 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. |
| Wait-listed control group | Other | Behavioral: Mindfulness-based Stress ReductionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent,
- Are >age 21,
- 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,
- are able to speak and read English,
- 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),
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress ReductionA non-pharmacological approach to pain management. | Behavioural | Mindfulness-Based Stress Reduction, Wait-listed control group |
Primary outcome
Acceptability of MBSR as measured by semi-scripted telephone assessments
Time frame: 6 weeks
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.
Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs
Time frame: 6 weeks
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.
2 secondary outcomes
Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale
Time frame: baseline, week 1, week 3, and week 6
Change in Mindfulness as measured by the Mindful Attention Awareness Scale
Time frame: baseline, week 1, week 3, and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Derived from this study: PubMed 28506281Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Tanabe, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction in people with Anemia, Sickle Cell, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of MBSR as measured by semi-scripted telephone assessments (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.