Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03693274|
Recruitment Status : Terminated (Principal investigator leaving institution.)
First Posted : October 2, 2018
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Fibromyalgia Central Sensitisation||Behavioral: BreathAware for Pain Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study|
|Actual Study Start Date :||January 2, 2019|
|Actual Primary Completion Date :||August 25, 2020|
|Actual Study Completion Date :||August 25, 2020|
Experimental: Mindfulness Course
Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center and will also be given access to BreatheAware for Pain Management, a 16- week web-based mindfulness course.
Behavioral: BreathAware for Pain Management
Patients will be given access to a BreathAware, a 16- week web-based mindfulness course, which will be initiated at their enrollment. BreathAware is a self-paced course comprised of 2-3 minute lessons delivered via video, audio and technology-based guided instruction, and is available on a phone or tablet.
No Intervention: Usual Care
Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center.
- Feasibility: Number of participants who complete the study [ Time Frame: 17 weeks ]Number of participants who complete the study
- Change in mean Five Facet Mindfulness Questionnaire (FFMQ) score [ Time Frame: Baseline and 17 weeks ]Comparison of mean score of FFMQ at baseline and 17 weeks of study participation. FFMQ is a self administered 39 item validated comprehensive instrument for assessing different aspects of mindfulness. Respondents rate statements according to how true the statement is to them on a scale of 1 (never or very rarely true) to 5 (very often or always true). Total scores are between 39 and 195 and higher scores indicate greater mindfulness.
- Change in median Patient Reported Outcomes Measurement Information Systems-29 (PROMIS_29) score [ Time Frame: Baseline and 17 weeks ]
Comparison of mean PROMIS-29 score at baseline and 17 weeks of study participation.
The PROMIS-29 (version 2) is a self administered validated instrument to assess seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. In addition, pain intensity is measured with a single item on an 11-point numeric scale (NPRS) that ranges from 0 to 10. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
- Change in Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline and 17 weeks ]Comparison of mean PCS score at baseline and 17 weeks of study participation. The PCS is measured with a self-administered questionnaire. The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
- Global Change [ Time Frame: 17 weeks ]Global change measured by Patient Global Impression of Change (PGIC). The PGIC evaluates aspects of patients health and assesses if there has been an improvement or decline. The patient reports change in activity limitations, symptoms, emotions, and overall quality of life on scale from 1 (No change) to 7 (a great deal better), and the degree of change on a scale from 0 (much better) to 10 (much worse).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693274
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Jenna Walters, MD||Vanderbilt University Medical Center|