PsychologicalNCT04304664
Mindfulness- Based Intervention for Fibromyalgia Patients
A study testing Mindfulness- Based Intervention in people with Psychological, run by Bar-Ilan University, Israel at 2 sites in Israel.
Trial summary
Fibromyalgia is a chronic pain syndrome, often involves high levels of depression, anxiety and cognitive deficits (e.g., "Fibro Fog"). Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological
- What is being tested?
- Mindfulness- Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesIsrael
- Study dates
- 23 Jan 2017to 8 Sep 2018
- 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
- confirmation of a clinical diagnosis of Lupus by the patient's own physician
- age 18 years or older
- Hebrew speakers
- physical ability to attend group intervention sessions
- psychological ability to practice mindfulness (no cognitive extreme impairments, no psychosis, no suicidal tendencies)
Who cannot join
- serious mental health condition (such as suicidal state, alcohol and drug abuse, schizophrenia)
- serious physical condition that would not enable participation
- participation in another study.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Chaim Sheba Medical Center
Ramat Gan, 52621
Bar- Ilan University
Ramat Gan, 5290002
About this study
Official title: The Efficacy of Mindfulness- Based Intervention for Fibromyalgia Patients: a Randomized Control Trial
Fibromyalgia is a chronic pain syndrome, often involves high levels of depression, anxiety and cognitive deficits (e.g., "Fibro Fog"). Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease.
Nevertheless, not much is known about the efficiency of MBI among fibromyalgia patients and about the mechanisms of change through which MBI works.
Read more
In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action.
The study is a randomized-controlled trial. 95 Patients diagnosed with fibromyalgia (Mean age=52) were randomly assigned to either a 10-weeks MBI intervention (N=49) or a waitlist-control (WL;N=46). 4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.
Read the detailed description
Fibromyalgia Fibromyalgia is a frequently diagnosed pain disorder primarily affecting women and showing high comorbidity with other functional somatic disorders, stress and depression. It is characterized by chronic and widespread skeletal muscle pain, such as chronic headaches, sore throats, visceral pain, and sensory hyper- responsiveness accompanied by a wide variety of symptoms, with no obvious tissue pathology. Aside from the pain, which is the main known feature of the condition, people with fibromyalgia often experience higher levels of fatigue, sleep disturbances, memory deficits, and mood difficulties. Research examining cognitive mechanisms involved in fibromyalgia, found an impaired working memory and functioning in everyday attentional tasks, even after controlling for mood and sleep disruption.
Mindfulness Mindfulness involves 'paying attention in a particular way: on purpose, in the present moment, and nonjudgmentally'. It refers to the cultivation of conscious awareness and attention on a moment-to-moment basis. The quality of awareness sought by mindfulness practice includes openness or receptiveness, curiosity and a non-judgmental attitude. An emphasis is placed on seeing and accepting things as they are without trying to change them. With its emphasis on acceptance of body sensations, it should come as no surprise that mindfulness was found to be effective in treating a variety of medical conditions, where distress often stems from the intrusive nature of the pain and difficulties in daily functioning Mindfulness-based stress reduction (MBSR) MBSR is a mindfulness- based intervention, developed at the University of Massachusetts Medical Center in 1979 as an intervention to relieve stress and better cope with illness, and it is now being offered at many health care institutions in the US and Europe. In its original version, MBSR is an eight-week program in mindfulness training. The standard program has weekly group sessions of 2 - 2.5 hours and one all-day session after six to seven weeks. The weekly sessions have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment.
MBSR interventions have been studied among patients with fibromyalgia, but not enough is known about its specific effects, and no research to date has explored the cognitive mechanisms of change trough which mindfulness intervention operates, among chronic pain patients, where cognitive impairment constitutes a dominant part of the condition. Additionally, Recent years have seen a surge in research supporting personalized treatment, "tailored" to the individual patient's size. Various studies have shown a significant interaction between specific patient characteristics and treatment outcome. Nonetheless, most research in the field of Mindfulness have used the standard protocol of MBSR, without considering the specific need and difficulties of fibromyalgia patient, both psychological and physical (e.g., sitting down through a long meditation). In the current study, the investigators plan to answer this gap, and develop a protocol of MBI (mindfulness- based intervention) based on the generic MBSR protocol, which would be adapted to the specific needs of fibromyalgia patients.
The main objective of this study is to explore the impact of MBI on fibromyalgia patients. Since fibromyalgia is a stress-related conditions, which is maintained and worsened by stress, the investigators believe that an intervention which focuses on stress- reduction, such as MBI, would be very beneficial for the condition, and that the reduction in stress would mediate an improvement in physiological aspects (e.g., pain), psychological aspects (e.g., depression and anxiety) and cognitive aspects (e.g., control of pain and body awareness) of the conditions as well.
Recent years have seen a surge in research supporting personalized treatment, "tailored" to the individual patient's size. Various studies have shown a significant interaction between specific patient characteristics and treatment outcome.
In this study, the investigators will examine how potential cognitive (e.g., psychological flexibility towards pain, pain catasrophizing), psychopathological (e.g., baseline stress and depression) and physiological (e.g., baseline Fibromyalgia symptoms) moderators of MBI action.
In this study, for the first time ever, the investigators explore an amended MBSR protocol, which has been tailored specifically to address the unique and exclusive necessities and adversities of fibromyalgia patients, such as pain and the cognitive psychological aspects of the pain. This examination is highly supported by the approach of personalized medicine, which has significantly developed over the last decades, advocating the creation of customized treatment, which is "tailored" to the patient's size.
the investigators expect that MBI would lead to greater improvements in clinical symptoms (such as depression and anxiety), decrease pain levels and enhance cognitive processes such as psychological flexibility, compared to a waiting list control group.
Consequently, the investigators assume that the expected reduction in symptoms, would be mediated by cognitive variables, namely, a positive change in cognitive variable, in turn, will lead to positive changes in psychological and physiological symptoms.
Methods The current study is a randomized- Control Trial (RCT), 119 patients diagnosed with fibromyalgia syndrome were randomly assigned either to mindfulness-based intervention group (MBI) or to a wait-list control group (WL).
MBI group Treatment participants received MBI, specially adapted to treat fibromyalgia patients by a group of mindfulness specialist psychologists and therapists, with experience treating fibromyalgia patients. The intervention led by a licensed clinical therapist and mindfulness specialist, who was trained in MBSR at Bangor University.
The intervention took place in Chaim Sheba medical Center and lasted 10 weeks, with one session a week.
the investigators conducted 3 measurements points through the intervention, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). Additionally, the investigators conducted blood tests before and after the intervention (T1 and T3).
In addition to the quantitative date, the investigators carried out qualitative interviews. the investigators wanted to examine the experience of the participants in the intervention in their own words. The aims of the interviews were to explore participants' subjective experiences in their own words, to acquire a deeper understand of the changes in psychological aspects and to analyze the underlying mechanisms of psychological changes. Furthermore, the investigators wanted to comprehend the specific needs of SLE patients might be better addressed within the adapted protocol.
Last, blood tests were conducted before and after the intervention (T1 and T3), in order to examine blood related measures, including a c-reactive protein test (CRP), erythrocyte sedimentation rate, complement C3 and C4, cytokines, antibodies and Complete Blood Count (CBC).
Wait-list (WL) control group Patients randomized to this group received no active treatment during their 10-weeks waiting period, and in the end of that period received the exact intervention as the study group.
- Conditions
- Psychological
- Being tested
- Mindfulness- Based Intervention
- Keywords
- Mindfulness, Fibromyalgia, Mindfulness- Based Intervention (MBI), Stress- Related disease
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness- Based InterventionOther
Mindfulness- Based Intervention in a psychological intervention, based on mind- body connection.
The protocol includes a 10- weeks program, with weekly group sessions of 2 hours and one all-day session after seven weeks. The intervention have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness- Based Intervention (MBI) | Experimental | In MBI arm, patients received mindfulness- based intervention, a psychological mind- body intervention, focusing on stress reduction,. the intervention was led by a licensed clinical therapist and mindfulness specialist, who was trained in MBSR at Bangor University. Receives: Other: Mindfulness- Based Intervention |
| Wait- List Controls (WL) | No intervention | Patients in wait- list control arm received no active treatment during their 10-weeks waiting period. At the end of that period received the exact intervention as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIQR (Fibromyalgia impact questionnaire revised)
Fibromyalgia impact was measured by the Revised Fibromyalgia Impact Questionnaire (FIQR). The FIQR is 21-item self-report instrument that assesses fibromyalgia severity (impact) over the past seven days. The FIQR is scored as a total score calculated from three subscales: physical function, overall well-being, and symptoms. It is scored from 0 to 100 with higher scores indicating a more negative impact of fibromyalgia. It has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change.
Measured: Through study completion, an average of 9 month
PSS (Perceived Stress Scale)
A widely-used and well-validated 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress. The PSS was often found to possess very good psychometric properties.
Measured: Through study completion, an average of 9 month
PHQ-9 (The Patient Health Questionnaire-9 )
PHQ-9 is a self-administered questionnaire used to assess major depression symptoms, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It can yield either a continuous score, or a probable major depressive disorder diagnosis using a cut-off of 10. The sensitivity and specificity of the PHQ-9 compare favorably with structured psychiatric interviews and the Cronbach alpha was found to be 0.89 in a sample of primary care patients.
Measured: Through study completion, an average of 9 month
FFMQ (Five Facet Mindfulness Questionnaire)
FFMQ derived from a factor analysis of questionnaires measuring a trait-like general tendency to be mindful in daily life. It yield five scoring scales that appear to represent elements of mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non- reactivity to inner experience. FFMQ consists of 39 items, items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ has been shown to have good internal consistency and significant relationships in the predicted directions with a variety of constructs related to mindfulness.
Measured: Through study completion, an average of 9 month
PIPS (Psychological Inflexibility in Pain Scale)
PIPS is a 12-item scale developed to assess target variables in exposure and acceptance-oriented treatments of chronic pain ("I postpone things because of my pain"). The subscales measure avoidance (eight items) and cognitive fusion (four items). Items can be answered on a 7-point Likert scale (1=never true to 7=always true). The total score ranges from 12 to 84 points. Higher scores indicate greater psychological inflexibility. Studies showed good model fit and internal consistencies.
Measured: Through study completion, an average of 9 month
PCS (The pain catastrophizing scale)
The PCS is a self-administered questionnaire that consists of 13 items to assess the extent of the patient's catastrophizing thoughts and behaviors. It comprises three subscales: helplessness, magnification, and rumination. The questionnaire is completed in relation to the patient's thoughts and feelings when they are in pain. The scores for the subscales are given by the sum of the corresponding items, and the total score is computed by summation of all items. The PCS score ranges from 0 to 52 points.
Measured: Through study completion, an average of 9 month
EQ (Experiences Questionnaire)
EQ is a 20-item self-report scale measuring decentering, in which participants rate items on a 7-point Likert-type scale (1 = never to 7 = all the time). It evaluates an individual's ability to decenter, namely, the ability to regard thoughts and feelings as temporary and transient. The EQ focuses on three facets of decentering: the ability to view one's self as separate from one's thoughts, the ability to non-judgmentally observe one's negative experiences without habitually reacting, and the capacity for self-compassion. Multiple studies have demonstrated sound psychometric properties of the EQ.
Measured: Through study completion, an average of 9 month
BAI (The Beck Anxiety Inventory)
BAI is a 21-item questionnaire that measures cognitive and somatic symptoms of anxiety, with higher scores indicating increased anxiety, (range 0-63). Sample items include "unable to relax" and "heart pounding or racing." Good psychometric properties have been demonstrated among college, medical, and psychiatric samples. The BAI is a 21-item scale that measures cognitive, somatic, and affective symptoms of anxiety.
Measured: Through study completion, an average of 9 month
BAQ (Body awareness questionnaire)
The 18-item Body Awareness Questionnaire assessed reported attentiveness to normal non-emotive body processes, sensitivity to body cycles/rhythms, ability to detect small changes in normal functioning, and to anticipate bodily reactions ("I am aware of a cycle in my activity level throughout the day", and "I notice specific bodily reactions to being over hungry"). It is a 7-point Likert-type scale (1 = Not at all true of me to 7 = Very true of me). Studies reported good reliability and validity of the BAQ. The total score ranges from 18 to 126 points. Higher scores indicate greater body awareness.
Measured: Through study completion, an average of 9 month
The WHOQOL-BREF (The World Health Organization Quality of Life)
WHOQOL is an abbreviated 26-item version of the WHOQOL-100, on a scale of 1-5. It contains one general QOL item, one general health item, and 24 specific items-one item from each of the 24 QOL facets of the WHOQOL-100. The 24 specific items cover four broad domains: physical, psychological, social, and environmental quality of life. The items are answered on five-point scales, which assess the intensity, capacity, frequency, and evaluation of QOL facets with respect to the last two weeks. Negatively keyed items are reversely scored, so that higher values indicate better QOL.
Measured: Through study completion, an average of 9 month
VAS Pain (Visual Analog Scale for Pain)
The VAS pain is a self- report measure continuous scale, comprised of a horizontal line ranged of 0-100. VAS was based on 3 single- item continuous scale, for pain intensity, shame in one's disease and the third measured the levels of how much the disease has taken over the patients identity. The VAS is the most commonly used measure for assessing levels of pain by physicians in medical setting.
Measured: Through study completion, an average of 9 month
DAI-10 (Drug Attitude Inventory)
The DAI includes a series of 10 questions, each with true/false answers, regarding the adherent of patients to their prescribed medication, and pertaining to various aspects of the patient's perceptions and experiences of treatment. The original scale consists of 30 questions, but a short form consisting of 10 questions has also been validated.
Measured: Through study completion, an average of 9 month
Home Practice Diary
In order to comprehensively assess mindfulness practice at home, participants would fill out a daily home practice diary, which will include the date, time, type, and duration of both formal and informal mindfulness home practice, along with any comments on their experience. This home practice form is commonly used in MBSR interventions.
Measured: Through study completion, an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start23 Jan 2017
- Primary completion4 Sep 2018
- Study completion8 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study is a randomized- Control Trial (RCT), 95 patients diagnosed with fibromyalgia syndrome were randomly assigned either to mindfulness-based intervention group (MBI) or to a wait-list control group (WL).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Danny Horesh, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304664
- Sponsor's protocol ID
- 251120192
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD would be available to other researchers, including Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report and Analytic Code through e- mail or publications.
Publications
Adams SG Jr, Dammers PM, Saia TL, Brantley PJ, Gaydos GR. Stress, depression, and anxiety predict average symptom severity and daily symptom fluctuation in systemic lupus erythematosus. J Behav Med. 1994 Oct;17(5):459-77. doi: 10.1007/BF01857920.
PubMed 7877156Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.
PubMed 19369473Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
PubMed 19664287Carson JW, Carson KM, Jones KD, Mist SD, Bennett RM. Follow-up of yoga of awareness for fibromyalgia: results at 3 months and replication in the wait-list group. Clin J Pain. 2012 Nov-Dec;28(9):804-13. doi: 10.1097/AJP.0b013e31824549b5.
PubMed 22751025Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
PubMed 24737367Emmelkamp, P. M., Bouman, T. K., & Blaauw, E. (1994). Individualized versus standardized therapy: A comparative evaluation with obsessive-compulsive patients. Clinical Psychology & Psychotherapy, 1(2), 95-100.
Emori A, Matsushima E, Aihara O, Ohta K, Koike R, Miyasaka N, Kato M. Cognitive dysfunction in systemic lupus erythematosus. Psychiatry Clin Neurosci. 2005 Oct;59(5):584-9. doi: 10.1111/j.1440-1819.2005.01418.x.
PubMed 16194262Ferrari R. A cohort-controlled trial of the addition of customized foot orthotics to standard care in fibromyalgia. Clin Rheumatol. 2012 Jul;31(7):1041-5. doi: 10.1007/s10067-012-1966-8. Epub 2012 Mar 20.
PubMed 22426704Glass JM. Review of cognitive dysfunction in fibromyalgia: a convergence on working memory and attentional control impairments. Rheum Dis Clin North Am. 2009 May;35(2):299-311. doi: 10.1016/j.rdc.2009.06.002.
PubMed 19647144Hamburg MA, Collins FS. The path to personalized medicine. N Engl J Med. 2010 Jul 22;363(4):301-4. doi: 10.1056/NEJMp1006304. Epub 2010 Jun 15. No abstract available.
PubMed 20551152Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
PubMed 19034715Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
PubMed 7042457Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
PubMed 3897551Karlson EW, Daltroy LH, Rivest C, Ramsey-Goldman R, Wright EA, Partridge AJ, Liang MH, Fortin PR. Validation of a Systemic Lupus Activity Questionnaire (SLAQ) for population studies. Lupus. 2003;12(4):280-6. doi: 10.1191/0961203303lu332oa.
PubMed 12729051Liang MH, Socher SA, Larson MG, Schur PH. Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum. 1989 Sep;32(9):1107-18. doi: 10.1002/anr.1780320909.
PubMed 2775320
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mindfulness- Based Intervention for Fibromyalgia Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04304664
- Acronym / sponsor ID
- 251120192
- Conditions
- Psychological
- Keywords
- Mindfulness, Fibromyalgia, Mindfulness- Based Intervention (MBI), Stress- Related disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 8 Sep 2018 (actual)
- First posted
- 11 Mar 2020 (actual)
- 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.
Fibromyalgia is a chronic pain syndrome, often involves high levels of depression, anxiety and cognitive deficits (e.g., "Fibro Fog"). Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease.
Nevertheless, not much is known about the efficiency of MBI among fibromyalgia patients and about the mechanisms of change through which MBI works.
In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action.
The study is a randomized-controlled trial. 95 Patients diagnosed with fibromyalgia (Mean age=52) were randomly assigned to either a 10-weeks MBI intervention (N=49) or a waitlist-control (WL;N=46). 4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.
Detailed description
Fibromyalgia Fibromyalgia is a frequently diagnosed pain disorder primarily affecting women and showing high comorbidity with other functional somatic disorders, stress and depression. It is characterized by chronic and widespread skeletal muscle pain, such as chronic headaches, sore throats, visceral pain, and sensory hyper- responsiveness accompanied by a wide variety of symptoms, with no obvious tissue pathology. Aside from the pain, which is the main known feature of the condition, people with fibromyalgia often experience higher levels of fatigue, sleep disturbances, memory deficits, and mood difficulties. Research examining cognitive mechanisms involved in fibromyalgia, found an impaired working memory and functioning in everyday attentional tasks, even after controlling for mood and sleep disruption.
Mindfulness Mindfulness involves 'paying attention in a particular way: on purpose, in the present moment, and nonjudgmentally'. It refers to the cultivation of conscious awareness and attention on a moment-to-moment basis. The quality of awareness sought by mindfulness practice includes openness or receptiveness, curiosity and a non-judgmental attitude. An emphasis is placed on seeing and accepting things as they are without trying to change them. With its emphasis on acceptance of body sensations, it should come as no surprise that mindfulness was found to be effective in treating a variety of medical conditions, where distress often stems from the intrusive nature of the pain and difficulties in daily functioning Mindfulness-based stress reduction (MBSR) MBSR is a mindfulness- based intervention, developed at the University of Massachusetts Medical Center in 1979 as an intervention to relieve stress and better cope with illness, and it is now being offered at many health care institutions in the US and Europe. In its original version, MBSR is an eight-week program in mindfulness training. The standard program has weekly group sessions of 2 - 2.5 hours and one all-day session after six to seven weeks. The weekly sessions have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment.
MBSR interventions have been studied among patients with fibromyalgia, but not enough is known about its specific effects, and no research to date has explored the cognitive mechanisms of change trough which mindfulness intervention operates, among chronic pain patients, where cognitive impairment constitutes a dominant part of the condition. Additionally, Recent years have seen a surge in research supporting personalized treatment, "tailored" to the individual patient's size. Various studies have shown a significant interaction between specific patient characteristics and treatment outcome. Nonetheless, most research in the field of Mindfulness have used the standard protocol of MBSR, without considering the specific need and difficulties of fibromyalgia patient, both psychological and physical (e.g., sitting down through a long meditation). In the current study, the investigators plan to answer this gap, and develop a protocol of MBI (mindfulness- based intervention) based on the generic MBSR protocol, which would be adapted to the specific needs of fibromyalgia patients.
The main objective of this study is to explore the impact of MBI on fibromyalgia patients. Since fibromyalgia is a stress-related conditions, which is maintained and worsened by stress, the investigators believe that an intervention which focuses on stress- reduction, such as MBI, would be very beneficial for the condition, and that the reduction in stress would mediate an improvement in physiological aspects (e.g., pain), psychological aspects (e.g., depression and anxiety) and cognitive aspects (e.g., control of pain and body awareness) of the conditions as well.
Recent years have seen a surge in research supporting personalized treatment, "tailored" to the individual patient's size. Various studies have shown a significant interaction between specific patient characteristics and treatment outcome.
In this study, the investigators will examine how potential cognitive (e.g., psychological flexibility towards pain, pain catasrophizing), psychopathological (e.g., baseline stress and depression) and physiological (e.g., baseline Fibromyalgia symptoms) moderators of MBI action.
In this study, for the first time ever, the investigators explore an amended MBSR protocol, which has been tailored specifically to address the unique and exclusive necessities and adversities of fibromyalgia patients, such as pain and the cognitive psychological aspects of the pain. This examination is highly supported by the approach of personalized medicine, which has significantly developed over the last decades, advocating the creation of customized treatment, which is "tailored" to the patient's size.
the investigators expect that MBI would lead to greater improvements in clinical symptoms (such as depression and anxiety), decrease pain levels and enhance cognitive processes such as psychological flexibility, compared to a waiting list control group.
Consequently, the investigators assume that the expected reduction in symptoms, would be mediated by cognitive variables, namely, a positive change in cognitive variable, in turn, will lead to positive changes in psychological and physiological symptoms.
Methods The current study is a randomized- Control Trial (RCT), 119 patients diagnosed with fibromyalgia syndrome were randomly assigned either to mindfulness-based intervention group (MBI) or to a wait-list control group (WL).
MBI group Treatment participants received MBI, specially adapted to treat fibromyalgia patients by a group of mindfulness specialist psychologists and therapists, with experience treating fibromyalgia patients. The intervention led by a licensed clinical therapist and mindfulness specialist, who was trained in MBSR at Bangor University.
The intervention took place in Chaim Sheba medical Center and lasted 10 weeks, with one session a week.
the investigators conducted 3 measurements points through the intervention, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). Additionally, the investigators conducted blood tests before and after the intervention (T1 and T3).
In addition to the quantitative date, the investigators carried out qualitative interviews. the investigators wanted to examine the experience of the participants in the intervention in their own words. The aims of the interviews were to explore participants' subjective experiences in their own words, to acquire a deeper understand of the changes in psychological aspects and to analyze the underlying mechanisms of psychological changes. Furthermore, the investigators wanted to comprehend the specific needs of SLE patients might be better addressed within the adapted protocol.
Last, blood tests were conducted before and after the intervention (T1 and T3), in order to examine blood related measures, including a c-reactive protein test (CRP), erythrocyte sedimentation rate, complement C3 and C4, cytokines, antibodies and Complete Blood Count (CBC).
Wait-list (WL) control group Patients randomized to this group received no active treatment during their 10-weeks waiting period, and in the end of that period received the exact intervention as the study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The current study is a randomized- Control Trial (RCT), 95 patients diagnosed with fibromyalgia syndrome were randomly assigned either to mindfulness-based intervention group (MBI) or to a wait-list control group (WL).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness- Based Intervention (MBI) | Experimental | Other: Mindfulness- Based InterventionIn MBI arm, patients received mindfulness- based intervention, a psychological mind- body intervention, focusing on stress reduction,. the intervention was led by a licensed clinical therapist and mindfulness specialist, who was trained in MBSR at Bangor University. |
| Wait- List Controls (WL) | No intervention | –Patients in wait- list control arm received no active treatment during their 10-weeks waiting period. At the end of that period received the exact intervention as the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- confirmation of a clinical diagnosis of Lupus by the patient's own physician
- age 18 years or older
- Hebrew speakers
- physical ability to attend group intervention sessions
- psychological ability to practice mindfulness (no cognitive extreme impairments, no psychosis, no suicidal tendencies)
Key exclusion criteria (3 listed)
- serious mental health condition (such as suicidal state, alcohol and drug abuse, schizophrenia)
- serious physical condition that would not enable participation
- participation in another study.
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 InterventionMindfulness- Based Intervention in a psychological intervention, based on mind- body connection. The protocol includes a 10- weeks program, with weekly group sessions of 2 hours and one all-day session after seven weeks. The intervention have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment. | Other | Mindfulness- Based Intervention (MBI) |
Primary outcome
FIQR (Fibromyalgia impact questionnaire revised)
Time frame: Through study completion, an average of 9 month
Fibromyalgia impact was measured by the Revised Fibromyalgia Impact Questionnaire (FIQR). The FIQR is 21-item self-report instrument that assesses fibromyalgia severity (impact) over the past seven days. The FIQR is scored as a total score calculated from three subscales: physical function, overall well-being, and symptoms. It is scored from 0 to 100 with higher scores indicating a more negative impact of fibromyalgia. It has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change.
PSS (Perceived Stress Scale)
Time frame: Through study completion, an average of 9 month
A widely-used and well-validated 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress. The PSS was often found to possess very good psychometric properties.
PHQ-9 (The Patient Health Questionnaire-9 )
Time frame: Through study completion, an average of 9 month
PHQ-9 is a self-administered questionnaire used to assess major depression symptoms, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It can yield either a continuous score, or a probable major depressive disorder diagnosis using a cut-off of 10. The sensitivity and specificity of the PHQ-9 compare favorably with structured psychiatric interviews and the Cronbach alpha was found to be 0.89 in a sample of primary care patients.
FFMQ (Five Facet Mindfulness Questionnaire)
Time frame: Through study completion, an average of 9 month
FFMQ derived from a factor analysis of questionnaires measuring a trait-like general tendency to be mindful in daily life. It yield five scoring scales that appear to represent elements of mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non- reactivity to inner experience. FFMQ consists of 39 items, items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ has been shown to have good internal consistency and significant relationships in the predicted directions with a variety of constructs related to mindfulness.
PIPS (Psychological Inflexibility in Pain Scale)
Time frame: Through study completion, an average of 9 month
PIPS is a 12-item scale developed to assess target variables in exposure and acceptance-oriented treatments of chronic pain ("I postpone things because of my pain"). The subscales measure avoidance (eight items) and cognitive fusion (four items). Items can be answered on a 7-point Likert scale (1=never true to 7=always true). The total score ranges from 12 to 84 points. Higher scores indicate greater psychological inflexibility. Studies showed good model fit and internal consistencies.
PCS (The pain catastrophizing scale)
Time frame: Through study completion, an average of 9 month
The PCS is a self-administered questionnaire that consists of 13 items to assess the extent of the patient's catastrophizing thoughts and behaviors. It comprises three subscales: helplessness, magnification, and rumination. The questionnaire is completed in relation to the patient's thoughts and feelings when they are in pain. The scores for the subscales are given by the sum of the corresponding items, and the total score is computed by summation of all items. The PCS score ranges from 0 to 52 points.
EQ (Experiences Questionnaire)
Time frame: Through study completion, an average of 9 month
EQ is a 20-item self-report scale measuring decentering, in which participants rate items on a 7-point Likert-type scale (1 = never to 7 = all the time). It evaluates an individual's ability to decenter, namely, the ability to regard thoughts and feelings as temporary and transient. The EQ focuses on three facets of decentering: the ability to view one's self as separate from one's thoughts, the ability to non-judgmentally observe one's negative experiences without habitually reacting, and the capacity for self-compassion. Multiple studies have demonstrated sound psychometric properties of the EQ.
BAI (The Beck Anxiety Inventory)
Time frame: Through study completion, an average of 9 month
BAI is a 21-item questionnaire that measures cognitive and somatic symptoms of anxiety, with higher scores indicating increased anxiety, (range 0-63). Sample items include "unable to relax" and "heart pounding or racing." Good psychometric properties have been demonstrated among college, medical, and psychiatric samples. The BAI is a 21-item scale that measures cognitive, somatic, and affective symptoms of anxiety.
BAQ (Body awareness questionnaire)
Time frame: Through study completion, an average of 9 month
The 18-item Body Awareness Questionnaire assessed reported attentiveness to normal non-emotive body processes, sensitivity to body cycles/rhythms, ability to detect small changes in normal functioning, and to anticipate bodily reactions ("I am aware of a cycle in my activity level throughout the day", and "I notice specific bodily reactions to being over hungry"). It is a 7-point Likert-type scale (1 = Not at all true of me to 7 = Very true of me). Studies reported good reliability and validity of the BAQ. The total score ranges from 18 to 126 points. Higher scores indicate greater body awareness.
The WHOQOL-BREF (The World Health Organization Quality of Life)
Time frame: Through study completion, an average of 9 month
WHOQOL is an abbreviated 26-item version of the WHOQOL-100, on a scale of 1-5. It contains one general QOL item, one general health item, and 24 specific items-one item from each of the 24 QOL facets of the WHOQOL-100. The 24 specific items cover four broad domains: physical, psychological, social, and environmental quality of life. The items are answered on five-point scales, which assess the intensity, capacity, frequency, and evaluation of QOL facets with respect to the last two weeks. Negatively keyed items are reversely scored, so that higher values indicate better QOL.
VAS Pain (Visual Analog Scale for Pain)
Time frame: Through study completion, an average of 9 month
The VAS pain is a self- report measure continuous scale, comprised of a horizontal line ranged of 0-100. VAS was based on 3 single- item continuous scale, for pain intensity, shame in one's disease and the third measured the levels of how much the disease has taken over the patients identity. The VAS is the most commonly used measure for assessing levels of pain by physicians in medical setting.
DAI-10 (Drug Attitude Inventory)
Time frame: Through study completion, an average of 9 month
The DAI includes a series of 10 questions, each with true/false answers, regarding the adherent of patients to their prescribed medication, and pertaining to various aspects of the patient's perceptions and experiences of treatment. The original scale consists of 30 questions, but a short form consisting of 10 questions has also been validated.
Home Practice Diary
Time frame: Through study completion, an average of 9 month
In order to comprehensively assess mindfulness practice at home, participants would fill out a daily home practice diary, which will include the date, time, type, and duration of both formal and informal mindfulness home practice, along with any comments on their experience. This home practice form is commonly used in MBSR interventions.
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 11 Mar 2020.
- Background: PubMed 7877156Adams SG Jr, Dammers PM, Saia TL, Brantley PJ, Gaydos GR. Stress, depression, and anxiety predict average symptom severity and daily symptom fluctuation in systemic lupus erythematosus. J Behav Med. 1994 Oct;17(5):459-77. doi: 10.1007/BF01857920.
- Background: PubMed 19369473Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.
- Background: PubMed 19664287Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
- Background: PubMed 22751025Carson JW, Carson KM, Jones KD, Mist SD, Bennett RM. Follow-up of yoga of awareness for fibromyalgia: results at 3 months and replication in the wait-list group. Clin J Pain. 2012 Nov-Dec;28(9):804-13. doi: 10.1097/AJP.0b013e31824549b5.
- Background: PubMed 24737367Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
- BackgroundEmmelkamp, P. M., Bouman, T. K., & Blaauw, E. (1994). Individualized versus standardized therapy: A comparative evaluation with obsessive-compulsive patients. Clinical Psychology & Psychotherapy, 1(2), 95-100.
- Background: PubMed 16194262Emori A, Matsushima E, Aihara O, Ohta K, Koike R, Miyasaka N, Kato M. Cognitive dysfunction in systemic lupus erythematosus. Psychiatry Clin Neurosci. 2005 Oct;59(5):584-9. doi: 10.1111/j.1440-1819.2005.01418.x.
- Background: PubMed 22426704Ferrari R. A cohort-controlled trial of the addition of customized foot orthotics to standard care in fibromyalgia. Clin Rheumatol. 2012 Jul;31(7):1041-5. doi: 10.1007/s10067-012-1966-8. Epub 2012 Mar 20.
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- Individual participant dataSharing planned: Yes. IPD would be available to other researchers, including Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report and Analytic Code through e- mail or publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness- Based Intervention in people with Psychological, run by Bar-Ilan University, Israel at 2 sites in Israel.
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 5 inclusion and 3 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
FIQR (Fibromyalgia impact questionnaire revised) (time frame: Through study completion, an average of 9 month). The study lists 13 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 NCT04304664, which also lists 24 linked publications.
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 11 Mar 2020.