Clinical trial NCT04304664: Mindfulness- Based Intervention for Fibromyalgia Patients
Official title: The Efficacy of Mindfulness- Based Intervention for Fibromyalgia Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological
Keywords: Mindfulness
Fibromyalgia
Mindfulness- Based Intervention (MBI)
Stress- Related disease
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2020-03-11
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. confirmation of a clinical diagnosis of Lupus by the patient's own physician
2. age 18 years or older
3. Hebrew speakers
4. physical ability to attend group intervention sessions
5. psychological ability to practice mindfulness (no cognitive extreme impairments, no psychosis, no suicidal tendencies)

Exclusion Criteria:

1. serious mental health condition (such as suicidal state, alcohol and drug abuse, schizophrenia)
2. serious physical condition that would not enable participation
3. participation in another study.

Primary outcomes:
measure: FIQR (Fibromyalgia impact questionnaire revised)
timeFrame: Through study completion, an average of 9 month
measure: PSS (Perceived Stress Scale)
timeFrame: Through study completion, an average of 9 month
measure: PHQ-9 (The Patient Health Questionnaire-9 )
timeFrame: Through study completion, an average of 9 month
measure: FFMQ (Five Facet Mindfulness Questionnaire)
timeFrame: Through study completion, an average of 9 month
measure: PIPS (Psychological Inflexibility in Pain Scale)
timeFrame: Through study completion, an average of 9 month
measure: PCS (The pain catastrophizing scale)
timeFrame: Through study completion, an average of 9 month
measure: EQ (Experiences Questionnaire)
timeFrame: Through study completion, an average of 9 month
measure: BAI (The Beck Anxiety Inventory)
timeFrame: Through study completion, an average of 9 month
measure: BAQ (Body awareness questionnaire)
timeFrame: Through study completion, an average of 9 month
measure: The WHOQOL-BREF (The World Health Organization Quality of Life)
timeFrame: Through study completion, an average of 9 month
measure: VAS Pain (Visual Analog Scale for Pain)
timeFrame: Through study completion, an average of 9 month
measure: DAI-10 (Drug Attitude Inventory)
timeFrame: Through study completion, an average of 9 month
measure: Home Practice Diary
timeFrame: Through study completion, an average of 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Ramat Gan
country: Israel
facility: Bar- Ilan University
Study officials:
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