Understanding and restoring dopaminergic function in fibromyalgia patients using a Mindfulness-Oriented Recovery Enhancement (MORE) intervention: a multi-center, randomized 18F-DOPA PET-study (FIBRODOPA)
Aim of the study
Recent studies have shown that pain and reward are mediated by similar brain regions and that these regions are both associated with the dopamine and opiate systems.
Dopamine is a chemical messenger substance in the brain that is involved in many mental processes (e.g. attention control, emotional processes such as processing reward stimuli). Recent studies have shown that dopamine also plays an important role in pain regulation processes.
Fibromyalgia is a disease whose main symptom is chronic pain. It is a complex disease that is difficult to treat and occurs more frequently in women. There are still many unanswered questions regarding the psychophysiological basis of fibromyalgia. An earlier study by our team was able to show that in fibromyalgia, among other things, changes take place in the dopaminergic processes in the brain and that the brain's response to rewards is altered. The treatment of fibromyalgia is very difficult. International guidelines primarily recommend psychological interventions, especially cognitive behavioral therapy for patients with fibromyalgia.
Recently, there have been promising findings in the treatment of fibromyalgia associated with psychological therapies through newer streams of cognitive behavioral therapy called mindfulness-based cognitive therapy. Mindfulness is defined as the process of being constantly aware of the present moment. Among these new therapy programs is an 8-week mindfulness-based psychological training program called the MORE program, which combines mindfulness training with cognitive behavioral therapy and positive psychology. MORE is an abbreviation for Mindfulness-Oriented Recovery Enhancement and was originally developed for chronic pain patients with opioid addiction. Initial studies have shown that MORE reduces the perception of pain and promotes positive feelings. There is also initial evidence that MORE has an influence on the processing of reward stimuli in the brain, and that participants in the program learn to have positive feelings and enjoy everyday things in life again, which in turn has a positive effect on the perception of pain.
Fibromyalgia is very often associated with depression and negative feelings. The main symptoms of depression are a depressed mood and a loss of interest and pleasure over a longer period of time (several weeks). In this study, we want to investigate whether MORE can improve the functionality of the dopaminergic system in fibromyalgia, as well as the ability to experience positive events and things. We expect that this can lead to an improvement in general well-being and the perception of pain. In order to better understand the effect of this program, we would like to investigate the reward function in the brain of fibromyalgia sufferers before and after completing the program. Half of the fibromyalgia sufferers (random assignment) will go through the entire study process without the MORE program. However, these people have the opportunity to catch up on the program at a later date.
Prerequisite for participation
Group 1
All persons of the female sex who suffer from
diagnosed fibromyalgia can participate. In addition, they must be between 18 and 75 years old and have a dominant right hand. Good command of the German language desirable.
However, persons may
not participate:
- who smoke more than five cigarettes per week
- suffer from psychiatric, neurological disorders or current substance abuse or other acute or chronic somatic diseases (except fibromyalgia)
- are pregnant or breastfeeding
- if you have taken any medication in the last three months that affects the dopamine system, such as opioids, neuroleptics, antidepressants, lithium, antiepileptic drugs
- have taken part in nuclear medicine or physiological examinations with radiopharmaceuticals or radioactively labeled substances in the last 5 years
- participate in another clinical trial
Group 2
We are looking for
healthy female
volunteers for our fibromyalgia study. In addition, they must be between 18 and 75 years old and have a dominant right hand. Good command of the German language desirable.
However, persons may
not participate:
- who smoke more than five cigarettes per week
- suffer from psychiatric, neurological disorders or current substance abuse or other acute or chronic somatic diseases (except fibromyalgia)
- are pregnant or breastfeeding
- if you have taken any medication in the last three months that affects the dopamine system, such as opioids, neuroleptics, antidepressants, lithium, antiepileptic drugs
- have taken part in nuclear medicine or physiological examinations with radiopharmaceuticals or radioactively labeled substances in the last 5 years
- participate in another clinical trial
Compensation and time expenditure
Group 1
The compensation for full participation is € 400 plus a possible prize of up to € 108 from a task. The train journey to Zurich will be reimbursed. The examination consists of 3 visits, which take about 2 resp. Take 3 hours (screening and 2 test days)
Group 2
The compensation for full participation is 200.- plus a possible prize of up to 54.- from a task. The train journey to Zurich will be reimbursed. The examination consists of 2 appointments, which take about 1 or 2 hours. last 3 hours (screening and test day)
Procedure: What can you expect as a participant?
Group 1
First of all, we will carry out a diagnostic assessment to determine whether you are eligible to take part in the study. The diagnostic clarification includes interviews, questionnaires and a rheumatological examination (including tender point examination) and takes about 1.5 hours. This assessment takes place in Zurich (sometimes by telephone or video conference). You will then be randomly assigned to either the MORE group or the control group. If you are assigned to the control group, you can catch up on the MORE program at a later date after completing the two PET and fMRI measurements. The MORE program consists of 8 sessions at weekly intervals, each lasting two hours. The MORE program is carried out at the USZ and led by a trained clinical psychologist or psychotherapist. In order to obtain information on dopaminergic processes (they are presented under " 1. Objectives of the study ") in connection with the MORE program, positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) will be performed before and after completion of the MORE program. The PET measurement and the fMRI measurement each take 100-120 minutes. To find out about the brain's reward function, you will play a reward task and solve an emotion regulation task during your time in the scanner. In order to find out about your perception of pain in everyday life and your mood, you will enter questions about your mood, feelings, pain and positive experiences into an electronic diary on an Ipod Touch (measurements in everyday life), which we will provide you with for the duration of the study, before and after participating in the MORE program (or, if you have been assigned to the waiting list condition, at eight-week intervals) for one week each time you get up, in the morning, at noon, in the afternoon, in the evening and before going to sleep. These measurements are also repeated after 3 months. To obtain information on stress markers in saliva such as cortisol and alpha-amylase, you will collect a saliva sample five times a day for three days before and after the MORE program (in the same week as the other measurements). These samples are stored in your refrigerator at home and sent to the University of Fribourg in a pre-addressed envelope. To find out about the composition of your intestinal bacteria, you will give us a stool sample once. When placing the venous access for the PET measurement, we will take blood samples to examine genes related to pain perception. The saliva, stool and blood samples taken are given a code and thus analyzed in encrypted form.
Group 2
First of all, we will carry out a diagnostic assessment to determine whether you are eligible to take part in the study. The diagnostic assessment includes interviews and questionnaires and takes about 1 hour. This assessment takes place in Zurich (sometimes by telephone or video conference). This is followed by a
positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). The PET measurement and the fMRI measurement each take 100-120 minutes. To find out about the brain's reward function, you will play a reward task and solve an emotion regulation task during your time in the scanner. To find out about your perception of pain in everyday life and your mood, you will enter questions about your mood, feelings, pain and positive experiences in an electronic diary on an Ipod Touch (measurements in everyday life), which we will provide you with for the duration of the study, when you get up, in the morning, at midday, in the afternoon, in the evening and before you go to sleep. These measurements are also repeated after 3 months. To obtain information on stress markers in saliva such as cortisol and alpha-amylase, you will collect a saliva sample five times a day for three days (in the same week as the other measurements). These samples are stored in your refrigerator at home and sent to the University of Fribourg in a pre-addressed envelope. To find out about the composition of your intestinal bacteria, you will give us a stool sample once. When placing the venous access for the PET measurement, we will take blood samples to examine genes related to pain perception. The saliva, stool and blood samples taken are given a code and thus analyzed in encrypted form
Data protection
All data is treated confidentially. There is no medical benefit for the test subjects.
Please note that your data will be registered when a contact is established. If you are not interested in participating in the study, your data will be deleted immediately.