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Protocol: Understanding and restoring dopaminergic function in [FM] patients using a mindfulness-based psychological intervention, 2021, Ledermann

Discussion in 'Other psychosomatic news and research' started by Andy, Jan 27, 2022.

  1. Andy

    Andy Committee Member

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    Full title: Understanding and restoring dopaminergic function in fibromyalgia patients using a mindfulness-based psychological intervention: a [18F]-DOPA PET study. Study protocol for the FIBRODOPA study—a randomized controlled trial

    Abstract

    Background
    Fibromyalgia (FM) is a very prevalent and debilitating chronic pain disorder that is difficult to treat. Mindfulness-based techniques are regarded as a very promising approach for the treatment of chronic pain and in particular FM. The Mindfulness-Oriented Recovery Enhancement (MORE) intervention, a mindfulness-based group intervention, has shown beneficial effects in opioid-treated chronic pain patients, including reduced pain severity, functional interference, and opioid dosing, by restoring neurophysiological and behavioral responses to reward. The first evidence for a hypodopaminergic state and impaired reward processing in FM has been reported. However, little is known about its impact on dopamine (DA) function and in particular with regard to DA responses to monetary reward in FM. The aim of the present study protocol is to evaluate if MORE is able to restore the DA function in FM patients, in particular with regard to the DA responses to reward, and to reduce pain and mood complaints in FM.

    Methods
    The present study is a multi-center interventional RCT with 3 time points: before the intervention, after completion of the intervention, and 3 months after completion of the intervention. Sixty-four FM patients will be randomly assigned to either the MORE intervention (N = 32) or a non-intervention control group (N = 32). Additionally, a comparison group of healthy women (N = 20) for PET measures will be enrolled and another group of healthy women (N = 15) will do the ambulatory assessments only. The MORE intervention consists of eight 2-h-long group sessions administered weekly over a period of 8 weeks. Before and after the intervention, FM participants will undergo [18F] DOPA positron emission tomography (PET) and functional MR imaging while performing a reward task. The primary outcome will be endogeneous DA changes measured with [18F] DOPA PET at baseline, after the intervention (after 8 weeks for the non-intervention control group), and at 3 months’ follow-up. Secondary outcomes will be (1) clinical pain measures and FM symptoms using standardized clinical scales; (2) functional brain changes; (3) measures of negative and positive affect, stress, and reward experience in daily life using the ambulatory assessment method (AA); and (4) biological measures of stress including cortisol and alpha-amylase.

    Discussion
    If the findings of this study confirm the effectiveness of MORE in restoring DA function, reducing pain, and improving mood symptoms, MORE can be judged to be a promising means to improve the quality of life in FM patients. The findings of this trial may inform health care providers about the potential use of the MORE intervention as a possible non-pharmacological intervention for FM.

    Open access, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05798-1
     
  2. Arnie Pye

    Arnie Pye Senior Member (Voting Rights)

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    They are paying people to take part in some luck-based totally pointless "game". In what way can this be adapted to real life? It sounds like total nonsense to me.
     
    Peter Trewhitt and alktipping like this.
  3. rvallee

    rvallee Senior Member (Voting Rights)

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    When something has been "promising" for decades, that's another word that has lost all meaning. Especially when it's both "promising" and "has been forced for years onto those patients". There are genuinely areas of medicine that make the average politician look honest and sincere given how Orwellian they are with the truth. The amount of speculative hype in the discussion is at Silicon Valley startup level. This has no place whatsoever in health care.
     
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  4. Hutan

    Hutan Moderator Staff Member

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    Interesting to read this justification for using a wait-list control in the trial design, in response to a peer reviewer asking for such a justification:
    They seem to be suggesting that a placebo intervention that doesn't have an effect might elicit 'so-called resentful demoralisation'. Surely a wait-list control group is much more likely to elicit a negative interpretation of symptoms than an active control intervention?

    The authors seem exceedingly sure that their intervention will not be 'non-efficacious'. They certainly don't seem to be in any state of equipoise about it when they write that, because of the FM symptomology, with respect to a potential placebo intervention, it would be a 'waste of time and energy' for the participants to 'come to our centers for an intervention without any specific effects'. I think these researchers have to decide whether they are running a proper trial. If they are, then they can't just wave away the need for a proper control arm because the participants will be inconvenienced, particularly given the number of subjective outcomes.

    The suggestion that it would be too hard to provide a placebo treatment 'because the interaction between the participants and the reaction of the therapist to them cannot be fully controlled' seems pretty vacuous. Surely that variability would apply just as much to the MORE treatment?

    The proposed trial design will not distinguish the impact of group meetings on reported pain and well-being from the impact of the specific MORE mindfulness/positive thinking/whatever intervention (no doubt trademarked, and able to be franchised...). The reasoning for a wait-list control seems to lack logic.

    (some edits to clarify my meaning)
     
    Last edited: Jan 28, 2022
  5. Hutan

    Hutan Moderator Staff Member

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    There doesn't seem to be a lot of evidence for the idea that there is a lack of dopamine binding in the brains of fibromyalgia sufferers yet. These authors appear to be trying to build on a 2006 study with just 6 women with FM, and the abstract doesn't say which brain regions were found to be have a low capacity for DOPA binding.
    Reduced Presynaptic Dopamine Activity in Fibromyalgia Syndrome Demonstrated With Positron Emission Tomography: A Pilot Study, 2006

    There's this more recent study with a larger group, but it isn't clear from the abstract whether differences in dopamine binding identified in specific brain regions are likely to be just the result of chance - and whether the levels in FM are higher or lower than in healthy controls.
    Relation of dopamine receptor 2 binding to pain perception in female fibromyalgia patients with and without depression--A [¹¹C] raclopride PET-study, 2016

    Of course, even if there are lower dopamine binding capacities in some specific parts of the FM brain, it's another leap again to assume that 8 weeks of mindfulness, positivity and 'savouring' are going to change those levels. I'm interested to see the results of this study. It's just a shame it is being done by researchers who so clearly want their hypotheses to be true.

    (edit to try to make clear that it is dopamine binding capacity that I think is being measured, rather than dopamine levels per se. )
     
    Last edited: Jan 28, 2022
  6. strategist

    strategist Senior Member (Voting Rights)

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    Intervention description {11a}
    FM participants will participate in the MORE intervention or in a non-intervention control group. The non-intervention control group does not include any intervention. The MORE treatment is manual-based [28], consists of 8 sessions, and offers instruction in applying mindfulness and related skills to the following topics: discriminating between nociception, pain, and suffering; gaining awareness of automaticity and coping habits in chronic pain; disrupting the link between negative emotions, catastrophizing, and pain experience through reappraisal; refocusing attention from pain and life stressors to savor pleasant experiences; promoting acceptance instead of suppression of experience; and developing a mindful recovery plan. Mindfulness training will involve mindful breathing and body scan techniques, with an emphasis on developing metacognitive awareness and shifting attention from affective to sensory processing of pain and craving sensations. Sessions will be audio recorded for control of therapists’ adherence with the manual. MORE participants will be asked to engage in daily 15-min mindfulness practice sessions at home guided by a MP3 recording of the meditations. MORE is a manualized intervention that is centered on three therapeutic processes: mindfulness, reappraisal, and savoring. The MORE manual and the meditations are translated in French and in German. The non-intervention control group includes continuation of treatment as usual.


    Looks like just another group of healthy people wanting to impose their misconceptions on the chronically ill, and probably confusing "changing how patients talk about their pain to others" with "having successfully treated pain". As well as reversing cause and effect, and confusing the end with the means.

    My interest in this study plummeted after reading this.
     
    Last edited: Jan 28, 2022
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  7. strategist

    strategist Senior Member (Voting Rights)

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    I get the importance of maintaining quality of life in chronic illness that negatively affects quality of life. How to best achieve that?

    It would be interesting to hear not just the views of researchers but that of the patients, who are the real experts.
     
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  8. shak8

    shak8 Senior Member (Voting Rights)

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    The lead researcher is from the University of Zurich, department of psychiatry and psychosomatic medicine.

    Need I say more?

    I read parts of the study and was incensed by the theory that we with fibro are not motivated (the dopamine deficit theory). I have been suffering a three-day (so far) constant 'muscle spasm' (for lack of a better term, a fibro-induced wide swath of constant intolerable pain). I got myself into trouble precisely by being motivated to improve my muscle fitness, which is akin to being in denial about the seriousness of the consequences of going beyond my capacities.

    So I wrote a pointed email to the lead researcher about how trivial any effect of mindfulness or any other psych modality for the severe pain of fibromyalgia. We need more effective drugs, biopharma research. I asked: have you or anyone on your team ever exerienced severe chronic pain? You would make more impact by a qualitative study of a few patients and how they cope, how denial of illness messes with them, etc.

    My email bounced back--she's out for maternity leave until May.
     
    Last edited: Jan 28, 2022
  9. Trish

    Trish Moderator Staff Member

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    How frustrating and unprofessional of them not to have someone else to receive communcation about the project. Maybe send it to their head of department, if you can find an email address. These researchers need to be made aware of how useless they are.
     
  10. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    Yeah, well, a test treatment that doesn't have an effect might piss people off so best not to test it at all?

    "The easiest person to fool is yourself' guys.
     
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  11. shak8

    shak8 Senior Member (Voting Rights)

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    A review below about the descending pathway of pain modulation by dopamine.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057207/

    From the review just above, these quotes:

    "However, a recent study reported that although dopamine appears to affect expectations and desires, dopamine changes in the brain do not affect emotional pain in patients with chronic neuropathic pain after placebo intervention."

    "Dopamine in the NAc (nucleus acumbens) is critical for reward and motivation, including the reward from pain relief, thus targeting reward/motivation circuits could be used for pain modulation."
     
    Last edited: Jan 29, 2022
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  12. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    They might get a better result if the investigators had the scans before and after gathering self-fulfilling results.
     
    Last edited by a moderator: Jan 28, 2022
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