PMID- 35078536 OWN - NLM STAT- MEDLINE DCOM- 20220127 LR - 20220129 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 Dec 1 TI - 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. PG - 864 LID - 10.1186/s13063-021-05798-1 [doi] LID - 864 AB - 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04451564 . Registered on 3 July 2020. The trial was prospectively registered. CI - (c) 2021. The Author(s). FAU - Ledermann, K AU - Ledermann K AUID- ORCID: 0000-0001-9355-2979 AD - Department for Consultation-Liaison Psychiatry and Psychosomatic Medicine, University of Zurich, Zurich, Switzerland. katharina.ledermann@unifr.ch. AD - Department of Psychology, Chair of Clinical and Health Psychology, I-Reach Lab, University of Fribourg, Rue de Faucigny 2, 1700, Fribourg, Switzerland. katharina.ledermann@unifr.ch. FAU - von Kanel, R AU - von Kanel R AD - Department for Consultation-Liaison Psychiatry and Psychosomatic Medicine, University of Zurich, Zurich, Switzerland. FAU - Berna, C AU - Berna C AD - Center for Integrative and Complementary Medicine, Division of Anesthesiology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland. FAU - Sprott, H AU - Sprott H AD - University of Zurich, Arztpraxis Hottingen Zurich, Zurich, Switzerland. FAU - Burckhardt, M AU - Burckhardt M AD - Department of Psychology, Chair of Clinical and Health Psychology, I-Reach Lab, University of Fribourg, Rue de Faucigny 2, 1700, Fribourg, Switzerland. FAU - Jenewein, J AU - Jenewein J AD - Medizinische Universitat Graz, Universitatsklinik fur medizinische Psychologie und Psychotherapie, Graz, Austria. FAU - Garland, E L AU - Garland EL AD - College of Social Work, Center on Mindfulness and Integrative Health Intervention Development, University of Utah, Salt Lake City, USA. FAU - Martin-Solch, C AU - Martin-Solch C AD - Department of Psychology, Chair of Clinical and Health Psychology, I-Reach Lab, University of Fribourg, Rue de Faucigny 2, 1700, Fribourg, Switzerland. LA - eng SI - ClinicalTrials.gov/NCT04451564 GR - 325130-182766/1/Schweizerischer Nationalfonds zur Forderung der Wissenschaftlichen Forschung/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20211201 PL - England TA - Trials JT - Trials JID - 101263253 RN - 63-84-3 (Dihydroxyphenylalanine) RN - VTD58H1Z2X (Dopamine) SB - IM MH - Dihydroxyphenylalanine/adverse effects MH - Dopamine MH - Female MH - *Fibromyalgia/diagnostic imaging/therapy MH - Humans MH - *Mindfulness MH - Positron-Emission Tomography MH - Psychosocial Intervention MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Treatment Outcome PMC - PMC8790842 OTO - NOTNLM OT - Dopamine OT - F-18 DOPA PET OT - Fibromyalgia OT - Mindfulness-Oriented Recovery Enhancement OT - Reward OT - fMRI COIS- The authors declare that they have no competing interests. EDAT- 2022/01/27 06:00 MHDA- 2022/01/28 06:00 PMCR- 2021/12/01 CRDT- 2022/01/26 05:26 PHST- 2021/06/23 00:00 [received] PHST- 2021/11/04 00:00 [accepted] PHST- 2022/01/26 05:26 [entrez] PHST- 2022/01/27 06:00 [pubmed] PHST- 2022/01/28 06:00 [medline] PHST- 2021/12/01 00:00 [pmc-release] AID - 10.1186/s13063-021-05798-1 [pii] AID - 5798 [pii] AID - 10.1186/s13063-021-05798-1 [doi] PST - epublish SO - Trials. 2021 Dec 1;22(1):864. doi: 10.1186/s13063-021-05798-1.