On Jan 11, the Mayo Clinic Rochester (Minnesota) listed “A Pilot Study of Amygdala Retraining Program in Patients with Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia” with ClinicalTrials.gov.
This six-month trial of Ashok Gupta’s Amygdala Retraining Program™ (www.prohealth.com//library/showArticle.cfm?libid=14508) will include a pilot cohort of 30 patients.
The trial description states:
“The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM).
“CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (Fukuda 1994).
“Current literature points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The Amygdala Retraining Program attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation.
“A case series of 33 patients with CFS and Amygdala Retraining Program reported improvement in 92% of patients with two-thirds of patients reaching 80% to 100% of pre-illness levels of health (Gupta 2009). However, Amygdala Retraining Program has never been formally studied in CFS.
“We propose to gather preliminary data on the efficacy and feasibility of Amygdala Retraining Program versus control on fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will undergo standard clinical treatment which consist of a 2 day self-management program in the Chronic Fatigue Clinic. Following this, participants will be randomized into the Amygdala Retraining Program or control group. The Amygdala Retraining Program group will receive an additional 2.5 hour training surrounding core concepts of the ARP program. They will then be given the Amygdala Retraining Program DVD program and booklet, to reinforce and continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support.
“The control group will receive only standard care. However they will receive a complementary copy of the Amygdala Retraining Program program at the end of the study (6 month time point) as a gift for participation in the study.
“Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36 (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your Medical Outcome Profile (MYMOP-2).
“Feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of Amygdala Retraining Program and any specific difficulties they encountered in the practice of the program.”
To read more about the trial and for contact information, go to the ClinicalTrials.gov listing (http://clinicaltrials.gov/ct2/show/NCT01046370)