Fibromyalgia Clinical Trial
Official title:
A Pilot Study of Amygdala Retraining Program (ARP) Versus Control (C) in Patients With Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM)
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 ARP 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 ARP reported improvement in 92% of
patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta
2009). However ARP has never been formally studied in CFS.
We propose to gather preliminary data on the efficacy and feasibility of ARP versus C 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 ARP or C
group. The ARP group will receive an additional 2.5 hour training surrounding core concepts
of the ARP program. They will then be given the ARP 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 C group will receive only standard care.
However they will receive a complementary copy of the ARP 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 ARP and any
specific difficulties they encountered in the practice of the program.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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