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A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01046370
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Ann Vincent, Mayo Clinic

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Chronic Fatigue Fibromyalgia Behavioral: Amygdala Retraining Program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ARP intervention Behavioral: Amygdala Retraining Program
Mind-body intervention.
No Intervention: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS) [ Time Frame: 6 months ]
  2. pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2) [ Time Frame: 6 months ]
  3. quality of life as assessed by the Short Form-36 (SF-36) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meet CDC criteria for Chronic Fatigue Syndrome, have been diagnosed with chronic fatigue, or meet the American College of Rheumatology criteria for fibromyalgia

Exclusion Criteria:

  • untreated hypo or hyper thyroidism
  • untreated hypo or hyper parathyroidism
  • untreated adrenal disorders
  • untreated diabetes
  • multiple sclerosis
  • acute or chronic hepatitis
  • history of cancer
  • untreated depression
  • chronic steroid use
  • acute inflammatory rheumatological conditions
  • untreated obstructive sleep apnea
  • narcolepsy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046370


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ann Vincent, MD Mayo Clinic
More Information
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Publications of Results:

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Responsible Party: Ann Vincent, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01046370    
Other Study ID Numbers: 09-003509
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Encephalomyelitis
Neuroinflammatory Diseases