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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann Vincent, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01046370
First received: January 11, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention
Chronic Fatigue Syndrome
Chronic Fatigue
Fibromyalgia
Behavioral: Amygdala Retraining Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • quality of life as assessed by the Short Form-36 (SF-36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARP intervention Behavioral: Amygdala Retraining Program
Mind-body intervention.
No Intervention: No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046370

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

Publications:
Responsible Party: Ann Vincent, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01046370     History of Changes
Other Study ID Numbers: 09-003509
Study First Received: January 11, 2010
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014