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

January 11, 2010
May 2, 2012
October 2009
May 2011   (final data collection date for primary outcome measure)
chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046370 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Fatigue Syndrome
  • Chronic Fatigue
  • Fibromyalgia
Behavioral: Amygdala Retraining Program
Mind-body intervention.
  • Experimental: ARP intervention
    Intervention: Behavioral: Amygdala Retraining Program
  • No Intervention: No intervention
Toussaint LL, Whipple MO, Abboud LL, Vincent A, Wahner-Roedler DL. A mind-body technique for symptoms related to fibromyalgia and chronic fatigue. Explore (NY). 2012 Mar-Apr;8(2):92-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01046370
09-003509
No
Ann Vincent, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Ann Vincent, MD Mayo Clinic
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP