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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046370
• Other study ID #: 09-003509
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: May 2, 2012
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue
• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

Intervention

Behavioral:
• Amygdala Retraining Program
Mind-body intervention.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1016/j.explore.2011.12.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity		6 months	No
Secondary	fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS)		6 months	No
Secondary	pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2)		6 months	No
Secondary	quality of life as assessed by the Short Form-36 (SF-36)		6 months	No