A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
Primary Purpose
Chronic Fatigue Syndrome, Chronic Fatigue, Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amygdala Retraining Program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ARP intervention
No intervention
Arm Description
Outcomes
Primary Outcome Measures
chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity
Secondary Outcome Measures
fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS)
pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2)
quality of life as assessed by the Short Form-36 (SF-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01046370
Brief Title
A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Chronic Fatigue, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARP intervention
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Amygdala Retraining Program
Intervention Description
Mind-body intervention.
Primary Outcome Measure Information:
Title
chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS)
Time Frame
6 months
Title
pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2)
Time Frame
6 months
Title
quality of life as assessed by the Short Form-36 (SF-36)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Vincent, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22385563
Citation
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.
Results Reference
result
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A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
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