Tuesday, January 19, 2010

Mayo Clinic CFS research is recruiting

Source: NIH
Date:   January 11, 2010
URL:    http://clinicaltrials.gov/ct2/show/NCT01046370


A pilot study of Amygdala retraining program in patients with
Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
-------------------------------------------------------------

    This study is currently recruiting participants.
    Verified by Mayo Clinic, January 2010
    First Received: January 11, 2010 No Changes Posted
    Sponsor:                       Mayo Clinic
    Information provided by:       Mayo Clinic
    ClinicalTrials.gov Identifier: NCT01046370


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   Behavioral: Amygdala Retraining Program
Chronic Fatigue
Fibromyalgia
------------------------------------------------------------------

Study Type:     Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment,
                Efficacy Study
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:

MedlinePlus related topics: Chronic Fatigue Syndrome Fibromyalgia
U.S. FDA Resources
   http://www.nlm.nih.gov/medlineplus/
   http://www.nlm.nih.gov/medlineplus/chronicfatiguesyndrome.html
   http://www.nlm.nih.gov/medlineplus/fibromyalgia.html
   http://clinicaltrials.gov/ct2/info/fdalinks


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]


Estimated Enrollment:              30
Study Start Date:                  October 2009
Estimated Study Completion Date:   July 2010
Estimated Primary Completion Date: June 2010 (Final data collection
                                   date for primary outcome measure)

----------------------------------------------------------------------
Arms              Assigned Interventions
----------------------------------------------------------------------
ARP               Behavioral: Amygdala Retraining Program
intervention:     The Amygdala Retraining Program (ARP) attempts to
Experimental      retrain the sensitized neuronal network present in
                  patients with Chronic Fatigue Syndrome, Chronic
                  Fatigue and Fibromyalgia through mind-body practices
                  such as cognitive restructuring via neurolinguistic
                  programming, yoga based breathing and simple
                  mindfulness based meditation.
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
* access to a DVD player

Exclusion Criteria:

* 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


Contacts

Contact: Ann Vincent, MBBS, MD 507-284-3244 vincent.ann@mayo.edu


Locations

United States, Minnesota

Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Ann Vincent, MBBS, MD
Principal Investigator: Lana L Abboud
Sub-Investigator: Connie A Luedtke, RN
Sub-Investigator: Janet A Guderian, RN
Sub-Investigator: Loren L Toussaint, PhD


Sponsors and Collaborators

Mayo Clinic


Investigators

Principal Investigator: Ann Vincent, MBBS, MD Mayo Clinic


More Information

No publications provided


Responsible Party:    Mayo Clinic (Ann Vincent, MBBS, MD)
Study ID Numbers:     09-003509
Study First Received: January 11, 2010
Last Updated:         January 11, 2010
ClinicalTrials.gov Identifier: NCT01046370
                      http://clinicaltrials.gov/ct2/show/NCT01046370
                      History of Changes
                      http://clinicaltrials.gov/ct2/archive/NCT01046370
Health Authority:    United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on January 14, 2010

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(c) 2010 National Institutes of Health

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