| 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
Chronic Fatigue Fibromyalgia |
Behavioral: Amygdala Retraining Program
|
| 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) |
- chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 intervention: Experimental | Behavioral: Amygdala Retraining Program
The Amygdala Retraining Program (ARP) attempts to 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 |
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 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
| Contact: Ann Vincent, MBBS, MD | 507-284-3244 | vincent.ann@mayo.edu |
| 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 | |
| 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 History of Changes |
| 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 13, 2010
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