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NCT01046370 · ClinicalTrials.gov registry record · NA
A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT01046370: Completed NA study, sponsored by Mayo Clinic.
NCT01046370 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01046370, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study 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:
Interventions
- BEHAVIORAL Amygdala Retraining Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01046370
The ClinicalTrials.gov registry entry for NCT01046370 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amygdala Retraining Program is the first listed.
NCT01046370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01046370 about?
NCT01046370 is a clinical study titled "A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia". 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 Fibromyalg...
What is the current status of trial NCT01046370?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2009-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01046370?
The interventions under investigation include: Amygdala Retraining Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01046370?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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