Status:
COMPLETED
Mindfulness Interventions and Chronic Widespread Pain in Adolescents
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Fibromyalgia
Chronic Widespread Pain
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain and other similar c...
Detailed Description
The primary objective is to test the feasibility, safety, tolerability and acceptability of a mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic widespread pain. T...
Eligibility Criteria
Inclusion
- 2010 American College of Rheumatology (ACR) criteria based on the Widespread Pain Index (WPI) and Symptom Severity (SS) checklist.
- Functional Disability Score ≥13 indicating at least moderate disability
- Average pain intensity in the past week ≥ 4 on a 0-10 cm Visual Analog Scale.
- Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions.
- Chronic symptoms such as fatigue, pain, bowel dysfunction, perceived cognitive impairment, or other non-specific symptoms persisting for 3-months or more, severe enough to have led to more than one visit to a medical provider. These symptoms must have not been found to be due to a definable general medical disorder despite adequate evaluation.
Exclusion
- Diagnosis of an autoimmune or rheumatologic disease
- Current regular mindfulness meditation activity
- Serious illness (including mental illness/psychopathology) within 90 days prior to screening
- Inability or unwillingness of a parent to give consent/permission or child to assent
- Current use of opioid analgesics
- Current prescription for antidepressant medications
- Screening positive on the Columbia Suicide Screen (CSS)
- Active participation (weekly or more often) in a fibromyalgia or chronic disease support group
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02190474
Start Date
July 1 2014
End Date
December 1 2016
Last Update
March 3 2017
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06519