Clinical trial NCT02190474: Mindfulness Interventions and Chronic Widespread Pain in Adolescents
Official title: Mindfulness Interventions and Chronic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Widespread Pain
Keywords: fibromyalgia
juvenile fibromyalgia
juvenile primary fibromyalgia syndrome (JPFS)
adolescent pain
mindfulness
MBSR
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-07-15
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 chronic symptoms.

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.

The purpose of the program is to test how effective an 8-week meditation and stress reduction class is in helping adolescents with chronic symptoms (including but not limited to fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic fatigue, and others).

Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Yale School of Medicine.

Participants will attend 90-minute weekly group sessions and a 4-hour retreat with approximately 6-8 other study participants at Yale School of Medicine. Participants are asked to practice at home by listening to pre-recorded 15-20 minute guided meditations.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Feasibility and retention
timeFrame: 8 weeks
Secondary outcomes:
measure: Program Adherence
timeFrame: 8 weeks
measure: Program Use
timeFrame: 8 weeks
measure: Program Practicality
timeFrame: 8 weeks
measure: Functional Disability Inventory (FDI)
timeFrame: 8 weeks
measure: Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)
timeFrame: 8 weeks
measure: Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Ather Ali, ND, MPH, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ali A, Weiss TR, Dutton A, McKee D, Jones KD, Kashikar-Zuck S, Silverman WK, Shapiro ED. Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study. J Pediatr. 2017 Apr;183:184-190. doi: 10.1016/j.jpeds.2016.12.053. Epub 2017 Jan 12.