Mindfulness Interventions and Chronic Widespread Pain in Adolescents

Yale University

Status: Completed

Conditions: Fibromyalgia; Chronic Widespread Pain

Treatments: Behavioral: Mindfulness Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02190474

K23AT006703 (U.S. NIH Grant/Contract)

1201009502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Mindfulness Group

Experimental group

Description:

These adolescents will be invited to participate in a group mindfulness meditation program based on a protocol refined by the investigative team. The weekly group meetings will be taught by an MBSR teacher at the Yale School of Medicine, with experience teaching mindfulness interventions to adults, children, and adolescents.

Treatment:

Behavioral: Mindfulness Group