NCT02190474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

July 11, 2014

Last Update Submit

March 2, 2017

Conditions

FibromyalgiaChronic Widespread Pain

Keywords

fibromyalgiajuvenile fibromyalgiajuvenile primary fibromyalgia syndrome (JPFS)adolescent painmindfulnessMBSR

Outcome Measures

Primary Outcomes (1)

  • Feasibility and retention

    Feasibility and retention will be assessed after each cohort completes the group sessions. Feasibility of the intervention will be assessed by the proportion of eligible patients approached for the study who consent to participate and the proportion of the weekly sessions that are attended.

    8 weeks

Secondary Outcomes (7)

  • Program Adherence

    8 weeks

  • Program Use

    8 weeks

  • Program Practicality

    8 weeks

  • Functional Disability Inventory (FDI)

    8 weeks

  • Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)

    8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Mindfulness Group

EXPERIMENTAL

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.

Behavioral: Mindfulness Group

Interventions

Mindfulness GroupBEHAVIORAL

Participants will attend weekly 1-2-hour group sessions (of 6-8 persons) led by a trained expert based on the working MBSR protocol. The weekly sessions will be scheduled in a time mutually convenient for participants and their parent/guardian that will accompany them to each group session. The MBSR group sessions will take place at the Yale School of Medicine.

Mindfulness Group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • 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.

    PMID: 28088398RESULT

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ather Ali, ND, MPH, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

US(1)