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Mindfulness Interventions and Chronic Widespread Pain in Adolescents

Primary Purpose

Fibromyalgia, Chronic Widespread Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Group
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, juvenile fibromyalgia, juvenile primary fibromyalgia syndrome (JPFS), adolescent pain, mindfulness, MBSR

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Group

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Program Adherence
Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries.
Program Use
Program use will be assessed by quantifying the amount of minutes that participants spent practicing MBSR. Participants will agree to receive and respond to a daily question of "How many minutes did you spend practicing MBSR yesterday" delivered by SMS/text message to their mobile telephone.
Program Practicality
Program practicality will be qualitatively assessed. Practicality (ability to attend intervention sessions and practice at home), interest in the intervention, perceived effectiveness, will be collected through brief (15-20 min) interviews following completion of the 8-week intervention.
Functional Disability Inventory (FDI)
The FDI assesses functional disability (physical and psychosocial functional impairment) in children and adolescents with chronic pain. Scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.
Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)
The FIQR-C (and analogue SIQR) is a pediatric version of the adult Revised Fibromyalgia Impact Questionnaire that has been the major physical function assessment in adult fibromyalgia trials. The FIQR has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change. The FIQR-C is used to measure subjects' physical function, overall impact of the syndrome, and symptom severity. It is scored from 0 (best) to 100 (worst) and takes less than 2 minutes to complete.
Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)
PedsQL 4.0 (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions.
Perceived Stress Scale (PSS)
The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has well-established validity in relation to physiological stress responses, anxiety, and depressive disorders.

Full Information

First Posted
July 11, 2014
Last Updated
March 2, 2017
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02190474
Brief Title
Mindfulness Interventions and Chronic Widespread Pain in Adolescents
Official Title
Mindfulness Interventions and Chronic Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Widespread Pain
Keywords
fibromyalgia, juvenile fibromyalgia, juvenile primary fibromyalgia syndrome (JPFS), adolescent pain, mindfulness, MBSR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and retention
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Program Adherence
Description
Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries.
Time Frame
8 weeks
Title
Program Use
Description
Program use will be assessed by quantifying the amount of minutes that participants spent practicing MBSR. Participants will agree to receive and respond to a daily question of "How many minutes did you spend practicing MBSR yesterday" delivered by SMS/text message to their mobile telephone.
Time Frame
8 weeks
Title
Program Practicality
Description
Program practicality will be qualitatively assessed. Practicality (ability to attend intervention sessions and practice at home), interest in the intervention, perceived effectiveness, will be collected through brief (15-20 min) interviews following completion of the 8-week intervention.
Time Frame
8 weeks
Title
Functional Disability Inventory (FDI)
Description
The FDI assesses functional disability (physical and psychosocial functional impairment) in children and adolescents with chronic pain. Scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.
Time Frame
8 weeks
Title
Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)
Description
The FIQR-C (and analogue SIQR) is a pediatric version of the adult Revised Fibromyalgia Impact Questionnaire that has been the major physical function assessment in adult fibromyalgia trials. The FIQR has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change. The FIQR-C is used to measure subjects' physical function, overall impact of the syndrome, and symptom severity. It is scored from 0 (best) to 100 (worst) and takes less than 2 minutes to complete.
Time Frame
8 weeks
Title
Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)
Description
PedsQL 4.0 (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions.
Time Frame
8 weeks
Title
Perceived Stress Scale (PSS)
Description
The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has well-established validity in relation to physiological stress responses, anxiety, and depressive disorders.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ather Ali, ND, MPH, MHS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28088398
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.
Results Reference
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Mindfulness Interventions and Chronic Widespread Pain in Adolescents

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