Trial record 53 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

Mindfulness Interventions and Chronic Widespread Pain in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02190474
First received: July 11, 2014
Last updated: May 14, 2015
Last verified: January 2015
  Purpose

The primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain.


Condition Intervention
Fibromyalgia
Chronic Widespread Pain
Behavioral: Mindfulness Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Determine the Feasibility and Acceptability of a Mindfulness Intervention for Adolescents With Juvenile Fibromyalgia/Chronic Widespread Pain

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Feasibility and retention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 who attend at least 80% of the weekly sessions.


Secondary Outcome Measures:
  • Program Adherence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries. Participants completing 75% of assigned home practice will be coded as adherent in a binary adherence variable.

  • Program Use [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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. The use of SMS/text messaging and/or email to track home practice will allow data completeness to be assessed multiple times per week.

  • Program Practicality [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 6-week intervention.

  • Functional Disability Inventory (FDI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Impact Questionnaire (FIQR-C) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The FIQR-C 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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    PedsQL 4.0 (76) (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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Group
These adolescents will be invited to participate in a group mindfulness meditation program based on methods originally developed for adult MBSR interventions (but not focused on chronic pain). 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
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.

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 resulting information will be used to refine the protocol for testing in a subsequent wait-list controlled randomized trial.

Our intervention will start with methods based on previously published adolescent mindfulness-based stress reduction (MBSR) protocols. We will incorporate an iterative process with the investigative team and mindfulness instructor, applying developmentally appropriate modifications that facilitate a practical and reproducible protocol that is consistent with MBSR core content.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190474

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Theresa Weiss, MPH    203-737-1391    theresa.weiss@yale.edu   
Contact: Ather Ali, ND MPH MHS    (203) 737-2971    ather.ali@yale.edu   
Principal Investigator: Ather Ali, ND MPH MHS         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Ather Ali, ND, MPH, MHS Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02190474     History of Changes
Other Study ID Numbers: 1201009502, K23AT006703
Study First Received: July 11, 2014
Last Updated: May 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
fibromyalgia
juvenile fibromyalgia
juvenile primary fibromyalgia syndrome (JPFS)
adolescent pain
mindfulness
MBSR

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 30, 2015