Mindfulness Interventions and Chronic Widespread Pain in Adolescents
|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|
- 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.
- 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.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02190474
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|Contact: Theresa Weiss, MPH 203-737-1391 email@example.com|
|Contact: Ather Ali, ND MPH MHS (203) 737-2971 firstname.lastname@example.org|
|Principal Investigator: Ather Ali, ND MPH MHS|
|Principal Investigator:||Ather Ali, ND, MPH, MHS||Yale University|