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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT006703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program Adherence | Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries. | 8 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ather Ali, ND, MPH, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28088398 | Result | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |