FibromyalgiaNCT02190474
Mindfulness Interventions and Chronic Widespread Pain in Adolescents
A study testing Mindfulness Group in people with Fibromyalgia and Chronic Widespread Pain, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Fibromyalgia, Chronic Widespread Pain
- What is being tested?
- Mindfulness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Interventions and Chronic Symptoms
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.
Read the 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.
- Conditions
- Fibromyalgia, Chronic Widespread Pain
- Being tested
- Mindfulness Group
- Keywords
- fibromyalgia, juvenile fibromyalgia, juvenile primary fibromyalgia syndrome (JPFS), adolescent pain, mindfulness, MBSR
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
Program Adherence
Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Ather Ali, ND, MPH, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190474
- Sponsor's protocol ID
- 1201009502
- Other IDs
- K23AT006703
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28088398
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Interventions and Chronic Symptoms
- ClinicalTrials.gov ID
- NCT02190474
- Acronym / sponsor ID
- 1201009502
- Conditions
- Fibromyalgia, Chronic Widespread Pain
- Keywords
- fibromyalgia, juvenile fibromyalgia, juvenile primary fibromyalgia syndrome (JPFS), adolescent pain, mindfulness, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Behavioral: Mindfulness GroupThese 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness GroupParticipants 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. | Behavioural | Mindfulness Group |
Primary outcome
Feasibility and retention
Time frame: 8 weeks
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.
7 secondary outcomes
Program Adherence
Time frame: 8 weeks
Program Use
Time frame: 8 weeks
Program Practicality
Time frame: 8 weeks
Functional Disability Inventory (FDI)
Time frame: 8 weeks
Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)
Time frame: 8 weeks
Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 28088398Ali 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ather Ali, ND, MPH, MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Group in people with Fibromyalgia and Chronic Widespread Pain, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and retention (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.