FIT Teens: Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT03268421

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

420

Enrollment

Locations

Arms

70.9

Anticipated Duration (Months)

52.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants will receive the FIT Teens training; one third will receive CBT training; and one third of participants will receive the GAE training.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Disease Rheumatic Diseases	Behavioral: Fibromyalgia Integrative Training for Teens Behavioral: Cognitive Behavioral Therapy Behavioral: Graded Aerobic Exercise	N/A

Detailed Description

Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluates whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-pharmacologic trial comparing behavioral and exercise-based treatmentsNon-pharmacologic trial comparing behavioral and exercise-based treatments

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fibromyalgia Integrative Training for Teens Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.	Behavioral: Fibromyalgia Integrative Training for Teens This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. Other Names: FIT Teens
Active Comparator: Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.	Behavioral: Cognitive Behavioral Therapy This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. Other Names: CBT coping skills
Active Comparator: Graded Aerobic Exercise Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.	Behavioral: Graded Aerobic Exercise This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. Other Names: GAE

Arm

Intervention/Treatment

Experimental: Fibromyalgia Integrative Training for Teens

Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.

Behavioral: Fibromyalgia Integrative Training for Teens

This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.

Other Names:

FIT Teens

Active Comparator: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.

Behavioral: Cognitive Behavioral Therapy

Other Names:

CBT

coping skills

Active Comparator: Graded Aerobic Exercise

Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.

Behavioral: Graded Aerobic Exercise

Other Names:

GAE

Outcome Measures

Primary Outcome Measures

Change in functional disability [Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up]
The Functional Disability Inventory (FDI), a 15 item self-report measure will be used to assess participant's perceived difficulty in the performance of daily activities at home, school, recreational, and social domains due to pain. For this primary outcome, data from this questionnaires will be used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison will be the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).

Secondary Outcome Measures

Change in pain intensity [Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up]
A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
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
Stable medications prior to enrollment

Exclusion Criteria:

Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
Any medical condition determined by their physician to be a contraindication for physical exercise
Taking opioid pain medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
2	Riley Children's Hospital-University of Indiana	Indianapolis	Indiana	United States	46202
3	University of Louisville	Louisville	Kentucky	United States	40202
4	Boston Chilldren's Hospital	Boston	Massachusetts	United States	02116
5	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
6	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
7	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
8	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8