CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 389 enrolled
Drug / intervention
Fibromyalgia Integrative Training for Teens +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03268421
NCT03268421N/ACompleted
CompareCT.gov

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

Children's Hospital Medical Center, Cincinnati·interventional·Posted Aug 31, 2017·Updated Feb 14, 2025

In Brief

A clinical study evaluating Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy, and 1 other intervention for Fibromyalgia and 4 related conditions. Completed, enrolled 389 participants across 7 sites in 2 countries.

Detailed Summary

This study evaluated 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 received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases
CountriesCanada, United States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartJan 2, 2018
Primary CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.8 years ago

Interventions

Fibromyalgia Integrative Training for Teensbehavioral

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.

Cognitive Behavioral Therapybehavioral

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.

Graded Aerobic Exercisebehavioral

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.