Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
NCT03268421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389
Last updated 2025-02-14
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.
Conditions
- Fibromyalgia
- Myofascial Pain Syndrome
- Muscular Diseases
- Musculoskeletal Disease
- Rheumatic Diseases
Interventions
- 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.
- 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.
- 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.
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH -
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Susmita Kashikar-Zuck, PhD · Children's Hospital Medical Center, Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-02
- Primary Completion
- 2023-12-21
- Completion
- 2023-12-21
Countries
- United States
- Canada
Study Locations
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