FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic
Objective: To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neur...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001569 |
| _version_ | 1811201256433123328 |
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| author | Susmita Kashikar-Zuck Kimberly A. Barnett Sara E. Williams Megan Pfeiffer Staci Thomas Katie Beasley Leigh Ann Chamberlin Katiliya Mundo Richard F. Ittenbach James Peugh Robert C. Gibler Anne Lynch-Jordan Tracy V. Ting Brooke Gadd Janalee Taylor Alana Goldstein-Leever Mark Connelly Deirdre E. Logan Amy Williams Emily O. Wakefield Gregory D. Myer |
| author_facet | Susmita Kashikar-Zuck Kimberly A. Barnett Sara E. Williams Megan Pfeiffer Staci Thomas Katie Beasley Leigh Ann Chamberlin Katiliya Mundo Richard F. Ittenbach James Peugh Robert C. Gibler Anne Lynch-Jordan Tracy V. Ting Brooke Gadd Janalee Taylor Alana Goldstein-Leever Mark Connelly Deirdre E. Logan Amy Williams Emily O. Wakefield Gregory D. Myer |
| author_sort | Susmita Kashikar-Zuck |
| collection | DOAJ |
| description | Objective: To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) is superior to CBT alone or graded aerobic exercise alone. Design/methods: The trial was originally designed as an in-person, group-based treatment with assessments at baseline, mid- and post-treatment, and four follow-up time points. The original study design and methodology was maintained with specific modifications to screening, consenting, assessments, and group-based treatments to be delivered in remote (telehealth) format in response to COVID-19 restrictions. Results: Study enrollment was paused in March 2020 for five months to revise operations manuals, pilot remote treatment sessions for accuracy and fidelity, complete programming of REDCap assent/consent and assessment materials, train study staff for new procedures and obtain regulatory approvals. The trial was relaunched and has been successfully implemented in remote format since July 2020. Trial metrics thus far demonstrate a consistent rate of enrollment, strong attendance at remote treatment sessions, high retention rates and high treatment fidelity after protocol adaptations were implemented. Conclusions: Preliminary findings indicate that FIT Teens protocol adaptations from in-person to remote are feasible and allowed for sustained enrollment, retention, and treatment fidelity comparable to the in-person format. Methodologic and statistical considerations resulting from the adaptations are discussed as well as implications for interpretation of results upon completion of the trial. |
| first_indexed | 2024-04-12T02:18:12Z |
| format | Article |
| id | doaj.art-84a0bf4d839646cebc53567f2e54ca07 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-12T02:18:12Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-84a0bf4d839646cebc53567f2e54ca072022-12-22T03:52:12ZengElsevierContemporary Clinical Trials Communications2451-86542022-12-0130101039FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemicSusmita Kashikar-Zuck0Kimberly A. Barnett1Sara E. Williams2Megan Pfeiffer3Staci Thomas4Katie Beasley5Leigh Ann Chamberlin6Katiliya Mundo7Richard F. Ittenbach8James Peugh9Robert C. Gibler10Anne Lynch-Jordan11Tracy V. Ting12Brooke Gadd13Janalee Taylor14Alana Goldstein-Leever15Mark Connelly16Deirdre E. Logan17Amy Williams18Emily O. Wakefield19Gregory D. Myer20Department of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Corresponding author. Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, MLC, 7039, Cincinnati, OH, 45229, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Sports Medicine, SPORT Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADepartment Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADivision of Pediatric Psychology and Neuropsychology, Nationwide Children's Hospital, Columbus, OH, USA; Department of Pediatrics, The Ohio State University, Columbus, OH, USADivision of Developmental and Behavioral Health, Children's Mercy Kansas City, Kansas City, MO, USADivision of Pain Medicine, Department of Anesthesia, Boston Children's Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USARiley Children's Hospital, Indianapolis, IN, USADepartment of Pediatrics, University of Connecticut School of Medicine, Farmington, CT, USA; Division of Pain and Palliative Medicine, Connecticut Children's Medical Center, Hartford, CT, USASports Performance and Research Center, Emory University School of Medicine, Atlanta, GA, USAObjective: To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) is superior to CBT alone or graded aerobic exercise alone. Design/methods: The trial was originally designed as an in-person, group-based treatment with assessments at baseline, mid- and post-treatment, and four follow-up time points. The original study design and methodology was maintained with specific modifications to screening, consenting, assessments, and group-based treatments to be delivered in remote (telehealth) format in response to COVID-19 restrictions. Results: Study enrollment was paused in March 2020 for five months to revise operations manuals, pilot remote treatment sessions for accuracy and fidelity, complete programming of REDCap assent/consent and assessment materials, train study staff for new procedures and obtain regulatory approvals. The trial was relaunched and has been successfully implemented in remote format since July 2020. Trial metrics thus far demonstrate a consistent rate of enrollment, strong attendance at remote treatment sessions, high retention rates and high treatment fidelity after protocol adaptations were implemented. Conclusions: Preliminary findings indicate that FIT Teens protocol adaptations from in-person to remote are feasible and allowed for sustained enrollment, retention, and treatment fidelity comparable to the in-person format. Methodologic and statistical considerations resulting from the adaptations are discussed as well as implications for interpretation of results upon completion of the trial.http://www.sciencedirect.com/science/article/pii/S2451865422001569Cognitive behavioral therapyJuvenile fibromyalgiaNeuromuscular trainingExercise interventionRandomized controlled trial |
| spellingShingle | Susmita Kashikar-Zuck Kimberly A. Barnett Sara E. Williams Megan Pfeiffer Staci Thomas Katie Beasley Leigh Ann Chamberlin Katiliya Mundo Richard F. Ittenbach James Peugh Robert C. Gibler Anne Lynch-Jordan Tracy V. Ting Brooke Gadd Janalee Taylor Alana Goldstein-Leever Mark Connelly Deirdre E. Logan Amy Williams Emily O. Wakefield Gregory D. Myer FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic Contemporary Clinical Trials Communications Cognitive behavioral therapy Juvenile fibromyalgia Neuromuscular training Exercise intervention Randomized controlled trial |
| title | FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic |
| title_full | FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic |
| title_fullStr | FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic |
| title_full_unstemmed | FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic |
| title_short | FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic |
| title_sort | fit teens rct for juvenile fibromyalgia protocol adaptations in response to the covid 19 pandemic |
| topic | Cognitive behavioral therapy Juvenile fibromyalgia Neuromuscular training Exercise intervention Randomized controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001569 |
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