ImportanceNeurofibromatoses (NF; NF1, NF2, and schwannomatosis) are hereditary tumor predisposition syndromes with a risk for poor quality of life (QOL) and no evidence-based treatments.ObjectiveTo compare a mind-body skills training program, the Relaxation Response Resiliency Program for NF (3RP-NF), with a health education program (Health Enhancement Program for NF; HEP-NF) for improvement of quality of life among adults with NF.Design, Setting, and ParticipantsThis single-blind, remote randomized clinical trial randomly assigned 228 English-speaking adults with NF from around the world on a 1:1 basis, stratified by NF type, between October 1, 2017, and January 31, 2021, with the last follow-up February 28, 2022.InterventionsEight 90-minute group virtual sessions of 3RP-NF or HEP-NF.Main Outcomes and MeasuresOutcomes were collected at baseline, after treatment, and at 6-month and 1-year follow-up. The primary outcomes were physical health and psychological domain scores of the World Health Organization Quality of Life Brief Version (WHOQOL-BREF). Secondary outcomes were the social relationships and environment domain scores of the WHOQOL-BREF. Scores are reported as transformed domain scores (range, 0-100, with higher scores indicating higher QOL). Analysis was performed on an intention-to-treat basis.ResultsOf 371 participants who underwent screening, 228 were randomized (mean [SD] age, 42.7 [14.5] years; 170 women [75%]), and 217 attended 6 or more of 8 sessions and provided posttest data. Participants in both programs improved from baseline to after treatment in primary outcomes of physical health QOL score (3RP-NF, 5.1; 95% CI, 3.2-7.0; P < .001; HEP-NF, 6.4; 95% CI, 4.6-8.3; P < .001) and psychological QOL score (3RP-NF, 8.5; 95% CI, 6.4-10.7; P < .001; HEP-NF, 9.2; 95% CI, 7.1-11.2; P < .001). Participants in the 3RP-NF group showed sustained improvements after treatment to 12 months; posttreatment improvements for the HEP-NF group diminished (between-group difference for physical health QOL score, 4.9; 95% CI, 2.1-7.7; P = .001; effect size [ES] = 0.3; and psychological QOL score, 3.7; 95% CI, 0.2-7.6; P = .06; ES = 0.2). Results were similar for secondary outcomes of social relationships and environmental QOL. There were significant between-group differences from baseline to 12 months in favor of the 3RP-NF for physical health QOL score (3.6; 95% CI, 0.5-6.6; P = .02; ES = 0.2), social relationships QOL score (6.9; 95% CI, 1.2-12.7; P = .02; ES = 0.3), and environmental QOL score (3.5; 95% CI, 0.4-6.5; P = .02; ES = 0.2).Conclusions and RelevanceIn this randomized clinical trial of 3RP-NF vs HEP-NF, benefits from 3RP-NF and HEP-NF were comparable after treatment, but at 12 months from baseline, 3RP-NF was superior to HEP-NF on all primary and secondary outcomes. Results support the implementation of 3RP-NF in routine care.Trial RegistrationClinicalTrials.gov Identifier: NCT03406208
Background Knee osteoarthritis (KOA) is the most common joint disorder in the United States and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available. Objective This mixed methods study aims to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video. Methods Participants were adults (aged ≥45 years) from rural Kentucky with obesity (BMI≥30 kg/m2), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (9-item Patient Health Questionnaire ≥10) recruited from 2 orthopedic centers. In phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N=9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N=5; 1 group). This research was guided by National Institutes of Health (NIH) model stage IA. Results Phase 1 qualitative analyses revealed nuanced information about challenges with coping and increasing activity, high interest in a mind-body activity program, program participation facilitators (flexibility with technology) and barriers (amotivation and forgetfulness), and perceived challenges with data collection procedures (blood and urine samples and homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers: acceptability (80%), expectancy (100%), credibility (100%), clinician adherence (90%), homework adherence (80%), questionnaire data collection (100%), program satisfaction (100%), and safety (100%). Adherence to ActiGraph wear (80% baseline, 20% posttest) and collection of blood samples (60%) were low. Participation in GetActive-OA was associated with signals of improvements in general coping (Cohen d=2.41), pain catastrophizing (Cohen d=1.24), depression (Cohen d=0.88), anxiety (Cohen d=0.78), self-efficacy (Cohen d=0.73), pain (Cohen d=0.39), and KOA symptoms (Cohen d=0.36). Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol. Conclusions Patients with KOA, depression, and obesity from rural Kentucky were interested in a live video mind-body activity program. GetActive-OA shows promise; however, the program and protocol require further NIH stage I refinement before formal efficacy testing (NIH model stage II). International Registered Report Identifier (IRRID) RR2-10.1016/j.conctc.2021.100720
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