Randomized controlled trial of the ehavioral ntervention for increasing hysical ctivity in ultiple clerosis project: Secondary, patient-reported outcomes

随机对照试验 医学 焦虑 干预(咨询) 物理疗法 生活质量(医疗保健) 医院焦虑抑郁量表 萧条(经济学) 认知行为疗法 临床心理学 精神科 内科学 护理部 宏观经济学 经济
作者
Robert W. Motl,Brian M. Sandroff,Lara A. Pilutti,Gary Cutter,Roberto Aldunate,Ariel Kidwell-Chandler,Rachel E. Bollaert
出处
期刊:Contemporary Clinical Trials [Elsevier]
卷期号:125: 107056-107056 被引量:5
标识
DOI:10.1016/j.cct.2022.107056
摘要

We undertook a randomized controlled trial (RCT) that investigated the effectiveness of a theory-based, Internet-delivered, behavioral intervention focusing on physical activity promotion for immediate and sustained improvements in secondary, patient-reported outcomes (PROs) of function, symptoms, and quality of life (QOL) in multiple sclerosis (MS).Persons with MS (N = 318) were recruited from throughout the United States and randomized into behavioral intervention (n = 159) or attention/social contact control (n = 159) conditions. The conditions were administered over a 6-month period by persons who were uninvolved in screening, recruitment, random assignment, and outcome assessment. There was a 6-month follow-up period without intervention access/content. We collected PROs data every 6 months over the 12-month period. The PROs included validated measures of walking and cognitive function, symptoms of fatigue, depression, anxiety, pain, and sleep quality, and QOL. The data analysis involved a modified intent-to-treat approach using a linear mixed model in JMP Pro 16.0.There was a significant group by time interaction on Fatigue Severity Scale scores (p < .01) and physical subscale scores of the Modified Fatigue Impact Scale (p < .05). Scores on both measures decreased immediately after the 6-month period in the behavioral intervention compared with no change in the control condition, and this differential pattern of change was sustained over the 6-month follow-up. There were no group by time interactions on the other PROs.This study provides evidence for the effectiveness of a novel, widely scalable approach for physical activity promotion and fatigue management in persons with MS, yet this must be contextualized with the absence of improvements in the other PROs.
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