Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.
Department of Psychiatry, Sunnybrook Research Institute, 2075 Bayview Ave., FG 16, Toronto, ON, M4N 3M5, USA.
J Neurol. 2022 Dec;269(12):6202-6210. doi: 10.1007/s00415-022-11295-5. Epub 2022 Aug 8.
An earlier follow-up study from the CogEx rehabilitation trial showed little change in symptoms of depression, anxiety and psychological distress during the first COVID-19 lockdown compared to pre-pandemic measurements. Here, we provide a second follow-up set of behavioral data on the CogEx sample.
This was an ancillary, longitudinal follow-up study in CogEx, a randomized controlled trial of exercise and cognitive rehabilitation in people with progressive MS involving 11 centres in North America and Europe. Only individuals impaired on the Symbol Digit Modalities Test (SDMT) were included. Participants repeated the COVID Impact survey administered approximately a year later and completed self-report measures of depression, anxiety and MS symptoms that had been obtained at the trial baseline and during the first COVID Impact survey. Participants who completed the second COVID Impact follow-up were included. To identify predictors of the participants' ratings of their mental and physical well-being, step-wise linear regression was conducted.
Of the 131 participants who completed the first COVID impact survey, 74 participants completed the second follow-up survey (mean age 52 (SD = 6.4) years, 62.2% female, mean disease duration 16.4 (SD = 9.0) years, median EDSS 6.0). Pandemic restrictions prevented data collection from sites in Denmark and England (n = 57). The average time between measurements was 11.4 (SD = 5.56) months. There were no significant differences in age, sex, EDSS, disease course and duration between those who participated in the current follow-up study (n = 74) and the group that could not (n = 57). One participant had COVID in the time between assessments. Participants now took a more negative view of their mental/psychological well-being (p = 0.0001), physical well-being (p = 0.0009) and disease course (p = 0.005) compared to their last assessment. Depression scores increased on the HADS-depression scale (p = 0.01) and now exceeded the clinically significant threshold of ≥ 8.0 for the first time. Anxiety scores on the HADS remained unchanged. Poorer mental well-being was predicted by HADS depression scores (p = 0.012) and a secondary-progressive disease course (p = 0.0004).
A longer follow-up period revealed the later onset of clinically significant depressive symptoms on the HADS and a decline in self-perceptions of mental and physical well-being associated with the COVID-19 pandemic relative to the first follow-up data point.
The trial was registered on September 20th 2018 at www.
gov having identifier NCT03679468. Registration was performed before recruitment was initiated.
CogEx 康复试验的早期随访研究表明，与大流行前的测量结果相比，在第一次 COVID-19 封锁期间，抑郁、焦虑和心理困扰的症状几乎没有变化。在这里，我们提供了 CogEx 样本的第二次随访行为数据。
这是 CogEx 的一项辅助性纵向随访研究，CogEx 是一项针对北美和欧洲 11 个中心的进展性多发性硬化症患者的运动和认知康复的随机对照试验。仅纳入符号数字模态测试 (SDMT) 受损的个体。参与者在大约一年后重复 COVID 影响调查，并完成了在试验基线和第一次 COVID 影响调查期间获得的抑郁、焦虑和 MS 症状的自我报告测量。完成第二次 COVID 影响随访的参与者被纳入。为了确定参与者对其心理和身体健康的评分的预测因素，进行了逐步线性回归。
在完成第一次 COVID 影响调查的 131 名参与者中，有 74 名参与者完成了第二次随访调查（平均年龄 52（SD=6.4）岁，62.2%为女性，平均疾病持续时间为 16.4（SD=9.0）年，中位 EDSS 为 6.0）。大流行限制阻止了丹麦和英国的站点进行数据收集（n=57）。两次测量之间的平均时间为 11.4（SD=5.56）个月。在参加当前随访研究（n=74）和无法参加的组（n=57）之间，年龄、性别、EDSS、疾病过程和持续时间无显着差异。一名参与者在评估期间感染了 COVID。与上次评估相比，参与者现在对他们的精神/心理健康（p=0.0001）、身体健康（p=0.0009）和疾病过程（p=0.005）的看法更为负面。HADS 抑郁量表的抑郁评分增加（p=0.01），并且首次超过了临床显著阈值≥8.0。HADS 焦虑评分保持不变。HADS 抑郁评分（p=0.012）和二级进展性疾病过程（p=0.0004）预测了较差的心理健康。
更长的随访时间揭示了 HADS 上临床显著抑郁症状的出现较晚，以及与第一次随访数据点相比，与 COVID-19 大流行相关的自我感知心理健康和身体健康的下降。
该试验于 2018 年 9 月 20 日在 www.clinicaltrials.gov 上注册，标识符为 NCT03679468。注册是在招募开始之前进行的。
