METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation.
RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm.
CONCLUSIONS: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating.
BACKGROUND: NCT04535778.
方法:一项从LTC慈善机构招募的双臂随机对照试验。与他们的LTC(s)相关的焦虑和/或抑郁症状的参与者被随机分配(通过独立管理员隐藏分配)到COMPASS(访问11个定制模块加上五个30分钟的治疗师支持会议)或标准慈善支持(SCS)。评估是在线预随机完成的,在随机化后6周和12周。主要结果是患者健康问卷焦虑和抑郁量表;PHQ-ADS在12周测量。分析使用意向治疗原则,并使用线性混合效应模型估计调整后的平均差异。数据分析师对小组分配视而不见。
结果:194名参与者被随机分配到COMPASS(N=94)或SCS(N=100)。12周时,COMPASS组的平均心理困扰水平比SCS低6.82(95%置信区间;CI4.55-9.10)分(p<0.001)(标准化平均差0.71(95%CI0.48-0.95)).COMPASS组还对包括抑郁症在内的次要结局显示出中等显著的治疗效果,焦虑和疾病相关的痛苦以及对功能和生活质量的小的显著影响。两组的不良事件发生率相当。在SCS组的2.2%中观察到12周时的痛苦恶化,并且没有COMPASS手臂的参与者。
结论:与SCS相比,COMPASS数字治疗与最少的治疗师输入减少心理困扰在治疗后(12周)。COMPASS为卫生服务提供了一个潜在的可扩展实施模型,但它在这些环境中的转化需要进一步评估。
背景:NCT04535778。