Abstract：
BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs).
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.
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.
摘要：
背景：为了评估COMPASS的临床疗效，治疗师支持的数字疗法，用于减少长期身体健康状况（LTC）患者的心理困扰（焦虑/抑郁）。
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。
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。
