Center for Psychotherapy Research, University of Heidelberg, Bergheimer Str. 54, 69115 Heidelberg, Germany.
Contemp Clin Trials. 2013 Nov;36(2):327-37. doi: 10.1016/j.cct.2013.08.005. Epub 2013 Aug 23.
Major depression is a highly prevalent, disabling disorder associated with loss of quality of life and large economic burden for the society. Depressive disorders often follow a chronic or recurrent course. The risk of relapses increases with each additional episode. The internet-deliverable intervention strategy SUMMIT (SUpportive Monitoring and Disease Management over the InTernet) for patients with recurrent depression has been developed with the main objectives to prolong symptom-free phases and to shorten symptom-loaden phases. This paper describes the study design of a six-sites, three-arm, randomized clinical trial intended to evaluate the efficacy of this novel strategy compared to treatment as usual (TAU). Two hundred thirty six patients who had been treated for their (at least) third depressive episode in one of the six participating psychiatric centers were randomized into one of three groups: 1) TAU plus a twelve-month SUMMIT program participation with personal support or 2) TAU plus a twelve-month SUMMIT program participation without personal support, or 3) TAU alone. Primary outcome of this study is defined as the number of "well weeks" over 24months after index treatment assessed by blind evaluators based on the Longitudinal Interval Follow-Up Evaluation. If efficacious, the low monetary and nonmonetary expenditures of this automated, yet individualized intervention may open new avenues for providing an acceptable, convenient, and affordable long-term disease management strategy to people with a chronic mental condition such as recurrent depression.
重度抑郁症是一种高发性、致残性疾病,会降低生活质量,并给社会带来巨大的经济负担。抑郁障碍常常呈慢性或复发性病程。每次发作后,复发的风险都会增加。SUMMIT 是一种针对复发性抑郁症患者的互联网可交付干预策略,其主要目标是延长无症状期并缩短症状期。本文描述了一项六中心、三臂、随机临床试验的研究设计,旨在评估这种新策略与常规治疗(TAU)相比的疗效。236 名患者曾在六家参与研究的精神科中心之一接受过至少三次抑郁症治疗,他们被随机分为三组:1)TAU 加为期 12 个月的 SUMMIT 项目参与,包括个人支持或 2)TAU 加为期 12 个月的 SUMMIT 项目参与,但不包括个人支持,或 3)TAU 单独治疗。本研究的主要结局定义为根据纵向间隔随访评估(Longitudinal Interval Follow-Up Evaluation),在指数治疗后 24 个月内盲法评估者评估的“良好周数”。如果有效,这种自动化但个性化的干预措施的低经济和非经济支出可能为患有慢性精神疾病(如复发性抑郁症)的人提供一种可接受、方便和负担得起的长期疾病管理策略开辟新途径。