Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial
Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial
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DOI：
10.1016/s2215-0366(15)00122-4
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发表时间：
2015-08-01
影响因子：
64.3
通讯作者：
Frueh, B. Christopher
中科院分区：
文献类型：
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作者：
Egede, Leonard E.;Acierno, Ron;Frueh, B. Christopher
许多患有重度抑郁症的老年人，特别是退伍军人，无法获得循证心理治疗。远程医疗可以增加面临流动性、耻辱和地理隔离障碍的老年人获得最佳做法护理的机会。我们的目的是建立非劣效性的行为激活治疗的抑郁症提供通过远程医疗，以同一房间的照顾，主要是男性，老年veterinary.Methods在这个随机，对照，开放标签，非劣效性试验，我们招募退伍军人（年龄>= 58岁）符合DSM-IV标准的重度抑郁症，来自拉尔夫H约翰逊退伍军人事务医疗中心和四个相关的社区门诊，美国的诊所。我们排除了活跃的精神病或痴呆患者，那些既有自杀意念又有明确意图的人，以及那些有物质依赖的人。研究协调员随机分配参与者（1：1;块大小2-6;按种族分层;计算机生成的随机序列RGK）通过远程医疗或在同一房间进行8次抑郁症行为激活。根据老年抑郁量表（GDS）和贝克抑郁量表（Beck Depression Inventory），主要结局为治疗反应（BDI;定义为12个月时症状较基线减少50%）和DSM-IV临床医生版结构化临床访谈（定义为在12个月随访时不再被诊断为重度抑郁症），符合方案人群（完成至少4次治疗且完成所有结局测量的人群）。对评估结局的患者设盲。非劣效性界值为15%。该试验在ClinicalTrials.gov注册，编号NCT 00324701。结果在2007年4月1日至2011年7月31日期间，我们筛选了780名患者，研究协调员将参与者随机分配到远程医疗（120 [50%]）或同室治疗（121 [50%]）。我们在远程医疗组的符合方案分析中纳入了100名（83%）患者，在同一房间组中纳入了104名（86%）患者。根据GDS，远程医疗组（22例[22.45%，90%CI 15.52-29.38]患者）和同一病房组（21例[20.39%，90%CI 13.86-26.92]）的治疗反应无显著差异，绝对差异为2.06%（90%CI-7.46至11.58）。根据BDI的缓解也没有显著差异（远程医疗19例[24.05%，90%CI 16.14-31.96]患者;同一房间19例[23.17%，90%CI 15.51-30.83]），绝对差异为0.88%（90%CI-10.13至11.89）。对DSM-IV临床医生版结构化临床访谈的反应也没有显著差异（远程医疗组39例[43.33%，90%CI 34.74-51.93]，同室组46例[48.42%，90%CI 39.99-56.85]），差异为-5.09%（-17.13至6.95; p=0.487）。意向治疗人群的结果相似。MEM分析显示，BDI和GDS治疗轨迹随时间推移不存在显著差异。符合非劣效性标准。我们没有注意到任何不良事件。解释远程医疗提供的心理治疗的老年人与重性抑郁症并不劣于同室治疗。这一发现表明，基于证据的心理治疗可以通过家庭远程医疗提供，而无需修改，并且这种方法可用于克服与老年人亲自参加会议的距离和困难相关的护理障碍。
Background Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans.Methods In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged >= 58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701.Findings Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22.45%, 90% CI 15.52-29.38] patients) and same-room (21 [20.39%, 90% CI 13.86-26.92]) groups, with an absolute difference of 2.06% (90% CI -7.46 to 11.58). Response according to BDI also did not differ significantly (telemedicine 19 [24.05%, 90% CI 16.14-31.96] patients; same room 19 [23.17%, 90% CI 15.51-30.83]), with an absolute difference of 0.88% (90% CI -10.13 to 11.89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43.33%, 90% CI 34.74-51.93] patients in the telemedicine group and 46 [48.42%, 90% CI 39.99-56.85] in the same-room group), with a difference of -5.09% (-17.13 to 6.95; p=0.487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events.Interpretation Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults.