Mundt James C, Debrota David J, Greist John H
Healthcare Technology Systems, Inc., Madison, Wisconsin, USA.
Psychiatry (Edgmont). 2007 Mar;4(3):39-45.
To evaluate patients' self-reports of treatment efficacy with and without self-prompted memory aids regarding their clinical experiences obtained prior to treatment initiation.
Double-blind, placebo-controlled trial with variable expected duration placebo lead-in and washout.
Multisite (US) randomized clinical trial.
Seventy-four patients with initial or recurrent DSM-IV diagnosis of major depression with symptoms of at least four weeks duration. A minimum Clinical Global Impression of Severity rating of Moderately Depressed and a clinician 17-item Hamilton Rating Scale for Depression score of 15 or greater, with the depressed mood item score of at least 2 were required for study entry.
Patient global impression of improvement (PGI-I) ratings obtained using an interactive voice response (IVR) computer-automated telephone system prior to and following playback of impromptu patient recordings obtained prior to the start of treatment (MERET).
MERET PGI-I ratings differentiated the effects of drug treatment from placebo more effectively than did standard PGI-I ratings. The drug-placebo treatment effect size obtained using standard PGI-I ratings was 0.525, whereas the effect size with MERET PGI-I ratings was 0.612.
The enhanced drug-placebo separation appeared to be primarily due to increased patients' perceptions of drug treatment effectiveness. Patients perceiving the greatest degree of clinical improvement indicated more benefit from hearing the MERET recordings. MERET appears to be a viable method for enhancing patients' insights into the benefits of effective treatments by allowing them to use personal descriptions provided in their own words and voice.
评估患者在有无自我提示记忆辅助工具的情况下,对治疗开始前临床经历的治疗效果的自我报告。
双盲、安慰剂对照试验,有可变预期持续时间的安慰剂导入期和洗脱期。
多中心(美国)随机临床试验。
74例初次或复发的DSM-IV诊断为重度抑郁症且症状持续至少四周的患者。研究入组要求临床总体印象严重程度评分至少为中度抑郁,临床医生17项汉密尔顿抑郁量表评分15分或更高,且抑郁情绪项目评分至少为2分。
在播放治疗开始前获得的患者即席录音(MERET)之前和之后,使用交互式语音应答(IVR)计算机自动电话系统获得患者总体改善印象(PGI-I)评分。
与标准PGI-I评分相比,MERET PGI-I评分能更有效地区分药物治疗与安慰剂的效果。使用标准PGI-I评分获得的药物-安慰剂治疗效应大小为0.525,而使用MERET PGI-I评分的效应大小为0.612。
药物-安慰剂分离增强似乎主要是由于患者对药物治疗效果的认知增加。认为临床改善程度最大的患者表示,从听取MERET录音中获益更多。MERET似乎是一种可行的方法,通过让患者使用自己的语言和声音提供的个人描述,增强患者对有效治疗益处的认识。