Limitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15–20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects. Single-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle. Forty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated. HTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training. German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

中文翻译：

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与运动相比，热浴作为抑郁症常规护理的附加治疗的效果和可行性：一项随机对照试点研究


当前抑郁症治疗的局限性突出表明需要一种立即可用、易于实施且患者高度接受的附加治疗方案。温热浴 (HTB) 是浴疗的一种形式，即将头部浸入 40 °C 的热水池或浴缸中 15-20 分钟。先前的一项研究表明，在常规抑郁症护理中添加 HTB 可以产生抗抑郁作用。在大学门诊进行的单中心、开放标签、随机对照、为期 8 周的平行组试点研究。招募了 45 名病情稳定的中度抑郁症门诊患者，其 17 项汉密尔顿抑郁量表 (HAM-D) 评分≥ 18，第 1 项（抑郁情绪）评分≥ 2。他们被随机分配到每周两次 HTB (n = 22) 或中等强度的体育锻炼计划 (PEP) (n = 23)。主要结果指标是 HAM-D 总分从基线 (T0) 到 2 周时间点 (T1) 的变化。进行线性回归分析，根据基线值进行调整，以评估对意向治疗（ITT）和符合方案（PP）原则的干预效果。根据 ITT（平均年龄 = 48.4 岁，SD = 11.3，平均 HAM-D 评分 = 21.7，SD = 3.2）对 45 名患者（HTB n = 22；PEP n = 23）进行分析。两周后 HAM-D 评分的基线调整平均差异为 4.3 分，有利于 HTB（p < 0.001）。 HTB 组对干预和随访的依从性要好得多（退出组有 2 人对 13 人）。根据协议分析仅显示 HTB 作为趋势的优越性 (p = 0.068)。没有发生与治疗相关的严重不良事件。主要局限性：PEP 组的退出人数（23 人中的 13 人）高于其他研究运动治疗抑郁症的试验。 由于辍学人数较多，ITT 分析中的效果可能被高估。 HTB 添加到常规护理中可能是一种快速、安全且易于使用的方法，可在 2 周后改善抑郁严重程度的临床相关性；它也适合运动训练有困难的人。研究开始前的德国临床试验注册中心（DRKS），注册号为 DRKS00011013（注册日期为 2016-09-19）。