Walter Uso, Pennig Stefan, Bleckmann Lothar, Röschmann-Doose Kristina, Wittig Thomas, Thomsen Jörn, Schlee Winfried
ENT Practice Walter & Zander, Duisburg, Germany.
context, Essen-Kettwig, Germany.
J Med Internet Res. 2025 Feb 18;27:e59575. doi: 10.2196/59575.
Tinnitus is the perception of sound without an external auditive stimulus and can be a severe burden for affected patients. Medical guidelines recommend cognitive behavioral therapy (CBT) for tinnitus treatment, which effectively improves tinnitus-related distress and anxiety.
This study investigates the outcome of a 9-month smartphone-based CBT for patients with tinnitus.
The randomized controlled clinical trial in this study investigates the efficacy of a smartphone-based CBT for 187 patients with chronic tinnitus over a 9-month treatment period. In the initial 3 months, a waiting list design was applied, and in the subsequent study phase, the data of both treatment groups were collectively analyzed. The scores on the Tinnitus Questionnaire (TQ); 9-item Patient Health Questionnaire (PHQ-9); 9-item Self-Efficacy, Optimism, Pessimism (SWOP-K9) questionnaire; and 20-item Perceived Stress Questionnaire (PSQ-20) were assessed as endpoints after 3 and 9 months of treatment.
We observed a statistically significant reduction in the tinnitus burden in patients who received the smartphone-based CBT intervention. Although no changes were observed initially in the TQ sum scores in the waiting control group (baseline mean, 37.8, SD 4.7; 3 months mean 37.5, SD 4.8; analysis of covariance [ANCOVA] P=.52), the scores significantly decreased once the app-based CBT had commenced. Data pooled from both groups revealed significant reduction in the TQ sum score by 12.49 (SD 1.44) (ANCOVA, P<.001) and 18.48 (SD 1.85) (ANCOVA, P<.001) points after 3 and 9 months, respectively, which was also clinically important. The calculated Cohen d was 1.38. Similarly, the scores on PSQ-20 (-9.14 points; ANCOVA, P<.001), PHQ-9 (-2.47 points; ANCOVA, P<.001), and SWOP-K9 (0.17 points; ANCOVA, P<.001) were significantly improved at the end of the therapy, with corresponding intermediate effect sizes after 9 months.
The data in our study provide evidence of statistically significant, clinically relevant, and continuous benefits of an app-based CBT intervention in patients with chronic tinnitus.
Deutsches Register Klinischer Studien DRKS00022973; https://drks.de/search/de/trial/DRKS00022973.
耳鸣是在没有外部听觉刺激的情况下产生的声音感知，对受影响的患者来说可能是沉重负担。医学指南推荐认知行为疗法（CBT）用于耳鸣治疗，该疗法能有效改善与耳鸣相关的痛苦和焦虑。
本研究调查基于智能手机的9个月CBT对耳鸣患者的治疗效果。
本随机对照临床试验调查了基于智能手机的CBT对187例慢性耳鸣患者在9个月治疗期内的疗效。在最初3个月，采用等待列表设计，在随后的研究阶段，对两个治疗组的数据进行综合分析。将耳鸣问卷（TQ）、9项患者健康问卷（PHQ - 9）、9项自我效能感、乐观、悲观（SWOP - K9）问卷以及20项感知压力问卷（PSQ - 20）的得分作为治疗3个月和9个月后的终点指标进行评估。
我们观察到接受基于智能手机的CBT干预的患者耳鸣负担有统计学意义的减轻。虽然等待对照组的TQ总分最初未观察到变化（基线均值37.8，标准差4.7；3个月均值37.5，标准差4.8；协方差分析[ANCOVA]P = 0.52），但基于应用程序的CBT开始后得分显著下降。两组汇总数据显示，3个月和9个月后TQ总分分别显著降低12.49（标准差1.44）（ANCOVA，P < 0.001）和18.48（标准差1.85）（ANCOVA，P < 0.001）分，这在临床上也具有重要意义。计算得出的科恩d值为1.38。同样，治疗结束时PSQ - 20（-9.14分；ANCOVA，P < 0.001）、PHQ - 9（-2.47分；ANCOVA，P < 0.001）和SWOP - K9（0.17分；ANCOVA，P < 0.001）的得分显著改善，9个月后有相应的中等效应量。
我们研究中的数据证明了基于应用程序的CBT干预对慢性耳鸣患者具有统计学显著、临床相关且持续的益处。
德国临床试验注册中心DRKS00022973；https://drks.de/search/de/trial/DRKS00022973 。
