Engelke Milena, Simões Jorge, Vogel Carsten, Schoisswohl Stefan, Schecklmann Martin, Wölflick Stella, Pryss Rüdiger, Probst Thomas, Langguth Berthold, Schlee Winfried
Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.
PLOS Digit Health. 2023 Jan 18;2(1):e0000183. doi: 10.1371/journal.pdig.0000183. eCollection 2023 Jan.
Tinnitus affects a considerable part of the population and develops into a severe disorder in some sufferers. App-based interventions are able to provide low-threshold, cost-effective, and location-independent care for tinnitus patients. Therefore, we developed a smartphone app combining structured counseling with sound therapy and conducted a pilot study to evaluate treatment compliance and symptom improvement (trial registration: DRKS00030007). Outcome variables were Ecological Momentary Assessment (EMA) measured tinnitus distress and loudness and Tinnitus Handicap Inventory (THI) at baseline and final visit. A multiple-baseline design with a baseline phase (only EMA) followed by an intervention phase (EMA and intervention) was applied. 21 patients with chronic tinnitus (≥ 6 months) were included. Overall compliance differed between modules (EMA usage: 79% of days, structured counseling: 72%, sound therapy: 32%). The THI score improved from baseline to final visit indicating a large effect (Cohens d = 1.1). Tinnitus distress and loudness did not improve significantly from baseline phase to the end of intervention phase. However, 5 of 14 (36%) improved clinically meaningful in tinnitus distress (ΔDistress ≥ 10) and 13 of 18 (72%) in THI score (ΔTHI ≥ 7). The positive relationship between tinnitus distress and loudness weakened over the course of the study. A trend but no level effect for tinnitus distress could be demonstrated by a mixed effect model. The improvement in THI was strongly associated with the improvement scores in EMA of tinnitus distress (r = -0.75; 0.86). These results indicate that app-based structured counseling combined with sound therapy is feasible, has an impact on tinnitus symptoms and reduces distress for several patients. In addition, our data suggest that EMA could be used as a measurement tool to detect changes in tinnitus symptoms in clinical trials as has already been shown in other areas of mental health research.
耳鸣影响着相当一部分人群，在一些患者中会发展成一种严重的疾病。基于应用程序的干预措施能够为耳鸣患者提供低门槛、经济高效且不受地点限制的护理。因此，我们开发了一款将结构化咨询与声音疗法相结合的智能手机应用程序，并进行了一项试点研究，以评估治疗依从性和症状改善情况（试验注册号：DRKS00030007）。结局变量为基线和末次访视时通过生态瞬时评估（EMA）测量的耳鸣困扰和响度以及耳鸣 handicap 量表（THI）。采用多基线设计，包括一个基线期（仅EMA），随后是一个干预期（EMA和干预）。纳入了21例慢性耳鸣（≥6个月）患者。各模块的总体依从性有所不同（EMA使用情况：79%的天数，结构化咨询：72%，声音疗法：32%）。THI评分从基线到末次访视有所改善，表明效果显著（科恩d值 = 1.1）。从基线期到干预期结束，耳鸣困扰和响度没有显著改善。然而，14例中有5例（36%）耳鸣困扰有临床意义的改善（困扰变化量≥10），18例中有13例（72%）THI评分改善（THI变化量≥7）。在研究过程中，耳鸣困扰和响度之间的正相关关系减弱。混合效应模型显示耳鸣困扰有一个趋势但无水平效应。THI的改善与耳鸣困扰EMA的改善评分密切相关（r = -0.75；0.86）。这些结果表明，基于应用程序的结构化咨询与声音疗法相结合是可行的，对耳鸣症状有影响，并减轻了部分患者的困扰。此外，我们的数据表明，EMA可作为一种测量工具，用于在临床试验中检测耳鸣症状的变化，正如在其他心理健康研究领域已经显示的那样。
