Maitê Schneider, Carolina Prietto Ferrazza, Roberta Francieli da Silva Bomber, Felipe Picon, Diego Luiz Rovaris, Paulo Roberto Stefani Sanches, Danton Pereira, André Russowsky Brunoni, Joan A Camprodon, Wolnei Caumo, Claiton Henrique Dotto Bau, Eugenio Horacio Grevet, Luis Augusto Rohde, Douglas Teixeira Leffa
{"title":"提高成人ADHD患者的目标实现:调谐试验中经颅直流电刺激的参与者中心评价。","authors":"Maitê Schneider, Carolina Prietto Ferrazza, Roberta Francieli da Silva Bomber, Felipe Picon, Diego Luiz Rovaris, Paulo Roberto Stefani Sanches, Danton Pereira, André Russowsky Brunoni, Joan A Camprodon, Wolnei Caumo, Claiton Henrique Dotto Bau, Eugenio Horacio Grevet, Luis Augusto Rohde, Douglas Teixeira Leffa","doi":"10.1177/10870547251341595","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Few trials in ADHD incorporate participant-centered outcomes that evaluate the impact of interventions on meaningful life activities. Additionally, in psychiatry, the translation of changes in symptom rating scales into meaningful impacts on participants' lives has been questioned. The Transcranial Direct Current Stimulation (tDCS) for the Treatment of Inattention Symptoms in Adult Patients with ADHD (TUNED) trial demonstrated improved inattention symptoms, assessed using a clinician-administrated scale, after a 4-week treatment with daily home-based tDCS in adults with ADHD. Here, our primary objective was to evaluate the impact of tDCS in ADHD using a participant-centered and clinically relevant outcome.</p><p><strong>Method: </strong>We analyzed data from the TUNED trial (ClinicalTrials.gov Identifier: NCT04003740), a randomized, double-blind, parallel, sham-controlled study testing tDCS in adults with ADHD. At the baseline assessment, all participants were instructed to select up to three goals they desired to achieve during the trial period. The goals had to be specific, measurable, achievable, relevant, and time-bound. Our main outcome was the number of goals achieved at the end of the intervention.</p><p><strong>Results: </strong>Of the 64 participants randomized, 55 completed the trial and were included in the analyses (26 [47%] inattentive presentation and 29 [53%] combined presentation; mean (<i>SD</i>) age, 38.1 [9.8] years; 40% women). In the active tDCS group (<i>n</i> = 25), eight participants (32%) achieved one goal, 5 (20%) achieved two goals, 3 (12%) achieved all three goals, and 9 (36%) achieved no goals. In the sham tDCS group (<i>n</i> = 30), 3 (10%) participants achieved one goal, 3 (10%) achieved two goals, 3 (10%) achieved all three goals, and 21 (70%) achieved no goals. Ordinal logistic regression analyses showed that participants in the active tDCS group were more likely to achieve a higher number of goals compared to those in the tDCS sham group (OR = 3.05, 95% CI [1.06, 8.75], <i>p</i> = .03]).</p><p><strong>Conclusion: </strong>This study demonstrated that tDCS can significantly enhance the ability to achieve personal goals in adults with ADHD. 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The goals had to be specific, measurable, achievable, relevant, and time-bound. Our main outcome was the number of goals achieved at the end of the intervention.</p><p><strong>Results: </strong>Of the 64 participants randomized, 55 completed the trial and were included in the analyses (26 [47%] inattentive presentation and 29 [53%] combined presentation; mean (<i>SD</i>) age, 38.1 [9.8] years; 40% women). In the active tDCS group (<i>n</i> = 25), eight participants (32%) achieved one goal, 5 (20%) achieved two goals, 3 (12%) achieved all three goals, and 9 (36%) achieved no goals. In the sham tDCS group (<i>n</i> = 30), 3 (10%) participants achieved one goal, 3 (10%) achieved two goals, 3 (10%) achieved all three goals, and 21 (70%) achieved no goals. 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引用次数: 0
摘要
目的:很少有ADHD试验纳入以参与者为中心的结果来评估干预对有意义的生活活动的影响。此外,在精神病学中,将症状评定量表的变化转化为对参与者生活有意义的影响一直受到质疑。经颅直流电刺激(tDCS)治疗成年ADHD患者注意力不集中症状(TUNED)试验表明,在对成年ADHD患者进行为期4周的每日家庭tDCS治疗后,注意力不集中症状得到改善,使用临床给药量表进行评估。在这里,我们的主要目的是通过以参与者为中心和临床相关的结果来评估tDCS对ADHD的影响。方法:我们分析了来自tune试验(ClinicalTrials.gov识别码:NCT04003740)的数据,该试验是一项随机、双盲、平行、假对照的研究,用于测试成人ADHD患者的tDCS。在基线评估中,所有参与者被要求选择三个他们希望在试验期间实现的目标。目标必须是具体的、可衡量的、可实现的、相关的和有时间限制的。我们的主要结果是在干预结束时实现的目标数量。结果:在随机分配的64名受试者中,55名完成了试验并被纳入分析(26名[47%]疏忽陈述,29名[53%]合并陈述;平均(SD)年龄为38.1[9.8]岁;40%的女性)。在积极tDCS组(n = 25)中,8名参与者(32%)实现了一个目标,5名(20%)实现了两个目标,3名(12%)实现了三个目标,9名(36%)没有实现目标。在假性tDCS组(n = 30)中,3名(10%)参与者实现了一个目标,3名(10%)参与者实现了两个目标,3名(10%)参与者实现了三个目标,21名(70%)参与者没有实现目标。有序逻辑回归分析显示,与假手术组相比,活动tDCS组的参与者更有可能实现更多的目标(OR = 3.05, 95% CI [1.06, 8.75], p = .03])。结论:本研究表明,tDCS可以显著提高成人ADHD患者实现个人目标的能力。通过采用以参与者为中心的方法,我们的研究结果不仅支持tDCS作为一种有希望的ADHD治疗方法,而且与日益强调的个性化医疗和临床相关的、参与者报告的临床研究结果相一致。
Enhancing Goal Achievement in Adults With ADHD: A Participant-Centered Evaluation of Transcranial Direct Current Stimulation From the TUNED Trial.
Objective: Few trials in ADHD incorporate participant-centered outcomes that evaluate the impact of interventions on meaningful life activities. Additionally, in psychiatry, the translation of changes in symptom rating scales into meaningful impacts on participants' lives has been questioned. The Transcranial Direct Current Stimulation (tDCS) for the Treatment of Inattention Symptoms in Adult Patients with ADHD (TUNED) trial demonstrated improved inattention symptoms, assessed using a clinician-administrated scale, after a 4-week treatment with daily home-based tDCS in adults with ADHD. Here, our primary objective was to evaluate the impact of tDCS in ADHD using a participant-centered and clinically relevant outcome.
Method: We analyzed data from the TUNED trial (ClinicalTrials.gov Identifier: NCT04003740), a randomized, double-blind, parallel, sham-controlled study testing tDCS in adults with ADHD. At the baseline assessment, all participants were instructed to select up to three goals they desired to achieve during the trial period. The goals had to be specific, measurable, achievable, relevant, and time-bound. Our main outcome was the number of goals achieved at the end of the intervention.
Results: Of the 64 participants randomized, 55 completed the trial and were included in the analyses (26 [47%] inattentive presentation and 29 [53%] combined presentation; mean (SD) age, 38.1 [9.8] years; 40% women). In the active tDCS group (n = 25), eight participants (32%) achieved one goal, 5 (20%) achieved two goals, 3 (12%) achieved all three goals, and 9 (36%) achieved no goals. In the sham tDCS group (n = 30), 3 (10%) participants achieved one goal, 3 (10%) achieved two goals, 3 (10%) achieved all three goals, and 21 (70%) achieved no goals. Ordinal logistic regression analyses showed that participants in the active tDCS group were more likely to achieve a higher number of goals compared to those in the tDCS sham group (OR = 3.05, 95% CI [1.06, 8.75], p = .03]).
Conclusion: This study demonstrated that tDCS can significantly enhance the ability to achieve personal goals in adults with ADHD. By using a participant-centered approach, our findings not only support tDCS as a promising treatment for ADHD but also align with the growing emphasis on personalized medicine and clinically relevant, participant-reported outcomes in clinical research.
期刊介绍:
Journal of Attention Disorders (JAD) focuses on basic and applied science concerning attention and related functions in children, adolescents, and adults. JAD publishes articles on diagnosis, comorbidity, neuropsychological functioning, psychopharmacology, and psychosocial issues. The journal also addresses practice, policy, and theory, as well as review articles, commentaries, in-depth analyses, empirical research articles, and case presentations or program evaluations.