Single case experimental design

  • 文章类型: Journal Article
    背景:患有脊髓损伤(SCI)的个体可以经历加速的认知老化。Myokines(在收缩过程中从肌肉细胞释放的因子),例如脑源性神经营养因子(BDNF),被认为对认知有有益的影响。神经肌肉电刺激(NMES)被证明会引起肌细胞的大量释放。然而,NMES对认知功能的影响尚未研究。
    目的:提出一项临床试验的研究方案,评估NMES旨在改善认知和BDNF的作用。
    方法:将对15名患有L1神经级以上慢性SCI(伤后>12个月)的成年人进行重复的随机三阶段单病例实验设计(SCED),并进行连续多基线时间序列和单臂前瞻性试验。每周3天,共12周。
    主要终点是在基线阶段每周进行3次的认知表现(通过智能手机测试进行评估),随机持续时间为3至8周,12周的干预阶段,和随访阶段3周之后12周的无测量休息期。次要终点是在基线期之前测量的BDNF水平和认知表现的变化,干预前后以及12周随访后。
    结论:这将是首次研究12周NMES对SCI患者认知和BDNF水平的影响。SCED结果提供了有关个体治疗效果过程的信息,这些信息可能会指导未来的研究。
    背景:ClinicalTrials.gov(NCT05822297,12/01/2023)。
    BACKGROUND: Individuals with spinal cord injury (SCI) can experience accelerated cognitive aging. Myokines (factors released from muscle cells during contractions), such as brain-derived neurotrophic factor (BDNF), are thought to have beneficial effects on cognition. Neuromuscular electrical stimulation (NMES) was shown to elicit a large release of myokines. However, the effects of NMES on cognitive function have not been studied.
    OBJECTIVE: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF.
    METHODS: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks.
    UNASSIGNED: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up.
    CONCLUSIONS: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research.
    BACKGROUND: ClinicalTrials.gov (NCT05822297, 12/01/2023).
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  • 文章类型: Journal Article
    认知行为疗法(CBT)可以有效治疗普通人群的抑郁症,但缺乏针对卒中后失语症患者特定认知和沟通需求的CBT评估研究.我们旨在评估改良CBT干预措施改善抑郁症状的可行性和初步疗效。在10名参与者(6名男性,四名女性)患有中风后失语症和自我报告的抑郁症。参与者与临床神经心理学家一起完成了10次个人干预课程,并进行了为期4周的随访。主要结果是自我评估的抑郁症,次要结局包括观察者评估的抑郁和焦虑症状.视觉分析数据并对基线趋势进行统计学控制。通过分析征聘和保留率,解决了可行性,治疗适应,和保真度评级。三名参与者自我报告在干预阶段抑郁水平下降,这对两名参与者来说是持续的。另外四名参与者在后续阶段有所改善。其他人报告抑郁症状(6名参与者)和焦虑症状(7名参与者)持续改善。改良CBT在减少卒中后失语症的抑郁症状方面似乎是可行的,并且可能有效。随机对照试验是有必要的,并应考虑额外的治疗。
    Cognitive behavioural therapy (CBT) can effectively treat depression in the general population, but there is a lack of studies evaluating CBT tailored to specific cognitive and communication needs of individuals with post-stroke aphasia. We aimed to evaluate the feasibility and preliminary efficacy of a modified CBT intervention to ameliorate depressive symptoms. An ABA withdrawal/reversal single case design with concurrent multiple baselines (2.5, 4.5, or 6.5 weeks) was repeated across 10 participants (six male, four female) with post-stroke aphasia and self-reported depression. Participants completed 10 individual intervention sessions with a clinical neuropsychologist and a 4-week follow-up. The primary outcome was self-rated depression, and secondary outcomes included observer-rated symptoms of depression and anxiety. Data were analysed visually and statistically controlling for baseline trend. Feasibility was addressed by analysing recruitment and retention rates, treatment adaptations, and fidelity ratings. Three participants self-reported decreased depression levels during the intervention phase, which was sustained for two participants. Four additional participants improved during the follow-up phase. Close others reported sustained improvements in depressive symptoms (six participants) and anxiety symptoms (seven participants). Modified CBT appears feasible and potentially efficacious in reducing depressive symptoms in post-stroke aphasia. A randomized controlled trial is warranted, and should consider additional treatment sessions.
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  • 文章类型: Journal Article
    这项研究检查了新的理论驱动的语法干预原则的早期功效,渐变输入类型变化(GITV)。
    三个讲粤语的孩子,年龄在4;01至5;10岁之间,有口语困难,参加了这项单一基线参与者内单病例实验研究。通过集中刺激,孩子们总共接受了300次目标连续动词构造的教学片段,并在10个30至45分钟的时间内重铸。目标的30个示例包括前五个会话中每个会话中动词的低类型变化,其次是其余会话的高类型变化。
    视觉分析显示,所有儿童都提高了他们在目标构建中的表现,但没有提高探针中的控制词汇,表明治疗效果。在所有儿童中也观察到治疗效果的维持。在所有儿童中都观察到了对未经训练的结构的跨行为推广的积极结果。对其他结构较少的语言语境和叙事复述话语语境的概括很少,仅在一个孩子中观察到。
    初步证据表明GITV作为语法干预原则的早期疗效。建议在涉及发育性语言障碍儿童的未来研究中修改研究方法。
    UNASSIGNED: This study examined the early efficacy of a new theory-driven principle of grammar intervention, graduated input type variation (GITV).
    UNASSIGNED: Three Cantonese-speaking children, aged between 4;01 and 5;10, with oral language difficulties participated in this single baseline within-participant single case experimental study. The children received a total of 300 teaching episodes of the target serial verb construction via focused stimulation and recast over 10 30- to 45-minute sessions. The 30 exemplars of the target included low type variation of the verbs in each of the first five sessions, followed by high type variation in the remaining sessions.
    UNASSIGNED: Visual analysis revealed that all children improved their performance in the target construction but not the control vocabulary in the probes, suggesting a treatment effect. Maintenance of treatment effects was also observed in all children. Positive results in across-behaviour generalisation to the untrained construction were observed in all children. Generalisation to other less structured linguistic contexts and to the narrative retell discourse context was minimal and observed in one child only.
    UNASSIGNED: Preliminary evidence suggested early efficacy of GITV as a principle for grammar intervention. Modifications in the research methodology are recommended for future studies involving children with developmental language disorder.
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  • 文章类型: Journal Article
    本报告介绍了杰克的单个案例,一位67岁的老人因其令人痛苦的迫害妄想和高度的担忧而向我们的老年成人社区心理健康小组(OACMHT)求助。杰克还报告了学习困难和自闭症特征,虽然都没有得到正式诊断。
    从“感觉安全计划”“担忧”模块中进行的十次担忧干预用于减少杰克担心的时间,并增加他对有意义活动的参与。每周举行面对面会议,和杰克的兄弟一起当医生.根据杰克的学习偏好对干预进行了适应。采用AB单例实验设计,比较杰克在担忧测量方面的得分,偏执狂和妄想定罪,干预前后的健康和日常功能。
    结果表明,忧虑干预在临床上显著提高了杰克的所有指标得分。
    这是第一个已知的将担忧干预应用于老年人的报告。结果表明,干预措施可以在减少担忧和偏执方面有相当大的好处,在年龄较大和怀疑神经多样性的背景下。
    UNASSIGNED: This report presents the single case of Jack, a 67-year-old referred to our Older Adult Community Mental Health Team (OA CMHT) for his distressing persecutory delusion and high levels of worry. Jack also reported learning difficulties and autistic traits, although neither were formally diagnosed.
    UNASSIGNED: Ten sessions of worry intervention taken from The Feeling Safe Programme worry module were used to reduce Jack\'s time spent worrying and increase his engagement in meaningful activity. Weekly face-to-face sessions were held, with Jack\'s brother acting as a co-therapist. Adaptations to the intervention were made based on Jack\'s learning preferences. An AB single case experimental design was adopted to compare Jack\'s scores on measures of worry, paranoia and delusional conviction, and wellbeing and daily functioning before and after intervention.
    UNASSIGNED: Results demonstrate the worry intervention improved Jack\'s scores on all measures to a clinically significant degree.
    UNASSIGNED: This is the first known report of applying the worry intervention to an older adult. The results show the intervention can be of considerable benefit in terms of reducing worry and paranoia, in the context of both older age and suspected neurodiversity.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Clinical Trial, Phase I
    进行了I期研究,以使用研究操作的协议来检查考夫曼语音对语言协议的治疗有效性。据推测,由于治疗,发音准确性将提高,并且这些改善将在治疗停止后保持。
    使用单例实验设计来评估考夫曼语音对语言协议的有效性。这项研究包括四名确诊为儿童言语失用症的儿童。每个孩子接受12个单独的1小时治疗,每个疗程包括一个近似设置阶段和一个练习阶段。在治疗期间和治疗后时间点收集探针数据以测量治疗有效性和测量未治疗单词的变化。包括未经处理的(对照)声音,以测试所记录的发音准确性的改善是否可归因于考夫曼语音到语言协议。
    四个孩子中有两个表现出对干预和维持这些变化的反应,而剩下的两个孩子在没有改善的目标(治疗)单词的情况下表现出一些泛化。没有特定的儿童因素与积极的治疗结果明显相关。
    这项研究复制了早期试点研究的结果,并发现考夫曼语音对语言协议的可操作协议可有效提高一些儿童言语失用症儿童的发音准确性。需要使用进一步完善的治疗方案和更大的样本量进行额外的复制,以支持Kaufman语音到语言协议的临床使用建议。
    UNASSIGNED: A Phase I study was conducted to examine the treatment effectiveness of the Kaufman Speech to Language Protocol using a research-operationalised protocol. It was hypothesised that articulatory accuracy would improve as a result of the treatment and that these improvements would be maintained after treatment was discontinued.
    UNASSIGNED: A single case experimental design was used to evaluate the effectiveness of the Kaufman Speech to Language Protocol. Four children with a confirmed childhood apraxia of speech diagnosis were included in this study. Each child received 12 individual 1 hr treatment sessions that each consisted of an approximation setting phase and a practice phase. Probe data was collected during treatment and at post-treatment time points to measure treatment effectiveness and to measure changes in the untreated words. Untreated (control) sounds were included to test whether recorded improvements in articulatory accuracy could be attributed to the Kaufman Speech to Language Protocol.
    UNASSIGNED: Two of the four children demonstrated a response to the intervention and maintenance of these changes, while the two remaining children demonstrated some generalisation in the absence of improved target (treatment) words. No specific child factors were clearly associated with positive treatment outcomes.
    UNASSIGNED: This study replicated the findings of an earlier pilot study and found that the operationalised protocol for the Kaufman Speech to Language Protocol is effective in improving articulatory accuracy for some children with childhood apraxia of speech. Additional replication with a further refined treatment protocol and a larger sample size is needed to support a recommendation of clinical use of the Kaufman Speech to Language Protocol.
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  • 文章类型: Journal Article
    背景:斑秃(AA)是一种以脱发为特征的免疫疾病。AA患者报告社交焦虑水平较高。一种有可能减少AA患者社交焦虑的干预措施是基于正念的认知疗法(MBCT)。
    目的:我们的主要目的是调查MBCT是否能降低AA患者的社交焦虑。该研究还调查了MBCT是否可以减少抑郁症,一般焦虑,并提高AA患者的生活质量和特质正念。
    方法:5名AA患者参加了8个疗程的MBCT干预。采用多基线单组病例系列设计。每天从基线开始测量社交焦虑的照片测量,通过干预,跟进。标准化的特质正念问卷,社交焦虑,抑郁症,焦虑,生活质量在基线时完成,干预后,在4周的随访中。
    结果:所有参与者都完成了MBCT课程,但由于大量缺失数据,一名参与者被排除在具体特征分析之外.其余四名参与者显示,从基线到随访,社交焦虑的具体指标有所减少。这些影响在基线和随访之间更大,在基线和干预后之间。两名参与者在从基线到随访的健康标准方面表现出显着改善-他们还在两次会议之间经常在家中练习正念。
    结论:MBCT可有效降低AA患者的社交焦虑和改善健康。尽管这可能取决于参与者定期练习正念练习的程度。
    BACKGROUND: Alopecia areata (AA) is an immunological disorder characterised by hair loss. Individuals with AA report high levels of social anxiety. One intervention that holds potential for reducing social anxiety in individuals with AA is mindfulness-based cognitive therapy (MBCT).
    OBJECTIVE: Our key aim was to investigate whether MBCT reduces social anxiety in individuals with AA. The study also investigated whether MBCT reduces depression, general anxiety, and increases quality of life and increases trait mindfulness in individuals with AA.
    METHODS: Five participants with AA took part in an 8-session in-person MBCT intervention. A multiple-baseline single-group case series design was adopted. Idiographic measures of social anxiety were measured each day from baseline, through intervention, to follow-up. Standardised questionnaires of trait mindfulness, social anxiety, depression, anxiety, and quality of life were completed at baseline, post-intervention, and at 4-week follow-up.
    RESULTS: All participants completed the MBCT course, but one participant was excluded from the idiographic analysis due to a high amount of missing data. The remaining four participants demonstrated reductions in idiographic measures of social anxiety from baseline to follow-up. These effects were larger between baseline and follow-up, than between baseline and post-intervention. Two participants demonstrated significant improvement in standardised measures of wellbeing from baseline to follow-up - they also practised mindfulness most regularly at home between sessions.
    CONCLUSIONS: MBCT may be effective in reducing social anxiety and improving wellbeing in individuals with AA, although this might be dependent on the extent to which participants regularly practise mindfulness exercises.
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  • 文章类型: Journal Article
    背景:威廉姆斯综合征(WS-OMIM1940,孤儿数:Orpha904)是一种罕见的疾病,主要与智力障碍有关。威廉姆斯综合征患者患焦虑症的可能性是普通人群的8倍。治疗焦虑症的治疗方案仍然有限,尤其是非药物治疗。然而,已发现认知行为疗法(CBT)可有效治疗焦虑症,可用于智力障碍患者.
    目的:本文描述了一种方案,该方案基于针对罕见疾病设计的研究方法,基于对威廉姆斯综合征和焦虑症患者的数字支持来评估CBT计划的效率。
    方法:我们将招募5名威廉姆斯综合征和焦虑症患者。他们将参加9次CBT会议。参与者将使用数字应用程序对焦虑进行每日自我评估,这将允许生态和重复评估他们的焦虑。这个数字应用程序将为每个治疗会话提供支持。焦虑和生活质量将在计划之前和之后以及3个月的随访中进行外部评估。这是一个单病例干预研究设计,具有多个基线,暗示了判断标准的重复测量。本方案确保了较高的内部有效性,并将有助于确定对以后的临床试验的令人鼓舞的贡献。
    结果:参与者的招募和数据收集于2019年9月开始,我们预计研究结果将于2023年春季发布。
    结论:这项研究将允许评估基于数字支持的CBT计划治疗威廉姆斯综合征患者焦虑的效率。最后,该程序可以用作罕见疾病的非药物治疗的一个例子。
    背景:ClinicalTrials.govID:NCT03827525;https://clinicaltrials.gov/ct2/show/NCT03827525。
    DERR1-10.2196/44393。
    BACKGROUND: Williams syndrome (WS-OMIM 194050, orphaned number: Orpha 904) is a rare condition mostly associated with intellectual disability. People with Williams syndrome are 8 times more likely to have anxiety disorders than the general population. Therapeutic solutions to treat the anxiety remain limited, particularly nonpharmacological therapy. However, cognitive behavioral therapy (CBT) has been found efficacious in managing anxiety disorders and can be used for people with intellectual disability.
    OBJECTIVE: This paper describes a protocol to assess the efficiency of a CBT program based on digital support for people with Williams syndrome and anxiety based on a research methodology designed for rare diseases.
    METHODS: We will recruit 5 individuals with Williams syndrome and anxiety. They will participate in 9 CBT sessions. Participants will perform daily self-assessments of anxiety using a digital app, which will allow for ecological and repeated evaluation of their anxiety. This digital app will provide support for each therapy session. Anxiety and quality of life will be externally assessed before and after the program and at a 3-month follow-up. This is a single-case intervention research design with multiple baselines implying repeated measures of judgment criteria. The present protocol ensures high internal validity and will help identify encouraging contributions for later clinical trials.
    RESULTS: Participant recruitment and data collection began in September 2019, and we project that the study findings will be available for dissemination by spring 2023.
    CONCLUSIONS: This study will allow the assessment of the efficiency of a CBT program based on digital support to treat anxiety in people with Williams syndrome. Finally, the program could be used as an example of nonpharmacological therapy for rare diseases.
    BACKGROUND: ClinicalTrials.gov ID: NCT03827525; https://clinicaltrials.gov/ct2/show/NCT03827525.
    UNASSIGNED: DERR1-10.2196/44393.
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  • 文章类型: Systematic Review
    背景:单例实验设计(SCED)对于小的异质样品特别有用。尚未对它们在评估肌肉骨骼疾病的物理治疗干预措施中的作用进行系统审查。
    目标:系统地审查使用情况,目的,SCED对肌肉骨骼疾病的物理治疗干预的结果。
    方法:电子数据库和灰色文献,使用预定义的术语进行搜索。
    方法:对参加符合条件的SCED(个体或系列)的人类参与者的研究。
    方法:我们提取了研究特征,分析方法和结果,描述性地综合这些。我们使用RoBiN-T量表评估偏倚风险。
    结果:我们包括19个SCED,包括92名参与者,在设计上有很大的可变性,方法论,分析,并对条件和干预措施进行评估。95%的参与者对测试的干预反应良好。总体偏见风险很高,由于内部有效性差,特别是关于随机化,盲法,评估者之间的协议和治疗依从性的测量。在55%的研究中单独进行视觉分析。对提供者和参与者满意度的评估有限。
    结论:主要发现:SCED可能非常适合评估肌肉骨骼疾病的物理治疗干预措施,但迄今为止的研究中偏倚的风险很高。建议遵循SCED指南,以最大程度地降低偏倚风险并最大程度地提高临床实用性。
    BACKGROUND: Single Case Experimental Designs (SCEDs) are especially useful for small heterogeneous samples. Their role in evaluation of physiotherapy interventions for musculoskeletal conditions has not been systematically reviewed.
    OBJECTIVE: Systematically review use, purpose, and outcomes of SCEDs for physiotherapy interventions for musculoskeletal conditions.
    METHODS: Electronic databases and grey literature, searched using pre-defined terms.
    METHODS: Studies of human participants enrolled in eligible SCEDs (individual or a series).
    METHODS: We extracted study characteristics, analytic methods and results, synthesising these descriptively. We used RoBiN-T scale to assess risk of bias.
    RESULTS: We included 19 SCEDs comprising 92 participants, with wide variability in design, methodology, analysis and in conditions and interventions evaluated. 95% of participants responded favourably to the tested intervention. Overall risk of bias was high, due to poor internal validity, especially regarding randomisation, blinding, inter-rater agreement and measurement of treatment adherence. Visual analysis alone was performed in 55% of studies. Assessment of provider and participant satisfaction was limited.
    CONCLUSIONS: of key findings: SCEDs may be well-suited to evaluation of physiotherapy interventions for musculoskeletal conditions, but the risk of bias in studies to date is high. Following SCED guidelines to minimize the risk of bias and maximise clinical usefulness is recommended.
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  • 文章类型: Journal Article
    我们在服务前培训模式中检查了跨专业合作,该模式结合了三种治疗方法的合并:职业治疗,言语-语言病理学,和应用行为分析。我们研究了临床医师跨专业技能库的变化对自闭症谱系障碍儿童治疗结果的影响。三名获得许可的专业人员对各自专业的核心技术进行建模,以建立治疗自闭症儿童的技能演示基准标准。在参与者的单个病例实验设计中,在多个基线内,针对多个治疗师和儿童行为依次实施治疗阶段。治疗师的技能得到了提高,以显示出多种干预技术,以匹配主管的熟练程度。这些跨专业技能是及时有效地同时提供的。自闭症儿童的评估结果包括言语表达频率增加,在成人指导的互动中参与,视觉运动任务生产率,并改善了姿势对齐。研究表明,跨专业技术的综合培训增强了临床医生技能的多样性,同时系统地证明儿童在许多跨专业治疗目标上的改善。
    We examined interprofessional collaboration in a pre-service training model which incorporated the merging of three treatments: Occupational Therapy, Speech-Language Pathology, and Applied Behavior Analysis. We examined the effects of changes in the clinician interprofessional skill repertoire on therapeutic outcomes for children with Autism Spectrum Disorder. Three licensed professionals modeled core techniques from their respective professions to establish benchmark standards for skill demonstration in the treatment of children with autism. Treatment phases were implemented sequentially targeting multiple therapist and child behaviors within a multiple-baseline across participants\' single case experimental design. Therapist skills improved to show a diverse repertoire of intervention techniques to match supervisor proficiencies. These interprofessional skills were delivered simultaneously in a timely and efficient manner. Assessed outcomes for children with autism included increased frequency of verbalizations, engagement during adult-directed interactions, visual-motor task productivity, and improved postural alignment. The study suggests that integrated training across interprofessional techniques enhanced a diverse repertoire of clinician skills, while systematically demonstrating child improvement on many interprofessional treatment goals.
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