From Boulder to Stockholm in 70 Years: Single Case Experimental Designs in Clinical Research

Wicksell, Rikard K.; Simons, Laura E.; Gentili, Charlotte; De, Tamal Kumar; Tate, Robyn; Vohra, Sunita; Punja, Salima; Linton, Steven J.; Sniehotta, Falko F; Onghena, Patrick

doi:10.1007/s40732-020-00402-5

Cited by 46 publications

(35 citation statements)

References 74 publications

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“…Ideally, a thorough measurement of an intervention will consist of a combination of these measurement timelines. For example, a study could include objective, continuously collected measures of physical activity and movement metrics cataloged during VR sessions, brief questionnaires deployed daily to capture gradual changes and enable single case experimental design analyses [ 42 ], and a longer battery of questionnaires completed at specified time points (eg, baseline and 3-month follow-up) to assess changes over time from repeated VR exposure.…”

Section: Resultsmentioning

confidence: 99%

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management

et al. 2021

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Background Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

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Section: Resultsmentioning

confidence: 99%

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management

et al. 2021

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“…These designs rely on the continued observation of a unit (e.g., an individual, group, hospital) under different conditions of at least one manipulated variable for a predetermined period of time. As such, SCEDs are capable of establishing robust causal relationships and may provide high levels of evidence (for an overview and historical context see Vlaeyen et al, 2020). While the strengths of such designs are reflected in the growing interest (Hammond and Gast, 2010) and the development of guidelines (Tate et al, 2016), this methodology is still under-explored in the tinnitus field.…”

Section: Challenges and Future Directionsmentioning

confidence: 99%

Multidisciplinary Tinnitus Research: Challenges and Future Directions From the Perspective of Early Stage Researchers

Simões

Daoud

Shabbir

et al. 2021

Front. Aging Neurosci.

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Tinnitus can be a burdensome condition on both individual and societal levels. Many aspects of this condition remain elusive, including its underlying mechanisms, ultimately hindering the development of a cure. Interdisciplinary approaches are required to overcome long-established research challenges. This review summarizes current knowledge in various tinnitus-relevant research fields including tinnitus generating mechanisms, heterogeneity, epidemiology, assessment, and treatment development, in an effort to highlight the main challenges and provide suggestions for future research to overcome them. Four common themes across different areas were identified as future research direction: (1) Further establishment of multicenter and multidisciplinary collaborations; (2) Systematic reviews and syntheses of existing knowledge; (3) Standardization of research methods including tinnitus assessment, data acquisition, and data analysis protocols; (4) The design of studies with large sample sizes and the creation of large tinnitus-specific databases that would allow in-depth exploration of tinnitus heterogeneity.

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“…27 While a SCED trial may have limited generality due to the number of participants, synthesising results from several trials assessing individual responses to treatment can enhance external validity. 34 Moreover, the incorporation of generalisation measures in a SCED study can reveal whether the treatment effects beyond the primary and secondary outcome measures to influence relevant factors that are not directly targeted by the treatment. 31 Procedure Using a simple randomisation method, 35 three participants will be assigned to one of three different tiers in the baseline phase.…”

Section: Methodsmentioning

confidence: 99%

Efficacy of the iDBT-Pain skills training intervention to reduce emotional dysregulation and pain intensity in people with chronic pain: protocol for a single-case experimental design with multiple baselines

et al. 2021

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IntroductionDifficulties in emotional regulation are key to the development and maintenance of chronic pain. Recent evidence shows internet-delivered dialectic behaviour therapy (iDBT) skills training can reduce emotional dysregulation and pain intensity. However, further studies are needed to provide more definitive evidence regarding the efficacy of iDBT skills training in the chronic pain population.Methods and analysisA single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of a 4-week iDBT-Pain skills training intervention (iDBT-Pain intervention) to reduce emotional dysregulation and pain intensity in individuals with chronic pain. The iDBT-Pain intervention encompasses two components: (1) iDBT-Pain skills training sessions (iDBT-Pain sessions) and (2) the iDBT-Pain skills training web application (iDBT-Pain app). Three individuals with chronic pain will be recruited and randomly allocated to different baseline phases (5, 9 or 12 days). Following the baseline phase, participants will receive six 60–90 min iDBT-Pain sessions approximately 4 or 5 days apart, delivered by a psychologist via Zoom. To reinforce learnings from the iDBT-Pain sessions, participants will have unlimited use of the iDBT-Pain app. A 7-day follow-up phase (maintenance) will follow the intervention, whereby the iDBT-Pain sessions cease but the iDBT-Pain app is accessible. Emotional regulation, as the primary outcome measure, will be assessed using the Difficulties in Emotion Regulation Scale. Pain intensity, as the secondary outcome measure, will be assessed using a visual analogue scale. Generalisation measures will assess psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance. SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain.Ethics and disseminationThis trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals.Trial registration numberACTRN12620000604909.

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From Boulder to Stockholm in 70 Years: Single Case Experimental Designs in Clinical Research

Cited by 46 publications

References 74 publications

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management

Multidisciplinary Tinnitus Research: Challenges and Future Directions From the Perspective of Early Stage Researchers

Efficacy of the iDBT-Pain skills training intervention to reduce emotional dysregulation and pain intensity in people with chronic pain: protocol for a single-case experimental design with multiple baselines

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