Single-Case Experimental Design

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Negin Hesamshariati - One of the best experts on this subject based on the ideXlab platform.

  • the no worries trial efficacy of online dialectical behaviour therapy skills training for chronic pain idbt pain using a single case Experimental Design
    The Journal of Pain, 2021
    Co-Authors: Nell Normannott, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Chelsey R Wilks, Nancy Briggs
    Abstract:

    Abstract Emotion dysregulation frequently co-occurs with chronic pain, which in turn leads to heightened emotional and physical suffering. This cycle of association has prompted a recommendation for psychological treatment of chronic pain to target mechanisms for emotion regulation. The current trial addressed this need by investigating a new internet-delivered treatment incorporating emotional skills training from dialectical behavioural therapy (DBT). Using a Single-Case Experimental Design that is suited to heterogeneous populations and can demonstrate efficacy with a small sample, three participants with chronic pain were recruited. Participants received four weeks of online DBT skills training (iDBT-Pain intervention) which incorporated one-on-one sessions over Zoom and a web app. Results revealed compelling evidence for the intervention on the primary outcome of emotion dysregulation and were promising for the secondary outcome of pain intensity. Improvement was also identified on pre-and post-measures of depression, coping behaviours, sleep problems, wellbeing, and harm avoidance, indicating that the intervention may positively influence other factors related to chronic pain. Overall, the trial provides preliminary efficacy for the intervention to improve chronic pain. However, we recommend further investigation of the iDBT-Pain intervention, either in single case trials, which when conducted with scientific rigour may be aggregated to derive nomothetic conclusions, or in a group-comparison trial to compare with usual modes of treatment. Perspective: This trial advances understanding of emotion-focused treatment for chronic pain and provides evidence for a viable new technological treatment. Importantly, as an internet-delivered approach, the iDBT-Pain intervention is accessible to those with restricted mobility and remote communities where there are often limited psychological services for people with chronic pain. Trial registration: The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12620000604909)

  • 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
    BMJ Open, 2021
    Co-Authors: Nell Normannott, Chelsey Wilks, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Sylvia M Gustin
    Abstract:

    INTRODUCTION: Difficulties 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 ANALYSIS: A 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 DISSEMINATION: This trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620000604909.

  • evaluation of the effectiveness of a novel brain computer interface neuromodulative intervention to relieve neuropathic pain following spinal cord injury protocol for a single case Experimental Design with multiple baselines
    JMIR Research Protocols, 2020
    Co-Authors: Negin Hesamshariati, Toby Newtonjohn, Avinash Kumar Singh, Carlos Tirado A Cortes, Ashley Craig, James W Middleton, Mark P Jensen, Zina Trost, Chinteng Lin, Sylvia M Gustin
    Abstract:

    BACKGROUND Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. OBJECTIVE The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. METHODS We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a Single-Case Experimental Design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. RESULTS This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. CONCLUSIONS This clinical trial using Single-Case Experimental Design methodology has been Designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-Case Experimental Designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/20979.

  • evaluation of the effectiveness of a novel brain computer interface neuromodulative intervention to relieve neuropathic pain following spinal cord injury protocol for a single case Experimental Design with multiple baselines
    JMIR Research Protocols, 2020
    Co-Authors: Negin Hesamshariati, Toby Newtonjohn, Avinash Kumar Singh, Carlos Tirado A Cortes, Ashley Craig, James W Middleton, Mark P Jensen, Zina Trost, Chinteng Lin
    Abstract:

    Background: Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. Objective: The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. Methods: We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a Single-Case Experimental Design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. Results: This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. Conclusions: This clinical trial using Single-Case Experimental Design methodology has been Designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-Case Experimental Designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx

Nell Normannott - One of the best experts on this subject based on the ideXlab platform.

  • the no worries trial efficacy of online dialectical behaviour therapy skills training for chronic pain idbt pain using a single case Experimental Design
    The Journal of Pain, 2021
    Co-Authors: Nell Normannott, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Chelsey R Wilks, Nancy Briggs
    Abstract:

    Abstract Emotion dysregulation frequently co-occurs with chronic pain, which in turn leads to heightened emotional and physical suffering. This cycle of association has prompted a recommendation for psychological treatment of chronic pain to target mechanisms for emotion regulation. The current trial addressed this need by investigating a new internet-delivered treatment incorporating emotional skills training from dialectical behavioural therapy (DBT). Using a Single-Case Experimental Design that is suited to heterogeneous populations and can demonstrate efficacy with a small sample, three participants with chronic pain were recruited. Participants received four weeks of online DBT skills training (iDBT-Pain intervention) which incorporated one-on-one sessions over Zoom and a web app. Results revealed compelling evidence for the intervention on the primary outcome of emotion dysregulation and were promising for the secondary outcome of pain intensity. Improvement was also identified on pre-and post-measures of depression, coping behaviours, sleep problems, wellbeing, and harm avoidance, indicating that the intervention may positively influence other factors related to chronic pain. Overall, the trial provides preliminary efficacy for the intervention to improve chronic pain. However, we recommend further investigation of the iDBT-Pain intervention, either in single case trials, which when conducted with scientific rigour may be aggregated to derive nomothetic conclusions, or in a group-comparison trial to compare with usual modes of treatment. Perspective: This trial advances understanding of emotion-focused treatment for chronic pain and provides evidence for a viable new technological treatment. Importantly, as an internet-delivered approach, the iDBT-Pain intervention is accessible to those with restricted mobility and remote communities where there are often limited psychological services for people with chronic pain. Trial registration: The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12620000604909)

  • 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
    BMJ Open, 2021
    Co-Authors: Nell Normannott, Chelsey Wilks, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Sylvia M Gustin
    Abstract:

    INTRODUCTION: Difficulties 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 ANALYSIS: A 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 DISSEMINATION: This trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620000604909.

Jina Suh - One of the best experts on this subject based on the ideXlab platform.

  • the no worries trial efficacy of online dialectical behaviour therapy skills training for chronic pain idbt pain using a single case Experimental Design
    The Journal of Pain, 2021
    Co-Authors: Nell Normannott, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Chelsey R Wilks, Nancy Briggs
    Abstract:

    Abstract Emotion dysregulation frequently co-occurs with chronic pain, which in turn leads to heightened emotional and physical suffering. This cycle of association has prompted a recommendation for psychological treatment of chronic pain to target mechanisms for emotion regulation. The current trial addressed this need by investigating a new internet-delivered treatment incorporating emotional skills training from dialectical behavioural therapy (DBT). Using a Single-Case Experimental Design that is suited to heterogeneous populations and can demonstrate efficacy with a small sample, three participants with chronic pain were recruited. Participants received four weeks of online DBT skills training (iDBT-Pain intervention) which incorporated one-on-one sessions over Zoom and a web app. Results revealed compelling evidence for the intervention on the primary outcome of emotion dysregulation and were promising for the secondary outcome of pain intensity. Improvement was also identified on pre-and post-measures of depression, coping behaviours, sleep problems, wellbeing, and harm avoidance, indicating that the intervention may positively influence other factors related to chronic pain. Overall, the trial provides preliminary efficacy for the intervention to improve chronic pain. However, we recommend further investigation of the iDBT-Pain intervention, either in single case trials, which when conducted with scientific rigour may be aggregated to derive nomothetic conclusions, or in a group-comparison trial to compare with usual modes of treatment. Perspective: This trial advances understanding of emotion-focused treatment for chronic pain and provides evidence for a viable new technological treatment. Importantly, as an internet-delivered approach, the iDBT-Pain intervention is accessible to those with restricted mobility and remote communities where there are often limited psychological services for people with chronic pain. Trial registration: The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12620000604909)

  • 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
    BMJ Open, 2021
    Co-Authors: Nell Normannott, Chelsey Wilks, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Sylvia M Gustin
    Abstract:

    INTRODUCTION: Difficulties 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 ANALYSIS: A 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 DISSEMINATION: This trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620000604909.

Sylvia M Gustin - One of the best experts on this subject based on the ideXlab platform.

  • 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
    BMJ Open, 2021
    Co-Authors: Nell Normannott, Chelsey Wilks, Negin Hesamshariati, Jessica Schroeder, Jina Suh, Mary Czerwinski, Sylvia M Gustin
    Abstract:

    INTRODUCTION: Difficulties 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 ANALYSIS: A 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 DISSEMINATION: This trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620000604909.

  • evaluation of the effectiveness of a novel brain computer interface neuromodulative intervention to relieve neuropathic pain following spinal cord injury protocol for a single case Experimental Design with multiple baselines
    JMIR Research Protocols, 2020
    Co-Authors: Negin Hesamshariati, Toby Newtonjohn, Avinash Kumar Singh, Carlos Tirado A Cortes, Ashley Craig, James W Middleton, Mark P Jensen, Zina Trost, Chinteng Lin, Sylvia M Gustin
    Abstract:

    BACKGROUND Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. OBJECTIVE The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. METHODS We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a Single-Case Experimental Design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. RESULTS This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. CONCLUSIONS This clinical trial using Single-Case Experimental Design methodology has been Designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-Case Experimental Designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/20979.

Leora R. Cherney - One of the best experts on this subject based on the ideXlab platform.