Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05498454
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-06
First Post:
2022-07-21
Brief Title:
Contribution of Online Stress and Pain Mindfulness Treatment to ACT Process Change and Outcomes in Chronic Pain
Sponsor:
Government of Jersey
Organization:
Government of Jersey
Study Overview
Official Title:
Differential Contributions of Online Stress and Pain-explicit Mindfulness Treatment Groups to Processes Patient Experience and Outcomes in Chronic Pain A Randomized Controlled Trial and Qualitative Analysis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mindfulness is a popular set of knowledge and practical techniques that can help people cope with stress It includes meditation practices everyday small practices to break and change usual habits as well as understanding and developing competencies to be more aware of thoughts emotions and physical sensations Mindfulness can help not to excessively react to them or becoming distressed by these as well as pain
In persistent pain pain that lasts more than three months mindfulness is thought to improve depression quality of life and even how sore people feel
There are numerous versions of mindfulness and mindfulness-based therapies One approach Acceptance and Commitment Therapy ACT is based on science as opposed to religion or common sense ACT helps people to learn about and apply skills to cope with thoughts emotions and sensations without getting upset distracted or impeded by them It also assists people to develop the ability to set clear goals that matter in their life ACT evaluates successful outcomes in this areas called processes and how these link to changes in pain mood and stress However more puritan mindfulness courses tend to only focus on the latter
Research on mindfulness courses for chronic pain can show that people improve but not so well what changes in peoples experience and skills or how such skills are applied The investigators also know that pain sufferers who attend mindfulness courses for stress may say it is not so relevant to their pain difficulties
In this study the investigators want to explore how both mindfulness for stress and mindfulness for pain courses online contribute to
How specific areas of ACT and other mindfulness learning change
Ifhow these link with practical skills and any emotional or improvements in the participants quality of life use of medication or GP visits
Ifhow the above correlate with physiological stress responses such a heart rate variability To help us evaluate this the investigators will ask participants to complete scientifically accepted questionnaires and interview a proportion of participants Some may be invited to wear portable heart rate monitors The investigators will then use statistical methods and qualitative methods to evaluate change
This may help us with better supporting chronic pain sufferers with choices around mindfulness as a standalone or as part of attending intensive pain-coping programmes involving different professions
In persistent pain pain that lasts more than three months mindfulness is thought to improve depression quality of life and even how sore people feel
There are numerous versions of mindfulness and mindfulness-based therapies One approach Acceptance and Commitment Therapy ACT is based on science as opposed to religion or common sense ACT helps people to learn about and apply skills to cope with thoughts emotions and sensations without getting upset distracted or impeded by them It also assists people to develop the ability to set clear goals that matter in their life ACT evaluates successful outcomes in this areas called processes and how these link to changes in pain mood and stress However more puritan mindfulness courses tend to only focus on the latter
Research on mindfulness courses for chronic pain can show that people improve but not so well what changes in peoples experience and skills or how such skills are applied The investigators also know that pain sufferers who attend mindfulness courses for stress may say it is not so relevant to their pain difficulties
In this study the investigators want to explore how both mindfulness for stress and mindfulness for pain courses online contribute to
How specific areas of ACT and other mindfulness learning change
Ifhow these link with practical skills and any emotional or improvements in the participants quality of life use of medication or GP visits
Ifhow the above correlate with physiological stress responses such a heart rate variability To help us evaluate this the investigators will ask participants to complete scientifically accepted questionnaires and interview a proportion of participants Some may be invited to wear portable heart rate monitors The investigators will then use statistical methods and qualitative methods to evaluate change
This may help us with better supporting chronic pain sufferers with choices around mindfulness as a standalone or as part of attending intensive pain-coping programmes involving different professions
Detailed Description:
Detailed Description
Mindfulness can be defined operationally as Paying attention on purpose in the present moment and non-judgmentally
Evidence-based often referred to as secular mindfulness has seen an exponentially increasing interest in the scientific literature and the estimated number of published scientific journals has recently been reported to have grown from one single journal in 1982 to 667 scientific publications in 2016 and in excess of 30000 Media Pieces in Newspapers
However there are unknowns around the mechanisms the vehicles of change by which mindfulness works These must be better understood in order to avoid continued professional and public misinformation poor research and ultimately potential harm to the end user Van Dam van Vugt et al 2018
ISSUES WITH AND IMPLICATIONS OF WHAT THE INVESTIGATORS CURRENTLY DEFINE AS MINDFULNESS AND ITS APPLICATION TO CHRONIC PAIN
Within the context of the exponential growth of interest in and research of mindfulness including in the treatment of chronic pain several factors have contributed to the consideration for the current project
1 The integration of mindfulness based interventions in gold-standard multidisciplinary treatments for chronic pain such as ACT
2 Researchers calls to improve intention to treat to better understand facets of what is understood to be mindfulness better targetting of and a more unified approach to mindfulness-change process variables - thus aiming to reduce treatment burden
3 There are relevant mindful mechanisms and processes specifically in chronic pain that have made a case from both the ACT and the more purist mindfulness research derived from group based interventions or meditation alone in chronic pain - and that are not currently typically or routinely included in mindfulness groups research for chronic pain
4 Methodological issues including
1 lack of clarity about providers competencies and requirements in chronic pain
2 arbitrary removal of essential components of a given intervention
3 often no active or waiting list control condition and
4 no consideration at all of utilising a theoretically valid and coherent process-measurement frameworks nor consideration for the teachers competencies requirements when delivering mindfulness courses to chronic pain patients
From reviewing the evidence quoted the research on mindfulness for chronic pain has exclusively utilised standardised mindfulness groups typically aimed at stress populations excluded less researched pain explicit contextually relevant to pain mindfulness group interventions ignored theoretically valid mindful-process measurement provided by frameworks such as the ACT framework or not controlled appropriately for significant confounding factors
This debate is increasingly important considering that recently published audit data suggests that mindfulness in one format or the other or as part of ACT-based multidisciplinary treatment is being provided regularly in pain management centres in the UK This has been leading possibly prematurely to discussion about providing training in mindfulness competencies for pain practitioners such as mindfulness enquiry or leading meditations which may lead in turn to implementing professional skills without sound targeted and theoretically evidenced rationale
METHODOLOGICAL ISSUES WITH CURRENT MINDFULNESS RESEARCH AND THE IMPROVEMENTS WITH THIS STUDY
The current research will therefore aim to address and control some of the currently reported methodological issues in research on group mindfulness based interventions MBIs including
Utilising a waiting list for the whole group as a control prior to randomisation This will act as a pseudo treatment-as-usual condition and will track key outcome and process measures across this time
Utilising two active interventions Mindfulness for Stress MfS and Mindfulness for Health-Mindfulness Based Pain Management MfH-MBPM with a standardised transparent comparable in content time and delivery process that can therefore be easily evaluated for adherence and treatment fidelity
Using established and matched teachers competence in line with UK Network standards for the intervention delivered
Utilising the same dosage and type of interventions groups with similar structure delivery times and requirements for practice utilising MfH-MBPM and MfS protocols teacher notes and processes that are standardised
Inter-rater reliability assessment of fidelity to the treatment provided
Using appropriate psychometric and qualitative analysis and targeting of explicit process-change
Reporting adverse side effects
Measures in line with IMMPACT recommendations for research on chronic pain
the investigators may also submit Ethics amendments to include Heart Variability Measurement in a proportion of the study cohort to have a biological correlate
Identified Risks Likelihood Potential ImpactOutcome Risk ManagementMitigating Factors
Practicing mindfulness meditation has been known to trigger distressing memories in patients with existing TraumaPTSD
Low
Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation Exclusion criteria for enrolling in the study will include those with pre-existing psychiatric comorbidities particularly TraumaPTSD conditions
As the investigators are recruiting from primary care GPs will be informed of this criteria as will patients themselves in their information packs
The researcher will be able to signpost participant to the relevant support services
Discussion of sensitive topics in interview has potential to cause distress to participant
Low Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation Offer to cease interview
Exclusion criteria as above
The researcher will be able to signpost participant to the relevant support services
Conflict between participants in group setting
Low Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation
The researcher will have the necessary training and experience in group facilitation to handle conflicts
Data collection interviews may possibly take place in an unfamiliar location with people not already known to the researcher
High
Researcher
Physical Injury or Psychological Harm Visit location prior to data collection to assess possible risks associated with built and social environment
Use this information to plan session
Identify back up at location or online preferably
Allow extra time to familiarise participants with research and environment
Researcher to have contact details and means of making timely contact with back up
Disclosure of information about poor practice
Low Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
Disclosure of unmet health or social care needs
Medium Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
Research participant in danger of harm to self or others
Low Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
STATISTICAL POWER This study will be a modification of a previous pilot test trial of a brief widely inclusive UK primary care setting McCracken Sato and Taylor 2013 to include the whole sample of participants acting as a waiting list control randomly allocated to two active treatment conditions In line with this study which was delivered in a population area of 119000 people power calculations were not completed nor were formal predictions of significant treatment effects This was on the basis that the same treatment format and in a community based sample had not been tried before and demonstrated of successful recruitment of 60 participants within a two-month period and reporting moderate effect sizes for the active condition Given the whole island population of Jersey NB this is United Kingdom Jersey - not US is estimated currently at 106000 power calculations will not be provided in this study as the sample size was deemed appropriate in the previous that also cited a number of studies with similar sample sizes and obtained from populations greater than Jersey
Plan for missing data to address situations where variables are reported as missing unavailable non-reported uninterpretable or considered missing because of data inconsistency or out-of-range results The investigators will utilise mean substitution for missing items or alternative substitution technique
The quantitative analysis will be also bolstered by a qualitative study
DESIGN AND SETTING A qualitative study involving semi-structured interviews will be held with a topic guide informed by the ACT psychological flexibility model and Days framework for mindfulness-relevant processes in chronic pain and based on mindfulness research improvement based on adaptations of Mindfulness Based Cognitive Therapy MBCT for chronic pain
Exclusion criteria in addition to quantitative study criteria
Non-completers participants who completed less than 68 course sessions Declined to take part in interviews
SAMPLING An opportunity sample from all patients invited to take part to the quantitative research aspect invited as part of the initial quantitative study informed consent process
We will invite all participants from the sample aiming from 10-15 participants from each the stress and pain version of the courses hence a total sample of 30 participants maximum and a target of 10 completed interviews for each intervention
NB This studys initial Ethics Submission was for a face to face project in February 2019 However due to Covid-19 and lack of funding the investigators requested and agreed Ethics amendments to go online These amendments were approved by the Jersey Healthcare Ethics Committee after submission on 24052022 their meeting on 26052022 and formal email of approval on 30052022
Mindfulness can be defined operationally as Paying attention on purpose in the present moment and non-judgmentally
Evidence-based often referred to as secular mindfulness has seen an exponentially increasing interest in the scientific literature and the estimated number of published scientific journals has recently been reported to have grown from one single journal in 1982 to 667 scientific publications in 2016 and in excess of 30000 Media Pieces in Newspapers
However there are unknowns around the mechanisms the vehicles of change by which mindfulness works These must be better understood in order to avoid continued professional and public misinformation poor research and ultimately potential harm to the end user Van Dam van Vugt et al 2018
ISSUES WITH AND IMPLICATIONS OF WHAT THE INVESTIGATORS CURRENTLY DEFINE AS MINDFULNESS AND ITS APPLICATION TO CHRONIC PAIN
Within the context of the exponential growth of interest in and research of mindfulness including in the treatment of chronic pain several factors have contributed to the consideration for the current project
1 The integration of mindfulness based interventions in gold-standard multidisciplinary treatments for chronic pain such as ACT
2 Researchers calls to improve intention to treat to better understand facets of what is understood to be mindfulness better targetting of and a more unified approach to mindfulness-change process variables - thus aiming to reduce treatment burden
3 There are relevant mindful mechanisms and processes specifically in chronic pain that have made a case from both the ACT and the more purist mindfulness research derived from group based interventions or meditation alone in chronic pain - and that are not currently typically or routinely included in mindfulness groups research for chronic pain
4 Methodological issues including
1 lack of clarity about providers competencies and requirements in chronic pain
2 arbitrary removal of essential components of a given intervention
3 often no active or waiting list control condition and
4 no consideration at all of utilising a theoretically valid and coherent process-measurement frameworks nor consideration for the teachers competencies requirements when delivering mindfulness courses to chronic pain patients
From reviewing the evidence quoted the research on mindfulness for chronic pain has exclusively utilised standardised mindfulness groups typically aimed at stress populations excluded less researched pain explicit contextually relevant to pain mindfulness group interventions ignored theoretically valid mindful-process measurement provided by frameworks such as the ACT framework or not controlled appropriately for significant confounding factors
This debate is increasingly important considering that recently published audit data suggests that mindfulness in one format or the other or as part of ACT-based multidisciplinary treatment is being provided regularly in pain management centres in the UK This has been leading possibly prematurely to discussion about providing training in mindfulness competencies for pain practitioners such as mindfulness enquiry or leading meditations which may lead in turn to implementing professional skills without sound targeted and theoretically evidenced rationale
METHODOLOGICAL ISSUES WITH CURRENT MINDFULNESS RESEARCH AND THE IMPROVEMENTS WITH THIS STUDY
The current research will therefore aim to address and control some of the currently reported methodological issues in research on group mindfulness based interventions MBIs including
Utilising a waiting list for the whole group as a control prior to randomisation This will act as a pseudo treatment-as-usual condition and will track key outcome and process measures across this time
Utilising two active interventions Mindfulness for Stress MfS and Mindfulness for Health-Mindfulness Based Pain Management MfH-MBPM with a standardised transparent comparable in content time and delivery process that can therefore be easily evaluated for adherence and treatment fidelity
Using established and matched teachers competence in line with UK Network standards for the intervention delivered
Utilising the same dosage and type of interventions groups with similar structure delivery times and requirements for practice utilising MfH-MBPM and MfS protocols teacher notes and processes that are standardised
Inter-rater reliability assessment of fidelity to the treatment provided
Using appropriate psychometric and qualitative analysis and targeting of explicit process-change
Reporting adverse side effects
Measures in line with IMMPACT recommendations for research on chronic pain
the investigators may also submit Ethics amendments to include Heart Variability Measurement in a proportion of the study cohort to have a biological correlate
Identified Risks Likelihood Potential ImpactOutcome Risk ManagementMitigating Factors
Practicing mindfulness meditation has been known to trigger distressing memories in patients with existing TraumaPTSD
Low
Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation Exclusion criteria for enrolling in the study will include those with pre-existing psychiatric comorbidities particularly TraumaPTSD conditions
As the investigators are recruiting from primary care GPs will be informed of this criteria as will patients themselves in their information packs
The researcher will be able to signpost participant to the relevant support services
Discussion of sensitive topics in interview has potential to cause distress to participant
Low Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation Offer to cease interview
Exclusion criteria as above
The researcher will be able to signpost participant to the relevant support services
Conflict between participants in group setting
Low Participant
Psychological Stress
Researcher
Anxiety about dealing with a complex situation
The researcher will have the necessary training and experience in group facilitation to handle conflicts
Data collection interviews may possibly take place in an unfamiliar location with people not already known to the researcher
High
Researcher
Physical Injury or Psychological Harm Visit location prior to data collection to assess possible risks associated with built and social environment
Use this information to plan session
Identify back up at location or online preferably
Allow extra time to familiarise participants with research and environment
Researcher to have contact details and means of making timely contact with back up
Disclosure of information about poor practice
Low Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
Disclosure of unmet health or social care needs
Medium Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
Research participant in danger of harm to self or others
Low Immediate urgent or prompt response may be required from service providers Ensure all verbal and written information about research indicates possible researcher response to disclosure
The researcher will be able to signpost participant to the relevant support services
STATISTICAL POWER This study will be a modification of a previous pilot test trial of a brief widely inclusive UK primary care setting McCracken Sato and Taylor 2013 to include the whole sample of participants acting as a waiting list control randomly allocated to two active treatment conditions In line with this study which was delivered in a population area of 119000 people power calculations were not completed nor were formal predictions of significant treatment effects This was on the basis that the same treatment format and in a community based sample had not been tried before and demonstrated of successful recruitment of 60 participants within a two-month period and reporting moderate effect sizes for the active condition Given the whole island population of Jersey NB this is United Kingdom Jersey - not US is estimated currently at 106000 power calculations will not be provided in this study as the sample size was deemed appropriate in the previous that also cited a number of studies with similar sample sizes and obtained from populations greater than Jersey
Plan for missing data to address situations where variables are reported as missing unavailable non-reported uninterpretable or considered missing because of data inconsistency or out-of-range results The investigators will utilise mean substitution for missing items or alternative substitution technique
The quantitative analysis will be also bolstered by a qualitative study
DESIGN AND SETTING A qualitative study involving semi-structured interviews will be held with a topic guide informed by the ACT psychological flexibility model and Days framework for mindfulness-relevant processes in chronic pain and based on mindfulness research improvement based on adaptations of Mindfulness Based Cognitive Therapy MBCT for chronic pain
Exclusion criteria in addition to quantitative study criteria
Non-completers participants who completed less than 68 course sessions Declined to take part in interviews
SAMPLING An opportunity sample from all patients invited to take part to the quantitative research aspect invited as part of the initial quantitative study informed consent process
We will invite all participants from the sample aiming from 10-15 participants from each the stress and pain version of the courses hence a total sample of 30 participants maximum and a target of 10 completed interviews for each intervention
NB This studys initial Ethics Submission was for a face to face project in February 2019 However due to Covid-19 and lack of funding the investigators requested and agreed Ethics amendments to go online These amendments were approved by the Jersey Healthcare Ethics Committee after submission on 24052022 their meeting on 26052022 and formal email of approval on 30052022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None