Clinical trial NCT05498454: Contribution of Online Stress and Pain Mindfulness Treatment to ACT Process Change and Outcomes in Chronic Pain
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: mindfulness
chronic pain
pain
Acceptance and Commitment Therapy
Lead sponsor: Government of Jersey
Sponsor class: OTHER_GOV
Collaborators: name: Liverpool John Moores University
name: Breathworks CIC
name: Primary Care Body (Jersey, United Kingdom)
First posted: 2022-08-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: waiting list controlled - then waiting list randomly allocated to one or two possible treatments. Effectively, one Arm, then splitting into two ( 1 + 2)
Primary purpose: TREATMENT

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 people's 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
* If/how these link with practical skills and any emotional or improvements in the participants' quality of life, use of medication or GP visits.
* If/how 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 30,000 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 teacher's 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 Impact/Outcome Risk Management/Mitigating Factors:

      Practicing mindfulness meditation has been known to trigger distressing memories in patients with existing Trauma/PTSD

      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 Trauma/PTSD 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 119,000 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 (N.B. this is United Kingdom Jersey - not US) is estimated currently at 106,000, 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 Day's 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 6/8 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.

      N.B. This study's 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 24/05/2022, their meeting on 26/05/2022 and formal email of approval on 30/05/2022.

Eligibility criteria: Once potential participants have consented, searches will be run on GP electronic health records to identify suitability. Demographic data including gender, age, ethnicity and employment status, pain diagnoses, current medication and dosage, co-morbidities and mental health diagnoses will be extracted via GP referral to the study, including that the patients meet inclusion criteria and do not meet any of the exclusions.

INCLUSION CRITERIA

* Diagnosis of Chronic Pain: Pain for longer than 3 months
* Ability to communicate and literacy in English
* Age 18 years or older
* No current outstanding medical tests or procedures for conditions expected by the GP to interfere with participation in treatment.
* Has not previously received non-medical treatment at a specialist pain centre, or attended a multidisciplinary pain management programme.
* Ability to utilise online video conferencing technology (i.e. ownership of a compatible device \& necessary technical competence)

EXCLUSION CRITERIA

* Patients who are actively suicidal
* terminally ill or have
* Dementia
* cognitive impairment
* learning difficulties, or
* the primary care physician knows of another reason to exclude.

Primary outcomes:
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 1: Acceptance utilising The 7-item Acceptance and Action Questionnaire v.2
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 1a: Pain Acceptance utilisikng the 8-item Chronic Pain Acceptance Questionnaire
timeFrame: baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 2: Contact with the Present Moment: The Mindful Attention Awareness Scale will be utilised.
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 3: Self in context: The Self Experience Questionnaire will be utlised.
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 4: Cognitive fusion: the Cognitive Fusion Questionnaire
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 5: Values: The Chronic Pain Values Inventory
timeFrame: baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention
measure: Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 6: Committed Action: The 8-item Committed Action Questionnaire
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
Secondary outcomes:
measure: IMMPACT consistent, changes in Pain Intensity (How sore the participant is) will be evaluated utilising the Brief Pain Inventory - Short Form (BPI)
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent, changes in Pain Interference (on functioning and aspects of quality of life) will be evaluated utilising the Brief Pain Inventory - Short Form (BPI)
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent measurement of change in emotional functioning: depression screening utilizing the Beck Depression Inventory - Fast Screen (BDI-FS)
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent measurement of change in emotional functioning: catastrophizing, utilizing Pain Catastrophizing Scale (PCS)
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent measurement of change in patient's ratings of global functioning
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent measurement of change in participants' disposition via subjective impression of change on pain, interference from pain, resilience on a scale of -100% (worse) to + 100% better.
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: IMMPACT consistent measurement of change in pain medication changes utilizing name and amount (mg/g) of pain / mood medication
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
measure: Accident and Emergency (A&E) and primary care GP visits
timeFrame: baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention
Other outcomes:
Locations:
city: St Helier
country: Jersey
facility: Pain Clinic
Study officials:
affiliation: Government of Jersey
name: Alessio Agostinis
role: PRINCIPAL_INVESTIGATOR
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