Contribution of Online Stress and Pain Mindfulness Treatment to ACT Process Change and Outcomes in Chronic Pain

NCT05498454 | Unknown

• 1 other identifier: MT/LC 11/10/2019
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

mindfulness; chronic pain; pain; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (7)

• 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

  This will be utilised to measure and track the patient's change (if any) - at relevant time points in the study - in willingness to experience general unpleasant feelings and emotions that are not pain related (not to unfairly disadvantage the stress version of the course). Assessed by Likert scale on multiple itemts (1 = Never True ; 7 = Always true)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention

• 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

  This will be utilised to measure and track the patient's changes (if any) - at relevant at each time point in the study - with acceptance of pain. Assessed by Likert Scale on multiple items (0 = Never true; 6 = always true).

  baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention

• 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.

  This will be utilised to track and measure the patient's changes (if any) - at each time point in the study - of mindful attention and awareness. Assessed by Liker Scale on multiple items (1 = Almost Always; 6 = Almost Never)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention

• 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.

  This measure will be utilised to track and measure the changes (if any) - at each time point in the study - of patient's ability to observe themselves as separate from triggering processes. Assessed by Likert Scale on multiple items (0 = never true; 6 = always true)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention

• 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

  This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - with how entangled they are with thinking.Assessed by Likert Scale on multiple items (1 = Never True; 7 = always true)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention

• 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

  This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - with how able they are to notice what matters in their life and their discrepancy with / from it. Assessed via Likert scale on importance/success 0 - 5 (0 = not at all important/successful; 5 = extremely important/successful)

  baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention

• 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

  This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - their ability to commit to valuable behaviours. Assessed by likert scale on multiple items (0 = Never True; 6 = always true)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention

Secondary Outcomes (8)

• IMMPACT consistent, changes in Pain Intensity (How sore the participant is) will be evaluated utilising the Brief Pain Inventory - Short Form (BPI)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention

• 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)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention

• IMMPACT consistent measurement of change in emotional functioning: depression screening utilizing the Beck Depression Inventory - Fast Screen (BDI-FS)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention

• IMMPACT consistent measurement of change in emotional functioning: catastrophizing, utilizing Pain Catastrophizing Scale (PCS)

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention

• IMMPACT consistent measurement of change in patient's ratings of global functioning

  baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention

Study Arms (3)

Breathworks Mindfulness for Health

ACTIVE COMPARATOR

an 8-week, online, protocol based mindfulness course designed to manage chronic pain and chronic health conditions

Behavioral: Breathworks Mindfulness (Health or Stress Arm)

Breathworks Mindfulness for Stress

ACTIVE COMPARATOR

an 8-week, online, protocol based mindfulness course designed to manage stress

Behavioral: Breathworks Mindfulness (Health or Stress Arm)

Waiting list

NO INTERVENTION

The Waiting list will be for the whole sample of participants (acting as a waiting list control). From this, participants will be randomly allocated to one of the Arms above

Interventions

Breathworks Mindfulness (Health or Stress Arm) BEHAVIORAL

As for previous descriptions

Breathworks Mindfulness for Health; Breathworks Mindfulness for Stress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government of Jersey: lead
• Liverpool John Moores University: collaborator
• Breathworks CIC: collaborator
• Primary Care Body (Jersey, United Kingdom): collaborator

Study Sites (1)

Pain Clinic

Saint Helier, JE1 3UH, Jersey

Location

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MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Health

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Alessio Agostinis

  Government of Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analysis will be performed blind by one of the researchers - after data has been anonymised and transferred.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Psychologist

Model Details: waiting list controlled - then waiting list randomly allocated to one or two possible treatments. Effectively, one Arm, then splitting into two ( 1 + 2)

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 12, 2022
• Study Start: December 21, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

JE (1)