The Effectiveness of Exercise Combined With Acceptance and Commitment Therapy for Chronic Pain

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of a combined Exercise and Acceptance and Commitment Therapy (ACT) programme, compared to a standalone supervised exercise intervention for patients with chronic pain. Chronic pain is a common problem, which can have a significant impact on quality of life. While there are many treatments available for chronic pain, research has shown that improvements are often modest and short-term. Exercise therapy is known to be helpful for many chronic conditions and is recommended in clinical guidelines for the management of chronic pain. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy, which focuses on improvement of function, rather than symptom reduction. There is an emphasis on psychological flexibility, values and mindfulness. This approach may be well suited to chronic pain, where symptoms can be beyond a person's control, but there is a need for further research, particularly with regards to combining ACT with a physical intervention. This study will take place in a Dublin University hospital. Patients will be randomly allocated to a combined exercise and ACT treatment group or a standalone exercise group. Both groups will have weekly treatment for eight weeks and will be assessed before and after treatment, and again twelve weeks later. Questionnaires will be used to measure the effects of the treatment on the degree to which pain interferes with various aspects of daily life. Activity trackers will be worn to measure daily physical activity levels. A purposeful sample of participants from both groups will also be invited to participate in a qualitative study following treatment.

Detailed Description
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This prospective, two-armed, parallel group, single-centre Randomised Controlled Trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to a standalone supervised exercise intervention for chronic pain. One hundred and sixty patients aged 18 years and over, who have been diagnosed with a chronic pain condition by a medical doctor will be recruited to the trial. Participants will be individually randomised to one of two group interventions. The combined group will take part in eight, weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will also attend eight, weekly supervised exercise classes but will not take part in ACT programme. All participants will be assessed at baseline, immediately post intervention and at twelve-week follow-up. The primary outcome will be pain interference at twelve-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, pain related self-efficacy, quality of life, kinesiophobia, pain catastrophizing, pain acceptance, committed action, patient global impression of change, patient satisfaction with treatment, depression and anxiety. The number of investigations and pain related visits to healthcare professionals in the preceding three months will be recorded at baseline and twelve-week follow-up. Physical activity levels (average daily step count, distance travelled and active minutes) will be measured for all participants using Fitbit Zip activity trackers for one week prior to starting treatment and for the duration of the eight week intervention period. Participants will be invited to wear the activity trackers for one further week at the twelve-week follow-up time point. Estimates of treatment effects at follow up time-points will be based on an intention-to-treat framework, implemented using a linear mixed effects model. A purposeful sample of participants will be invited to attend individual interviews and focus groups, twelve weeks following completion of the interventions. Semi-structured interviews will be conducted, with the aim of exploring the views of participants of both interventions in order to enhance understanding of how these types of interventions work.

Official Title
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The ExACT Trial: The Effectiveness of Exercise Combined With Acceptance and Commitment Therapy Compared to a Standalone Supervised Exercise Intervention for Chronic Pain. A Randomised Controlled Trial

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Supervised Exercise
* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 years and over who have been diagnosed with chronic pain by a medical doctor Presence of persistent pain of greater than 12 weeks Ability to provide informed consent Ability to communicate adequately in spoken and written english Score of ≥ 3 on pain interference subscale of the Brief Pain Inventory Exclusion Criteria: Need for further diagnostic evaluation Presence of major medical or psychiatric disorder which would impede ability to participate with treatment Presence of active cancer or cancer related pain Unstable inflammatory condition e.g. rheumatoid arthritis or gout Surgical or pain interventional procedure (e.g. spinal cord stimulator, rhizotomy, intra-articular or epidural injection) during the last 3 months. Concurrent participation, or participation in the previous 3 months with any form of psychological therapy, physiotherapy or supervised exercise intervention Previous participation in any form of multidisciplinary pain management programme Presence of substance misuse Presence of any contraindication to participation in a gym or pool based exercise programme such as shortness of breath at rest, unstable diabetes or epilepsy, recent myocardial infarction, stroke, pulmonary embolism, asthma attack Weight > 125 kg or waist circumference > 50 inches (restriction die to pool evacuation equipment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Exercise and ACT treatment<br>Participants will attend a weekly group-based multidisciplinary pain programme for a period of eight weeks. The programme will combine exercise with the psychological approach acceptance and commitment therapy (ACT). | Behavioral: Supervised Exercise<br>* Participants will attend the weekly supervised exercise sessions for a period of eight weeks. The classes will be delivered to groups of up to ten participants and will be led by a physiotherapist. The classes will be one hour and thirty minutes in duration and will feature two components: education/advice and exercise. The education/advice sessions will cover topics such as pacing and goal setting and the physiotherapist will answer any queries from the participants in relation to physical activity over the course of the eight weeks. The exercise component will involve the provision of individualised exercises based on each participant's personal goals and the sessions will feature a combination of aerobic, stretching and strengthening exercise in a pool and a gym setting.<br>Behavioral: Acceptance and Commitment Therapy<br>* Participants will attend weekly group psychology sessions for an eight-week period. Each session will be two hours in duration and will delivered by a Senior Psychologist trained in Acceptance and Commitment Therapy (ACT). The sessions will feature an ACT treatment process that is designed to promote psychological flexibility through various methods including acceptance and values awareness. The overall aim is to promote behaviour change, enhancing patient engagement in meaningful activities and reducing pain-avoidant behaviours. There is an emphasis on mindfulness, experiential learning and the use of metaphor which is unique to ACT.<br>|
| Active Comparator: Standalone supervised exercise<br>Participants will attend a weekly group-based supervised exercise class for a period of eight weeks. | Behavioral: Supervised Exercise<br>* Participants will attend the weekly supervised exercise sessions for a period of eight weeks. The classes will be delivered to groups of up to ten participants and will be led by a physiotherapist. The classes will be one hour and thirty minutes in duration and will feature two components: education/advice and exercise. The education/advice sessions will cover topics such as pacing and goal setting and the physiotherapist will answer any queries from the participants in relation to physical activity over the course of the eight weeks. The exercise component will involve the provision of individualised exercises based on each participant's personal goals and the sessions will feature a combination of aerobic, stretching and strengthening exercise in a pool and a gym setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference measured with the Brief Pain Inventory - Interference scale | The interference subscale of the Brief Pain Inventory is a seven item self-report questionnaire that measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relations with people, enjoyment of life and sleep. | 12 week follow up (20 weeks from baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference measured with the Brief Pain Inventory Interference Scale | The interference subscale of the Brief Pain Inventory is a seven item self-report questionnaire that measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relations with people, enjoyment of life and sleep. | immediately post intervention (8 weeks from baseline) | 
| Change in pain severity measured with the Brief Pain Inventory (BPI) Composite pain score | Pain Severity will be measured using the composite pain score of the BPI | immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in pain self efficacy measured with the Pain Self Efficacy Questionnaire (PSEQ) | The PSEQ is a ten item questionnaire which assesses an individual's confidence in their ability to perform a variety of activities or tasks despite pain. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in quality of life measured with the EQ-5D-5L | The EQ-5D-5L assesses quality of life in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in fear of movement measured with the Tampa Scale for Kinesiophobia (TSK) | Fear of movement or re-injury has been reported to be a strong predictor of physical functioning and disability in chronic pain. The TSK is reported to be reliable and valid measure of fear of movement in individuals with chronic pain. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in pain catastrophising measured with the Pain Catastrophising Scale (PCS) | The PCS is a 13-item instrument designed to assess catastrophic thinking in relation to pain. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in pain acceptance measured with the Chronic Pain Acceptance Questionnaire (CPAQ - 8) | Pain acceptance is considered to be a treatment process variable and is regularly used in studies which feature ACT. The CPAQ-8 is a shortened version of the original 20-item CPAQ with two subscales; activity engagement and pain willingness. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in committed action measured with the Committed Action Questionnaire (CAQ-8) | Committed action is another treatment process variable which we propose to measure. The CAQ-8 is a shortened version of the original 18-item Committed Action Questionnaire which measures committed action in relation to commitment to valued goals. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Patient Global Impression of Change Scale (PGIC) | The PGIC scale measures a patient's rating of overall improvement or lack thereof due to the intervention. | Immediately post intervention (8 weeks from baseline) | 
| Patient satisfaction with treatment measured with a single question from the Client Satisfaction Questionnaire-8 | Satisfaction with treatment will be measured using a single question from the Client Satisfaction questionnaire (CSQ-8) which is designed to measure satisfaction with services. The question will ask In an overall, general sense, how satisfied are you with the service you have received? and four potential responses will be provided (very satisfied, mostly satisfied, indifferent or mildly dissatisfied and quite dissatisfied). The percentages of participants endorsing each of the responses will be reported. | Immediately post intervention (8 weeks from baseline) | 
| Change in symptoms of depression measured using the Patient Health Questionnaire-9 (PHQ-9) | Symptoms of depression will be assessed using the PHQ-9, which is a nine-item questionnaire generating scores ranging from 0 - 27. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in symptoms of anxiety measured with the General Anxiety Disorder-7 questionnaire (GAD-7) | The GAD-7 assesses symptoms of anxiety experienced during the last two weeks. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in self-reported healthcare utilisation | This questionnaire will collect data related to healthcare utilisation during the preceding three month period including GP visits, hospital consultant visits, visits to alternative health care practitioners, emergency department visits and number of nights of hospital in-patient stay. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 
| Change in physical activity levels (average weekly step count, distance travelled and active minutes) | Average weekly step count, distance travelled and active minutes will be measured using a FitBit Zip activity tracker for one week prior to randomisation and for the duration of the eight week intervention. | Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy, Exercise, Psychology, Psychological therapy, Physiotherapy, Physical therapy