The Effectiveness of Exercise Combined With Acceptance and Commitment Therapy for Chronic Pain
NCT ID: NCT03050528
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2017-02-06
2018-12-30
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Combined Exercise and ACT treatment
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).
Supervised Exercise
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.
Acceptance and Commitment Therapy
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.
Standalone supervised exercise
Participants will attend a weekly group-based supervised exercise class for a period of eight weeks.
Supervised Exercise
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.
Interventions
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Supervised Exercise
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.
Acceptance and Commitment Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Mater Misericordiae University Hospital
OTHER
Health Research Board, Ireland
OTHER
King's College London
OTHER
University College Dublin
OTHER
Responsible Party
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Principal Investigators
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Maire-Brid Casey, BSc, MMT
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Locations
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Mater Misericordiae University Hospital
Dublin, , Ireland
Countries
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References
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Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
Raftery MN, Ryan P, Normand C, Murphy AW, de la Harpe D, McGuire BE. The economic cost of chronic noncancer pain in Ireland: results from the PRIME study, part 2. J Pain. 2012 Feb;13(2):139-45. doi: 10.1016/j.jpain.2011.10.004.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD007407. doi: 10.1002/14651858.CD007407.pub3.
Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-542. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19.
Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, Solomon BC, Lehman DH, Liu L, Lang AJ, Atkinson HJ. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011 Sep;152(9):2098-2107. doi: 10.1016/j.pain.2011.05.016. Epub 2011 Jun 17.
Casey MB, Smart KM, Segurado R, Hearty C, Gopal H, Lowry D, Flanagan D, McCracken L, Doody C. Exercise combined with Acceptance and Commitment Therapy compared with a standalone supervised exercise programme for adults with chronic pain: a randomised controlled trial. Pain. 2022 Jun 1;163(6):1158-1171. doi: 10.1097/j.pain.0000000000002487. Epub 2021 Sep 24.
Casey MB, Smart K, Segurado R, Hearty C, Gopal H, Lowry D, Flanagan D, McCracken L, Doody C. Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial. Trials. 2018 Mar 22;19(1):194. doi: 10.1186/s13063-018-2543-5.
Other Identifiers
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1/378/1864
Identifier Type: -
Identifier Source: org_study_id