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

Máire-Bríd Casey, Keith Smart, Ricardo Segurado, Conor Hearty, Hari Gopal, Damien Lowry, Dearbhail Flanagan, Lance McCracken, Catherine Doody, Máire-Bríd Casey, Keith Smart, Ricardo Segurado, Conor Hearty, Hari Gopal, Damien Lowry, Dearbhail Flanagan, Lance McCracken, Catherine Doody

Abstract

Background: Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise.

Methods/design: 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 supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit ZipTM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a purposeful sample of participants to explore patient experiences of both treatments.

Discussion: To our knowledge, this will be the first RCT to examine whether combining exercise with ACT produces greater benefit for patients with chronic pain, compared to a standalone supervised exercise programme.

Trial registration: www.ClinicalTrials.gov, ID: NCT03050528 . Registered on 13 February 2017.

Keywords: Acceptance and commitment therapy; Chronic pain; Exercise; Multidisciplinary pain programme; Physical therapy; Physiotherapy; Psychological therapy.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been granted from the Mater Misericordiae University Hospital Institutional Review Board and the University Hospital Dublin Human Research Ethics Committee. Written consent will be collected from all participants prior to enrolment.

Consent for publication

Patients will be informed, prior to consenting to participate in the trial, that the results of the study may be presented at academic conferences or published in peer-reviewed journals. Participants will be assured that their confidentiality will be maintained at all times and they will not be identifiable in any publications.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Diagram

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