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

NCT03050528 | Completed

• 1 other identifier: 1/378/1864
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Acceptance and Commitment Therapy; Exercise; Psychology; Psychological therapy; Physiotherapy; Physical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in pain interference measured with the Brief Pain Inventory Interference Scale

  immediately post intervention (8 weeks from baseline)

• Change in pain severity measured with the Brief Pain Inventory (BPI) Composite pain score

  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)

  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

  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)

  Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)

Study Arms (2)

Combined Exercise and ACT treatment

EXPERIMENTAL

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; Behavioral: Acceptance and Commitment Therapy

Standalone supervised exercise

ACTIVE COMPARATOR

Participants will attend a weekly group-based supervised exercise class for a period of eight weeks.

Behavioral: Supervised Exercise

Interventions

Supervised Exercise BEHAVIORAL

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.

Combined Exercise and ACT treatment; Standalone supervised exercise

Acceptance and Commitment Therapy BEHAVIORAL

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.

Combined Exercise and ACT treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Dublin: lead
• Mater Misericordiae University Hospital: collaborator
• Health Research Board, Ireland: collaborator
• King's College London: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Related Publications (7)

• 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.

  PMID: 16095934 BACKGROUND

• 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.

  PMID: 22300900 BACKGROUND

• 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.

  PMID: 23152245 BACKGROUND

• 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.

  PMID: 21251756 BACKGROUND

• 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.

  PMID: 21683527 BACKGROUND

• 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.

  PMID: 34913883 DERIVED

• 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.

  PMID: 29566744 DERIVED

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maire-Brid Casey, BSc, MMT

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The academic Statistician (Dr Ricardo Segurado) and the Senior Researcher (Maire-Brid Casey) will be blind to group allocation. Dr Segurado will be responsible for data analysis. Máire-Bríd Casey will be responsible for data entry and will assist with data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 13, 2017
• Study Start: February 6, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

IE (1)