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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03050528
• Date of registration: 06/02/2017
• Prospective Registration: Yes
• Primary sponsor: University College Dublin
• Public title: The Effectiveness of Exercise Combined With Acceptance and Commitment Therapy for Chronic Pain ExACT
• Scientific title: 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
• Date of first enrolment: February 6, 2017
• Target sample size: 175
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03050528
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Maire-Brid Casey, BSc, MMT
• Affiliation: University College Dublin

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pain

Intervention(s)

Behavioral: Supervised Exercise

Behavioral: Acceptance and Commitment Therapy

Primary Outcome(s)

Change in pain interference measured with the Brief Pain Inventory - Interference scale [Time Frame: 12 week follow up (20 weeks from baseline assessment)]

Secondary Outcome(s)

Change in committed action measured with the Committed Action Questionnaire (CAQ-8) [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Change in pain interference measured with the Brief Pain Inventory Interference Scale [Time Frame: immediately post intervention (8 weeks from baseline)]

Patient satisfaction with treatment measured with a single question from the Client Satisfaction Questionnaire-8 [Time Frame: Immediately post intervention (8 weeks from baseline)]

Change in symptoms of anxiety measured with the General Anxiety Disorder-7 questionnaire (GAD-7) [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Patient Global Impression of Change Scale (PGIC) [Time Frame: Immediately post intervention (8 weeks from baseline)]

Change in pain acceptance measured with the Chronic Pain Acceptance Questionnaire (CPAQ - 8) [Time Frame: 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 [Time Frame: 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) [Time Frame: 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) [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Change in symptoms of depression measured using the Patient Health Questionnaire-9 (PHQ-9) [Time Frame: 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) [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Change in pain severity measured with the Brief Pain Inventory (BPI) Composite pain score [Time Frame: 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) [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Change in self-reported healthcare utilisation [Time Frame: Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)]

Secondary ID(s)

1/378/1864

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Health Research Board, Ireland

King's College London

Mater Misericordiae University Hospital