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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in pain interference measured with the Brief Pain Inventory - Interference scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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).
干预措施: Supervised Exercise (Behavioral)
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).
干预措施: Acceptance and Commitment Therapy (Behavioral)
Standalone supervised exercise
Participants will attend a weekly group-based supervised exercise class for a period of eight weeks.
干预措施: Supervised Exercise (Behavioral)
结局指标
主要结局
Change in pain interference measured with the Brief Pain Inventory - Interference scale
时间窗: 12 week follow up (20 weeks from baseline assessment)
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.
次要结局
- 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 acceptance measured with the Chronic Pain Acceptance Questionnaire (CPAQ - 8)(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)(Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Change in self-reported healthcare utilisation(Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Patient Global Impression of Change Scale (PGIC)(Immediately post intervention (8 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))
- Change in pain catastrophising measured with the Pain Catastrophising Scale (PCS)(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)(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(immediately post intervention (8 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))
- Patient satisfaction with treatment measured with a single question from the Client Satisfaction Questionnaire-8(Immediately post intervention (8 weeks from baseline))
- Change in physical activity levels (average weekly step count, distance travelled and active minutes)(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)(Immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))