Mindfulness Combined With Virtual Exercise Online (MOVE) Compared With a Self-Management Guide for Adults With Chronic Pain: Study Protocol for a Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of eligible participants recruited per programme
研究概览
简要总结
The aim of this study is to assess the feasibility and acceptability of a combined Mindfulness Based Stress Reduction (MBSR) and exercise online programme compared to an online self-management guide. Pain management programmes are the recommended treatment for chronic pain, however a number of barriers to their widespread implementation have been identified including geographical distance from speciality programmes, functional disability limiting the mobility of people with CP and economic limitations(1). eHealth interventions have the potential to address a number of these barriers and recent reviews have reported reductions in pain(2), improved knowledge and understanding about chronic pain and chronic pain management, improved function(3) and improvements in quality of life(4) following eHealth interventions.
The intervention in this study will be delivered online. Participants will be randomly allocated to a combined MBSR and exercise programme (Group A) or an online self-management guide (Group B). Group A will take part in an 8 week live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to a supervised exercise classes led by a Physiotherapist. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, which will be made available to participants biweekly.
Outcomes of feasibility and acceptability will be investigated in addition to a preliminary examination of between group clinical effects at baseline immediately post intervention and at a three month follow up, using validated patient reported outcome measures. In addition all participants will wear a Fitbit activity monitor for the duration of the eight-week interventions to capture activity measures. A qualitative study will also be conducted to gather participants' perceptions of the programme and its usefulness
详细描述
This study is a parallel-groups, randomised-controlled, feasibility trial. Seventy-five participants aged 18 years and over, who have been diagnosed with a chronic pain condition by a Consultant in Pain Medicine or a General Practitioner will be recruited to the feasibility study. Participants will be individually randomised to one of two interventions. Group A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to supervised exercise classes led by a Physiotherapist. The combined 3 hour intervention (2 hours MBSR, 1 hour exercise) will take place one day per week for 8 weeks. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, with the material released biweekly.
The key outcomes measures will include; (1) recruitment rates, eligibility rates, willingness to be randomised; (2) feasibility and acceptability of data collection instruments and procedures; (3) intervention adherence, engagement and attrition rates; (4) feasibility and acceptability of the interventions and; (5) participants' subjective perceptions of the programmes.
The study will also include a preliminary examination of between group clinical effects at baseline, immediately post intervention and at a three month follow up, using the following validated patient reported outcome measures; Pain Self-Efficacy Questionnaire, Brief Pain Inventory, Pain Catastrophizing Scale, Generalised Anxiety Depression Assessment, Patient Health Questionnaire-9, Pain Disability Index, Fear Avoidance Belief Questionnaire, Short-Form-36 Health Survey, Patient Global Impression of Change Scale and measure of treatment satisfaction adapted from the Client Satisfaction Questionnaire (CSQ-8).
Physical activity levels (average daily step count, distance travelled and active minutes) will be measured for all participants using Fitbit Charge 4 activity monitors for the duration of the eight-week intervention period.
Analyses of the feasibility study will primarily be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and the procedures of the study. Between-group comparisons of clinical treatment effects will be descriptive and exploratory to consider the viability of the combined MBSR and exercise intervention that may warrant further exploration in a fully powered RCT.
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
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of eligible participants recruited per programme
时间窗: Baseline
Prior to each programme the number of eligible participants who are recruited will be recorded by the primary researcher
Number of participants who complete the study
时间窗: immediately post intervention (8 weeks from baseline)
The number of participants that complete \>50% of the online classes programme
Number of eligible participants identified per programme
时间窗: Baseline
Prior to each programme the number of eligible participants will be recorded by the primary researcher
Adherence to completion of baseline patient reported outcome measures
时间窗: Baseline
Numbers of participants completing \> 90% of baseline patient reported outcome measures
Adherence to completion of immediate follow-up patient reported outcome measures
时间窗: Immediately post intervention (8 weeks from baseline)
Numbers of participants completing \> 90% of follow-up patient reported outcome measures
Adherence to completion of long term follow-up patient reported outcome measures
时间窗: 3 months post intervention (20 weeks from baseline)
Numbers of participants completing \> 90% of follow-up patient reported outcome measures
Reasons for non-participation
时间窗: Baseline
This measure will be recorded by the primary researcher when screening participants
Interaction with online self-management guide
时间窗: Immediately post intervention (8 weeks from baseline)
The study website analytics will measure the number of views that each element of the online guide receives (Group B)
Treatment Acceptability (Satisfaction assessed by Client Satisfaction Questionnaire-8)
时间窗: Immediately post intervention (8 weeks from baseline)
Patient satisfaction with treatment will be measured with an adapted version of the Client Satisfaction Questionnaire-8. Responses are scored from 1-4, and the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction.
Interface usability
时间窗: immediately post intervention (8 weeks from baseline)
Measures of website usability will be investigated with an adapted System Usability Scale (SUS) Scores range from 10-50. Higher scores indicated greater ease of usability.
次要结局
- Changes in symptoms of depression measured with the Patient Health Questionnaire 9(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Changes in step count (Fitbit)(immediately post intervention (8 weeks from baseline))
- Change in symptoms of anxiety measured with the Generalized Anxiety Disorder Assessment(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(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Change in quality of life measured with the Short Form-36 Health Survey(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Changes in distance travelled (Fitbit)(immediately post intervention (8 weeks from baseline))
- Changes in active minutes (Fitbit)(immediately post intervention (8 weeks from baseline))
- Changes in the impact of pain on individuals life participation measured with the Pain Disability Index(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Changes in fear avoidance of physical activity measured with the Fear Avoidance Belief Questionnaire.(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
- Patient Global Impression of Change Scale(immediately post intervention (8 weeks from baseline))
- Changes in pain severity and pain interference measured with the Brief Pain Inventory-Composite pain score(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.(immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline))
研究者
Orla Deegan
Prinicipal Investigator
University College Dublin