Online Acceptance-based Behavioural Treatment for Fibromyalgia
2015年11月30日 更新者:Heather Simister、University of Manitoba
Online Acceptance-Based Behavioural Treatment for Fibromyalgia
A recent study published by the Canadian Pain Society estimated the direct health care costs of chronic pain to be about 6 billion dollars.
Over 1/3 of all Canadians reported that they either missed work or experienced reduced productivity due to chronic pain.
Fibromyalgia Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom are still in the prime of their lives.
While pain and fatigue are prominent symptoms, FMS sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache, memory and thinking problems, and depression.
Standard treatments focus on medication and physical exercise but are not always successful.
Acceptance-Based behavioural therapy (ABBT) is a relatively new approach that has been effective not only in treating mental health concerns such as anxiety and depression, but also other medical conditions such as diabetes and chronic pain.
A novel ABBT for FMS was developed and pilot tested with a small group of participants.
The results of this preliminary study were promising.
Unfortunately, many people cannot adequately access available treatment due to long wait lists, prohibitive costs, or time/location constraints.
Online treatments may offer improved access to care without reducing the effectiveness of treatment.
Therefore, the ABBT for FMS used in the pilot study is being adapted to an online format and will be evaluated with a larger group of participants.
A wait-list/control group will be employed to evaluate the effectiveness of the online treatment as compared with treatment-as-usual.
If found effective, this treatment would offer patients easier access to care at a significantly reduced cost to the health care system.
研究概览
详细说明
The current study extended a pilot study (Shay, Tkachuk, Simister, Bailly, & Skrabek, 2011), modifying the previous treatment to a 6 unit program that could be delivered online.
Sixty-one participants completed the study, being randomly assigned to an online ABBT plus treatment-as-usual (online ABBT + TAU) group or a treatment-as-usual alone (TAU) group.
All participants completed a series of self-report measures at baseline, at post-treatment, and at a 3-month follow-up.
Linear mixed modelling supported significant differences between the groups in favour of the ABBT + TAU treatment group on the primary outcome measure (Fibromyalgia Impact Questionnaire-Revised (FIQ-R); F (2, 52.82) = 20.10,
p < .0001)
following treatment.
The online ABBT + TAU group also had significantly greater improvements in depression, pain, acceptance, perceived helplessness, and kinesiophobia.
Increased acceptance mediated the effects of treatment on improvements in FMS quality of life and FMS impact, while reduced helplessness mediated the effects of treatment on improvements in level of reported pain.
Comments and subjective ratings of improvement were consistent with the quantitative results.
Participants rated mindfulness (contact with present moment experience) as the most useful treatment unit.
研究类型
介入性
注册 (实际的)
67
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Manitoba
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Winnipeg、Manitoba、加拿大、R3A 1R9
- Health Sciences Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants of either sex aged 18 years and older with a formal diagnosis of FMS will be recruited.
- Individuals younger than 18 years of age will be excluded in order to ensure all participants have reached the age of majority and can provide consent.
- They will have a pain intensity rating of at least 4/10 based on self-report. Participants will also be screened using the Wolfe et al (2010) criteria during the in-person session to ensure they meet criteria for FMS.
- Must reside in and complete study from within Manitoba, Canada
Exclusion Criteria:
- People with co-morbidities such as rheumatologic conditions, other conditions affecting the immune system (e.g. chronic fatigue syndrome, multiple sclerosis, lupus), brain injury, cognitive impairment that would limit a participant's ability to complete informed consent, active psychosis, substance abuse, uncontrolled major depression or bipolar disorder, active suicidality, or those who have current active injury claims will be excluded.
- Given the use of a large amount of reading materials, participants will be asked if they have completed at least grade 9 in high school. Those who have only completed grade 8 or lower will be excluded.
- Further, participants will be asked to maintain their pre-study treatment regime and not making changes to their medications or beginning other treatments for the duration of the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Treatment-as-usual
Participants continue their pre-study treatment plan, based on their physician/other professional recommendations
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Participants will continue pre-study treatment under their current licensed practitioners.
Intervention may include drug treatment, physical therapy, or other
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|
实验性的:Online ABBT treatment + TAU
Participants to complete a 6-unit online Acceptance-based behavioural treatment including training in pacing, mindfulness, acceptance, cognitive defusion, willingness, and exercise while also maintaining their pre-study treatment.
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Participants will continue pre-study treatment under their current licensed practitioners.
Intervention may include drug treatment, physical therapy, or other
Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Fibromyalgia Impact Questionnaire-revised
大体时间:baseline, 2 months, 5 months
|
Assesses overall impact of Fibromyalgia symptoms on daily functioning
|
baseline, 2 months, 5 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Center for Epidemiological Studies Depression Scale
大体时间:Baseline, 2 months, 5 months
|
Evaluation of depressive symptoms
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Chronic Pain Acceptance Questionnaire
大体时间:Baseline, 2 months, 5 months
|
Overall acceptance of chronic pain
|
Baseline, 2 months, 5 months
|
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Change from baseline in Cognitive Fusion Questionnaire
大体时间:Baseline, 2 months, 5 months
|
Evaluation of fusion with thoughts
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Baseline, 2 months, 5 months
|
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Change from baseline in McGill Pain Questionnaire- short form
大体时间:Baseline, 2 months, 5 months
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subjective measure of type and severity of pain
|
Baseline, 2 months, 5 months
|
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Change from baseline in Five Facet Mindfulness Questionnaire
大体时间:Baseline, 2 months, 5 months
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Measure of mindfulness skills
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Baseline, 2 months, 5 months
|
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Change from baseline in Pittsburgh Sleep Quality Index
大体时间:Baseline, 2 months, 5 months
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Measure of sleep quality and quantity
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Baseline, 2 months, 5 months
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Change from baseline in Tampa Scale of Kinesiophobia-11
大体时间:Baseline, 2 months, 5 months
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Measure of fear of movement
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Baseline, 2 months, 5 months
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Change from baseline in Valued Living Questionnaire
大体时间:Baseline, 2 months, 5 months
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Measure of values, and how consistently one lives those values
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Baseline, 2 months, 5 months
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Global Assessment Scale
大体时间:2 months
|
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
|
2 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Heather Simister, MA、University of Manitoba
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年9月1日
初级完成 (实际的)
2014年8月1日
研究完成 (实际的)
2015年8月1日
研究注册日期
首次提交
2012年6月25日
首先提交符合 QC 标准的
2012年7月15日
首次发布 (估计)
2012年7月17日
研究记录更新
最后更新发布 (估计)
2015年12月2日
上次提交的符合 QC 标准的更新
2015年11月30日
最后验证
2015年11月1日
更多信息
与本研究相关的术语
其他研究编号
- H2012:179
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.