Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in psychological flexibility assessed by the Acceptance and Action Questionnaire II over time
研究概览
简要总结
Twenty percent of US adults report chronic pain symptoms. Both psychological symptoms and sleep issues commonly co-occur with chronic pain. Chronic pain is a frequently reported symptoms of Chiari Malformation (CM); however, the cause of pain symptoms is not fully understood, and pain is not associated with the extent of neural abnormality in CM.
ACT is not a set of techniques, but rather a way of thinking. ACT encourages acceptance, as opposed to avoidance of unwanted feelings, all in the context of mindfulness (i.e., being aware of one's present environment and in tune with internal thoughts and emotions). ACT has been found to be successful at reducing pain perceptions and targeting multiple symptoms at one time. However, ACT has not been examined in CM and it is unknown whether ACT will improve sleep as well as pain-related symptoms. The purpose of the current study is to assess the efficacy of an online ACT intervention at reducing pain interference and sleep dysfunction symptoms in a sample with CM. It is hypothesized that CM patients may benefit from Acceptance and Commitment Therapy (ACT). More specifically it is hypothesized that the treatment group will report significantly less pain interference and psychological flexibility compared to the control group. It is also hypothesize that ACT will mediate the relationship between sleep dysfunction and pain interference.
Based on power analyses the sample size will be 56. The sample will be recruited online and randomized to the treatment or control group. The intervention will consist of eight modules that are administered weekly over eight weeks. Additionally, a 7-day sleep diary will be administered the week prior to the intervention and the week after the intervention. Follow up assessments will be administered upon completion of the 8-week intervention (at the beginning of week 9), 1-month after, and 3 months after the completion of the intervention.
详细描述
Chronic pain is extremely prevalent with 20% of adults in the US reporting symptoms (Dahlhamer, 2018). Further, when accounting for lost productivity and direct health care costs, the financial burden of chronic pain has been estimated to be $560-$630 billion annually (Gaskin & Richard, 2011). A myriad of factors contribute to chronic pain including psychological symptoms and sleep. Though psychological symptoms often co-occur with chronic pain with rates estimated to be as high as 50% (Kroenke et al., 2011), chronic pain co-occurs at an even higher rate with sleep dysfunction (89%) (van Hecke, Torrance, & Smith, 2013). Sleep is believed to have a reciprocal relationship with pain, such that pain impacts sleep and sleep impacts future pain (M. T. Smith, Huang, & Manber, 2005) reciprocal relationship makes sleep an essential aspect of chronic pain that warrants attention in interventions. One intervention that has shown particular promise in treating chronic pain is Acceptance and Commitment Therapy (ACT).
ACT is not a set of techniques, but rather an orientation. This orientation focuses on living a fulfilling life by way of living in line with one's values. In addition to living a life based on values, ACT encourages acceptance, as opposed to avoidance of unwanted feelings, all in the context of mindfulness (i.e., being aware of one's present environment and in tune with internal thoughts and emotions) (S. C. Hayes, Luoma, Bond, Masuda, & Lillis, 2006). Since the focus is on an orientation rather than specific techniques, ACT can be used as a transdiagnostic intervention, targeting multiple symptoms at one time. As previously noted, chronic pain is a complex diagnosis, with many interacting factors including psychological symptoms, sleep, and decreased daily functioning. ACT effectively treats the complex presentation of chronic pain. Chronic pain already costs society billions of dollars annually and administering psychological interventions are expensive and may not be available to all those in need. Online ACT interventions remedy this issue by providing services to those where treatment may not be readily available for a fraction of the price.
Though a handful of studies have explored different online ACT interventions, and found them to be efficacious, however, they have been unable to flexibly address individual differences in symptom presentations as they present the same information regardless of the participant's symptoms (Buhrman et al., 2013; S. Hayes et al., 2014; Kristjánsdóttir et al., 2013; Lin, Klatt, McCracken, & Baumeister, 2018; Simister et al., 2018; Trompetter, Bohlmeijer, Veehof, & Schreurs, 2015). Additionally, all prior online ACT interventions for chronic pain focused on pain primarily, providing examples and metaphors around the experience of pain. The aim is to administer an intervention that broadly teaches ACT philosophies without focusing only on pain, addressing individual differences in symptom presentation and allowing for personalization. The goal is to address chronic pain but to also facilitate the generalization of skills to comorbid conditions that often perpetuate the experience of chronic pain (i.e., depression, anxiety, and sleep dysfunction). Efficacy will be assessed through reductions in pain interference as well as comorbid conditions (i.e., sleep dysfunction, anxiety and depression).
Chronic pain is a commonly reported symptom of Chiari Malformation (CM). This under-researched diagnosis is characterized by the cerebellar tonsils descending 5mm or more into the spinal canal and impacts approximately 3.25 million people or 1% of the US population (B. W. Smith et al., 2013). Although chronic pain is commonly reported in CM, the etiology of a symptomatic presentation is not fully understood, and there is no direct relationship between the extent of descension of the cerebellar tonsils and pain. Regardless of elucidating the etiology of pain in CM, those with this complex chronic pain diagnosis would likely benefit from psychological and behavioral based interventions. Further, no ACT based intervention has been administered to a sample with Chiari Malformation. The purpose of the current study is to assess the efficacy of an online broad ACT intervention on a sample with Chiari Malformation.
Aim 1: Determine the efficacy and breadth of an online ACT intervention in decreasing pain interference, sleep dysfunction, depression, and anxiety.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •Chiari Malformation
- •Access to the internet
- •Be willing to commit approximately an hour a week for 8 weeks to engage in the intervention and homework
- •Experience persistent pain for a minimum of 3-months
- •Rate their pain intensity as greater than a 3 on a scale from 1-10
- •Be stable on psychotropic medication for the past 3 months (if taking psychotropic medication)
排除标准
- •Blindness
- •Currently receiving Acceptance or Commitment Therapy or Cognitive Behavioral Therapy
- •Have active suicidal ideations
- •Diagnosed with a severe psychiatric disorder including bipolar disorder and schizophrenia
结局指标
主要结局
Change in psychological flexibility assessed by the Acceptance and Action Questionnaire II over time
时间窗: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention
This 7-item inventory is measured on a Likert scale (1 = never true, 7 = always true) and is the most commonly utilized measure of experiential avoidance and psychological flexibility. There is no specified time domain that this questionnaire evaluates. This measure assesses negative evaluations of emotions, avoidance of difficult thoughts and emotions, and behavioral modifications while in the context of challenging thoughts or feelings and has demonstrated good validity, and test re-test reliability
Change in sleep dysfunction assessed by the Insomnia Severity Index over time
时间窗: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention
This 7-item index is used to capture perception of nocturnal and diurnal symptoms of insomnia over the past week. It specifically examines difficulties initiating sleep, maintaining sleep, and waking up too early, as well as satisfaction with current sleep, the perceived impact poor sleep has on quality of life and daily functioning, and distress related with sleep difficulties.
Change in sleep dysfunction assessed by the Daily Sleep Diary over time
时间窗: Assessed for 7 days prior to the intervention and for 7 days following the intervention.
This 12-question daily sleep diary assesses sleep duration, efficiency, and quality over the past night, these questions were used in a previous study (Tang, Goodchild, Sanborn, Howard, \& Salkovskis, 2012). Questions include bedtime, rise time, how long it took to fall asleep, number of wake times (disrupted sleep maintenance), and length of time asleep. Additionally, a rating of quality of sleep (0 = very poor, 10 = very good), cognitive arousal (i.e., racing thoughts prior to bed), somatic arousal (i.e., feeling restless or jittery prior to bed), level of current pain (0 = no pain at all, 10 = a lot of pain), predicted amount of pain over the next day (0 = no pain at all, 10 = a lot of pain), and mood (0 = very bad mood, 10 = very good mood) is assessed.
Change in depression and anxiety assessed by the Depression Anxiety and Stress Scale-21 over time
时间窗: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention
This 21-item measure that assesses depression, anxiety, and stress levels over the past week (Lovibond, Lovibond, \& Australia, 1995). Internal consistencies for depression, anxiety, and stress in prior research has been good (Taylor, Lovibond, Nicholas, Cayley, \& Wilson, 2005). In chronic pain samples the scale has demonstrated good internal consistency at the group level (Parkitny et al., 2012). Additionally, this measure does not include somatic symptoms in the depression scale, which prevents the depression score from being artificially inflated based on pain symptoms.
Change in pain interference assessed by the Brief Pain Inventory Short-form over time
时间窗: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention
This 9-item inventory assesses pain severity and pain interference over the past 24 hours. "Worst," "least," "average," and "current" pain severity are assessed. Pain interference items are measured on a scale from 0 - 10 (0 = Does not interfere, 10 = Completely interferes) and assesses the degree of pain interference in seven daily activities including general activity, walking, work, mood, enjoyment of life, relationships with others, and sleep. Prior research has demonstrated good internal validity and reliability in chronic pain samples.
次要结局
未报告次要终点
研究者
Douglas L. Delahanty
Professor and Associate Vice President of Research
Kent State University
