跳至主要内容
临床试验/NCT03207828
NCT03207828Unknown不适用

"Eficacia de la Terapia de activación Conductual Para Pacientes Con Dolor crónico: Ensayo clínico Randomizado"

Pontificia Universidad Catolica de Chile2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Changes in depressive symptoms severity

研究概览

简要总结

Chronic pain is a major health problem. It causes high economic and social costs around the world and severely impairs the quality of life of those who suffer from it. Chronic pain and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients. This intervention targets mechanisms of action that seem to be common to both disorders. In spite of this, the efficacy of this intervention has not been yet examined in people with both conditions. Therefore, the purpose of the present study is to examine the efficacy of BA compared to usual care among Chilean women with fibromyalgia and mayor depression (N = 90). Women will be randomized to an experimental arm (n = 45) who will receive usual care (UC) for fibromyalgia with comorbid depression plus BA; and a comparison arm, who will receive only UC for fibromyalgia with comorbid depression (n =45). Primary and secondary outcomes will be assessed before, during, and after the intervention, as well as at a three month follow-up. The investigators expect to find that, after treatment, the group receiving BA will experience higher statistical and clinical significant reductions in depressive symptom severity (primary outcome), as well as in their levels of some pain-related variables (namely pain intensity, fibromyalgia impact, pain-related anxiety, catastrophism, and physical health symptoms severity). In addition, the percentage of women in remission from the diagnosis of depression (as well as the percentage of women responding to treatment) will be greater in the experimental arm than in the comparison arm. Also, the percentage of women who show a clinically significant reduction in pain intensity (decreases greater than two units in the pain intensity scale) will be greater in the experimental arm than in the comparison arm. Finally, the investigators hypothesize that the decrease observed in the pain-related variables will be mediated by the decrease observed in depressive symptoms severity. Regarding the outcomes assessed at a three months follow-up, the investigators expect to find that the differences found after treatment between the two arms will be maintained at follow-up. In order to test our hypothesis, Hierarchical Linear Models (HLM) and Cochran-Mantel-Haenszel tests will be performed. The results of these study might contribute to facilitate the integrated treatment of fibromyalgia and depression, and to reduce the burden on the health system due to the lack of effective therapeutic strategies to treat these comorbidity.

详细描述

Chronic pain is a word-wide major health problem, which seriously affects the quality of life of those who experience it and causes important socio-economical costs (Tsang et al., 2008). According to the results of the last Chilean National Health Survey (2010), 34.2% of Chileans older than 15 years present pain ranging from moderate to severe. The pain experienced by a considerable proportion of these individuals (73.5%) is chronic. Among Chileans, chronic pain has been found to be related to more sickness leaves, a five-time increase in the use of primary care services, and the presence of depressive disorders (Miranda et al., 2013). In fact, around 35% patients with chronic pain suffer from depression (Gracely, Ceko, & Bushnell, 2012). In the case of some specific pain disorders such as fibromyalgia, this comorbidity is even greater (life prevalence around 90% for depressive symptomatology and 62-86% for major depressive disorder; Gracely et al., 2012). As a result, some authors posit that fibromyalgia and depression are two manifestations of a single affective spectrum disorder (Gracely et al., 2012). In fact, according to some evidence, both disorders share pathophysiological aspects. For example, pharmacological treatment of both fibromyalgia and depression includes the same dual serotonergic and noradrenergic agonists, namely, amitriptyline and duloxetine (Maletic & Raison, 2009).

Depressive symptoms impair chronic pain treatment and are associated with a worse chronic pain prognosis (Li, 2015). The increasing and concomitant prevalence of depression and chronic pain represents a burden for the primary care systems. Providing effective and appropriate primary care interventions to address this comorbidity is indeed needed, considering that chronic pain and depression lead to great disability. Taking into account that reducing disability is part of the second strategic objective of the Health Goals of the Decade 2011-2020 for Chile, the design and dissemination of therapeutic strategies aimed at the treatment of these problems is a priority in this country.

Behavioral Activation (BA) is an evidence-based psychological intervention for depression (Cuijpers, Van Straten, & Warmerdam, 2007; Dimidjian, Barrera, Martell, Muñoz, & Lewinsohn, 2011). It has been shown to be as effective as comprehensive cognitive behavioral therapy (Cuijpers et al., 2007) and antidepressant therapy (Dimidjian et al., 2006), with a lower dropout rate than the latter (Dimidjian et al., 2006). There is also evidence that BA works as well as medication and better than cognitive behavioral therapy in the treatment of severe depression (Dimidjian et al., 2006). Moreover, several meta-analyses support the efficacy of BA for the treatment of depression (Cuijpers et al., 2007; Ekers, Webster, Van Straten, Cuijpers, Richards, & Gilbody, 2014; Mazzucchelli, Kane, & Rees, 2009). According to the result of the last meta-analysis conducted (Ekers et al., 2014) - in which 26 randomized controlled trials (RCTs) were analyzed with a total of 1,524 participants - the treatment with BA is superior to the control condition (usual treatment, placebo, or waiting list), showing a high effect size (standardized mean difference, SMD: -0.74, 95% CI -0.91 a - 0.56). In addition, the examination of four RCTs with 283 participants showed that CT is also superior to medication. In this case the effect size was moderate (SMD -0.42, IC -0.83 to -0.00). Finally, according to the results of different studies conducted with several populations, BA can be used in multiple contexts and populations (Dimidjian et al., 2011) such as adolescents (Jacob, Keeley, Ritschel, and Craighead, 2013), seniors (Quijano et al., 2007), university students (Gawrysiak, Nicholas, & Hopko, 2009), and primary care patients (Uebelacker, Weisberg, Haggarty, & Miller, 2009).

More research on the efficacy of BA is still needed, especially with regard to its effect after follow-up; however the results reported so far are promising. Furthermore, BA is much easier to apply and disseminate than other psychological treatments. For these reasons, there is now an increasing interest in examining the efficacy of this intervention in populations with different comorbidities such as obesity, cancer, anxiety, borderline personality, substance abuse, childhood abuse history, smoking, and post-traumatic stress disorder, among others (Dimidjian et al., 2011).

BA could be particularly suitable for treating depression among patients with chronic pain, as some of its main purposes are fighting inactivity, increasing environmental reinforces, and decreasing aversive experiences. Indeed, inactivity, loss of reinforces, and excessive unpleasant experiences seem to play a key role in the etiology of both depressive disorders and chronic pain (Dimidjian et al., 2011, Leeuw et al. 2007). According to Lewinsohn's integrative model of depression (Lewinsohn, Hoberman, Teri, & Hautzinger, 1985), when a person with certain vulnerabilities faces a stressful event, that event and the emotions associated with it interrupt their normal behavior patterns, reduce the availability of the reinforcers in the environment, and increase the rate of aversive experiences. All this finally leads to depression. Depressive symptoms have a series of behavioral, cognitive, and emotional correlates that make the subject more vulnerable to new stressful events, thus creating a pathological cycle that is self-perpetuating in time. Something similar occurs when a person suffers a painful injury. According to Vlayen and Linton's Fear and Avoidance Model (FAM, 2000), in the face of a painful injury, vulnerable individuals (with increased pain catastrophizing or increased pain-related fear) develop strategies aimed at avoiding pain and the activities that cause it. This leads to inactivity, loss of reinforcers, disability, and depression, and consequently, to the exacerbation of the pain intensity and pain-related anxiety and catastrophizing. The patient is trapped in a vicious circle of symptoms that feed-back each other and perpetuate over time. Taking into account the FAM assumptions, as well as the purpose of the BA, this treatment may likely not only be useful for reducing depression in patients suffering from pain, but also for reducing the intensity of their pain and the anxiety and catastrophism associated with it. BA could break the chain of perpetuation in both disorders. In fact, there are preliminary data that support this premise. In a case study, in which BA was used with a woman who had been suffering from chronic pain associated with a diagnosis of fibromyalgia for 11 years, a clinically significant decrease in depressive symptoms was observed after treatment. In addition, the degree in which the pain interfered with the patient's daily activities was reduced (in a 100%), as well as pain-related anxiety and the use of pain medication use. These results (with the exception of reduction in medication use) were maintained within three months of the intervention (Lundervold, Talley, & Buermann, 2006). These same authors replicated these findings in another study, in which they applied the same treatment to another woman who had been suffering from fibromyalgia for 22 years. In this case, the decreases of pain intensity, pain-related anxiety, depression, and medication use were maintained three and six months after the intervention (Lundervold, Talley, & Buermann, 2008).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants: blind to hypothesis and blind regarding which conditions they have been assigned. To mask the condition, participants of both arms will receive the experimental intervention. Control participants will need to wait to receive the intervention. Control participants will know that the time waiting to be attended can vary among participants (and that even participants in the experimental group may have to wait). They also would know that (while waiting to be intervened) participants will need to attend to a series of assessments, and that five month is the longest period they will need to wait. Care providers: blind to all the study aspects but not to its aims. Investigators: blind to the subject treatment assignment and the outcomes. Outcomes assessors: blind to all aspects. Interventionist: blind to hypothesis and outcomes. Research assistant: blind to everything but not to aims and implementation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Behavioral activation group

Experimental

This group will receive usual care for fibromyalgia with comorbid major depression plus in-group behavioral activation.

干预措施: Usual care (Other)

Behavioral activation group

Experimental

This group will receive usual care for fibromyalgia with comorbid major depression plus in-group behavioral activation.

干预措施: Behavioral activation (Behavioral)

Usual care

Other

This group of participants will only receive usual care for fibromyalgia with comorbid depression.

Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) of the Red Salud Christus, the most important private medical care network in Chile. In this clinic treatment of fibromyalgia includes administering pregabalin and pain killers (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.

干预措施: Usual care (Other)

结局指标

主要结局

Changes in depressive symptoms severity

时间窗: Depressive symptoms will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. As such the participant will be assessed during five months.

Patients Health Questionnaire-9 (PHQ-9; Baader et al., 2008). It consists of 9 items evaluating the presence of depressive symptoms in the last two weeks. Its psychometric properties have been examined in Chilean population. It shows a sensitivity of 92% and specificity of 89%. Item response options are: 0 = never, 1 = some days, 2 = more than half the days and 3 = almost every day. Patients can be classified in: Major depressive syndrome: presence of 5 or more of the 9 depressive symptoms with an index of severity of more than half of the days, and one of the symptoms is mood depressive or anhedonia. Other depressive syndrome: presence of 2, 3 or 4 depressive symptoms for more of half the days and one of the symptoms is depressive mood or anhedonia. Positive depressive symptoms: presence of at least one or two of the symptoms depressive, but fails to complete the above criteria. Negative depressive symptoms: does not present any diagnostic criteria more than half of the days.

次要结局

  • Changes in environmental reward(The RPI will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up.)
  • Changes in self-reported physical health symptoms.(The PHQ-15 will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up.)
  • Changes in pain intensity(Pain intensity will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. As such the participant will be assessed during five months.)
  • Changes in physical functioning and fibromyalgia symptoms severity.(The FIQ-R will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up.)
  • Changes in pain catastrophizing(The PCS will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up.)
  • Changes in pain hypervigilance.(The PVAQ will be completed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lydia Gomez Perez

Principal Investigator

Pontificia Universidad Catolica de Chile

研究点 (2)

Loading locations...

相似试验