Integrated Care for Depression and Chronic Back Pain

描述(申请人提供)：研究目标：我们的长期目标是改善患有抑郁症和慢性疼痛的患者的功能、症状和护理费用。这项提案寻求对抑郁症和慢性背痛综合干预的试点研究的支持。拟议的试验性研究将实现以下具体目标： 目的1：为慢性腰背痛伴重度抑郁症患者制定综合干预方案。这项研究将为患有严重抑郁症的慢性背痛患者开发一种综合的生物心理社会干预措施。综合干预包括对严重抑郁症的有效干预(问题解决疗法和/或抗抑郁药物，取决于患者的偏好)和对慢性背痛的简短认知-行为干预，也被证明是有效的。 目的2：开发诱导和评估干预保真度的方法。我们将使用多种方法(提供者评级、患者评级、患者日志和录音带的独立评级)来评估综合干预措施的交付、接收和实施。我们将评估独立评分录音带的评价者之间的可靠性，从不同来源获得的保真度测量的收敛有效性，以及干预保真度不同组成部分之间的相关性。 目的3：对抑郁型慢性腰背痛患者进行综合干预的中试。我们将对50名干预患者和50名照常护理的患者进行综合干预的试点试验。试点随机对照试验将评估筛查完成率和合格率；随机分配到干预组的患者参与综合干预的情况；提供者交付的保真度和患者接受干预的情况；患者实施干预的程度，通过衡量患者对药物和行为治疗的依从性来评估；参与的初级保健医生对综合干预的接受程度；以及6个月后疼痛、抑郁和功能结果的干预效果大小。我们将评估抑郁症和慢性背痛的综合治疗相对于仅对背痛进行短暂的认知行为干预的增量效益(通过将干预患者与仅接受慢性背痛认知行为干预的历史对照组进行比较)。

DESCRIPTION (provided by applicant): Research Goal: Our long-term goal is to improve the functional, symptom and cost of care outcomes among patients with co-morbid depression and chronic pain. This proposal seeks support for a pilot study of an integrated intervention for depression and chronic back pain. The proposed pilot study will accomplish the following specific aims: Aim 1: Develop an integrated intervention for chronic back pain patients with major depression. This research will develop an integrated, biopsychosocial intervention for chronic back pain patients with major depression. The integrated intervention incorporates proven interventions for major depression (Problem-Solving Therapy and/or antidepressant medications depending on patient preferences) with brief cognitive-behavioral interventions for chronic back pain, also of proven effectiveness. Aim 2: Develop methods for inducing and assessing intervention fidelity. We will assess the delivery, receipt and enactment of the integrated intervention with multiple methods (provider ratings, patient ratings, patient logs, and independent ratings of audiotapes). We will assess the inter-rater reliability of independent ratings of audiotapes, the convergent validity of fidelity measures obtained from different sources, and the correlation of different components of intervention fidelity. Aim 3: Conduct a pilot test of the integrated intervention for depressed chronic back pain patients. We will conduct a pilot test of the integrated intervention with 50 intervention and 50 care as usual control patients. The pilot RCT will assess screening completion and eligibility rates; participation in the integrated intervention among patients randomly assigned to the intervention arm; the fidelity of provider delivery and patient receipt of the intervention; levels of patient enactment of the intervention as assessed by measures of patient adherence with pharmacologic and behavioral treatments; acceptability of the integrated intervention to participating primary care physicians; and intervention effect size at 6 months for pain, depression and functional outcomes. We will assess the incremental benefit of integrated management of depression and chronic back pain relative to brief cognitive-behavioral intervention for back pain alone (through comparison of intervention patients to historical controls receiving only a cognitive-behavioral intervention for chronic back pain).