Therapeutic IVR For Relapse Prevention in Chronic Pain

用于预防慢性疼痛复发的治疗性 IVR

• 批准号: 7663790
• 负责人: Magdalena R Naylor
• 金额: $ 31.04万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-12 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7663790
• 关键词: Absence of pain sensation; Accounting; Adverse effects; Aftercare; Alcohol or Other Drugs use; Analgesics; Attention; Award; Back Pain; Behavior Therapy; Behavioral; Cardiovascular Physiology; Chronic; Clinical Research; Clinical Trials Cooperative Group; Cognitive; Computers; Consent; Control Groups; Controlled Clinical Trials; Coping Skills; Data Analyses; Degenerative polyarthritis; Dependence; Doctor of Philosophy; Educational Intervention; Educational process of instructing; Epidemiology; Feedback; Funding; Goals; Grant; Group Therapy; Health Care Costs; Implantable Infusion Pumps; Individual; Intervention; Intervention Studies; Investigation; Low Back Pain; Maintenance; Medical; Medicare; Methods; Monitor; Musculoskeletal Diseases; Musculoskeletal Pain; Narcotic Analgesics; National Institute of Drug Abuse; Operative Surgical Procedures; Opioid; Outcome; Outcome Measure; Pain; Pain management; Patients; Persistent pain; Pilot Projects; Psychiatrist; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Research Design; Research Personnel; SF-36; Sampling; Self Efficacy; Self Management; Spinal Cord; Spinal Fusion; Substance Use Disorder; Symptoms; System; Technology; Telephone; Testing; Therapeutic; Therapeutic Uses; Touch sensation; Training; Treatment Efficacy; United States National Institutes of Health; Upper Extremity; Upper arm; Vertebral column; Voice; Work; base; career; chronic pain; cognitive behavior therapy; comparative efficacy; comparison group; coping; cost effective; disability; disorder later incidence prevention; economic impact; effective therapy; efficacy testing; experience; follow-up; improved; middle age; non-cancer pain; novel; prescription drug abuse; prevent; proband; programs; psychologic; psychological distress; rehearsal; response; skills training; social; standard care; tool; treatment strategy

DESCRIPTION (provided by applicant): We propose to explore a well-known telephone-based technology (IVR) as a tool to reduce the pain, physical disability, and psychological distress experienced by patients with chronic musciiloskeletal pain. IVR (Interactive Voice Response) is a computer-based, automated telephone system that enables callers to respond to a recorded voice via the telephone keypad. Using this technology, we developed Therapeutic IVR (TIVR) as a tool for maintenance enhancement fallowing group cognitive-behavioral coping skills training (CST), a widely used behavioral treatment for chronic pain. The TFVR has four components: 1) an automated daily questionnaire for self monitoring, 2) a didactic review of coping skills, 3) guided behavioral rehearsals of CST coping skills, and 4) monthly feedback messages recorded on to the TIVR by the therapist. All four components can be accessed remotely by patients via any touch-tone phone. We initially tested the feasibility of the TIVR in a convenience pilot sample of 18 subjects. Ten patients with severe, chronic musculoskeletal pain participated in 11 weeks of group CST followed by four months of TIVR. A comparison sample of eight subjects received the same group CST by the same therapist, but not the TIVR. Both groups showed improvement after CST. However, between subjects analysis across the two groups showed that relevant outcome scores in the comparison sample worsened in the four months after CST whereas the same outcomes in the TIVR group improved during this period. In a second (ongoing) pilot study funded by a NIDA R21 grant, we are attempting to determine if the TIVR can be used to improve coping, decrease pain and reduce pain medication use. Study design and outcome measures are similar to those of the initial pilot study except that subjects are randomized. We have now analyzed data from 34 subjects, 15 probands and 19 controls. Preliminary results on the efficacy of the TIVR confirm the results of the initial pilot study. Between subjects analysis (ANCOVA) revealed statistically significant inter-group differences in: TOPS Pain Symptoms, TOPS Total Pain Experience, SF-36 Physical Composite, and CSQ Ability to Control Pain at both 4 and 8 months follow-up. The present R01 application is for a randomized controlled trial (RCT) of the TIVR in 150 patients with chronic musculoskeletal pain. We propose a 3-arm study. As before, all subjects will be given our standard 11 weeks of CST for pain coping skills. Consenting subjects will then be randomly assigned to one of three study conditions: 1) a no TIVR control condition (standard treatment); 2) an attention control condition, four months of calls to the Daily Self-monitoring Questionnaire with minimum monthly feedback; or 3) the full TIVR condition, four months of calls to the Full TIVR (all four components). The study goals are: 1) to attempt to replicate the results of the two pilot studies of TIVR in a full-scale RCT; and 2) to determine the efficacy of the full TIVR in relation to an attention control condition.

描述（由申请人提供）：我们建议探索一种众所周知的基于电话的技术（IVR）作为减少慢性肌肉骨骼疼痛患者所经历的疼痛、身体残疾和心理困扰的工具。 IVR（交互式语音响应）是一种基于计算机的自动电话系统，使呼叫者能够通过电话键盘对录制的语音做出响应。利用这项技术，我们开发了治疗性 IVR (TIVR)，作为维护增强休闲群体认知行为应对技能训练 (CST) 的工具，这是一种广泛用于慢性疼痛的行为治疗方法。 TFVR 有四个组成部分：1）用于自我监控的自动每日调查问卷，2）应对技能的教学审查，3）CST 应对技能的引导行为演练，以及 4）治疗师每月记录在 TIVR 上的反馈信息。患者可以通过任何按键式电话远程访问所有四个组件。 我们最初在 18 名受试者的便利试点样本中测试了 TIVR 的可行性。 10 名患有严重慢性肌肉骨骼疼痛的患者参加了为期 11 周的 CST 组，随后进行了 4 个月的 TIVR。八名受试者的比较样本接受了同一治疗师的同一组 CST，但没有接受 TIVR。 CST 后两组均表现出改善。然而，两组受试者之间的分析显示，比较样本中的相关结果评分在 CST 后四个月内恶化，而 TIVR 组的相同结果在此期间有所改善。在由 NIDA R21 拨款资助的第二项（正在进行的）试点研究中，我们试图确定 TIVR 是否可用于改善应对、减轻疼痛和减少止痛药的使用。研究设计和结果测量与最初的试点研究相似，只是受试者是随机的。我们现在已经分析了 34 名受试者、15 名先证者和 19 名对照者的数据。 TIVR 功效的初步结果证实了初步试点研究的结果。受试者间分析 (ANCOVA) 显示在以下方面具有统计学显着性的组间差异：4 个月和 8 个月随访时的 TOPS 疼痛症状、TOPS 总体疼痛体验、SF-36 身体综合能力和 CSQ 控制疼痛的能力。 目前的 R01 申请是针对 150 名慢性肌肉骨骼疼痛患者进行的 TIVR 随机对照试验 (RCT)。我们提出了一项三臂研究。和以前一样，所有受试者都将接受为期 11 周的标准 CST，以提高疼痛应对技能。同意的受试者将被随机分配至三种研究条件之一：1) 无 TIVR 对照条件（标准治疗）； 2) 注意力控制条件，四个月的每日自我监测问卷调查，每月反馈最少；或 3) 完整 TIVR 条件，四个月的完整 TIVR 通话（所有四个组成部分）。研究目标是：1）尝试在全面的随机对照试验中复制 TIVR 两项试点研究的结果； 2) 确定与注意力控制条件相关的完整 TIVR 的功效。