Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Total pain experience and physical and social disability (as measured by the TOPS)
研究概览
简要总结
The purpose of this study is to determine whether a telephone-based self-monitoring and skills review program with personalized therapist feedback following group CST for chronic pain can reduce and prevent relapse of the pain, physical disability, and psychological distress experienced by patients with chronic pain of the muscles and bone.
详细描述
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, therapeutic IVR (TIVR) was developed as a tool for providing maintenance treatment following group cognitive-behavioral coping skills training (CST), a widely-used behavioral treatment for chronic pain. TIVR has four components:
- an automated daily questionnaire for self-monitoring
- a review of coping skills
- guided behavioral rehearsals of CST coping skills
- personalized monthly feedback messages recorded onto TIVR by the therapist
All four components can be accessed remotely by patients via any touch-tone phone. In a small pilot study, people with severe, chronic musculoskeletal pain received 11 weeks of either CST alone or CST with TIVR access and therapist feedback. Those who used TIVR had better pain outcomes than those who did not. This study will compare the effectiveness of TIVR with or without therapist feedback to a control group not using TIVR at all.
To be eligible for this study, participants must have just completed an 11-week course of CST through the University of Vermont College of Medicine's MindBody Medicine Clinic. At study entry, participants will be randomly assigned to one of three groups. Group 1 is a control group that will not receive any intervention through this study. Group 2 participants will receive full access to TIVR and will get a minimal monthly message from their therapist, who will not use the participant's daily questionnaire data. Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participant's daily questionnaire data. Messages for participants will include any trends the therapist has noted in a participant's stress, sleep, mood, pain levels, coping, and activity, as reported through TIVR. All study participants may continue to receive treatment from their regular physician or take part in other pain management techniques during this study, but such treatment will not be provided through this study.
Upon completing the 11 weeks of CST, all participants will be asked to complete a packet of questionnaires about their chronic pain. At the start of this study, participants in Groups 2 and 3 will have a 30-minute training session on how to use and access TIVR. At Months 4, 8, and 12, participants from all three groups will have follow-up interviews and will complete additional questionnaires.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed 11 weeks of CST through the University of Vermont College of Medicine - Health Behavior Research Center prior to study entry
- •At least 6 months of musculoskeletal pain caused by back, neck, or shoulder pain; osteoarthritis; or fibromyalgia
- •Meet study threshold for pain severity with a Typical Pain score of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire (80)
- •Receiving ongoing standard pain management from a physician (typically involving oral analgesic medication and physical therapy, with or without anesthetic or steroid injections)
排除标准
- •Unable to perform usual self care
- •Cancer that causes or influences patient's chronic pain
- •Cancer requiring radiation or chemotherapy or metastatic cancer of any type
- •Reflex sympathetic dystrophy (RSD)
- •Neuropathic pain
- •Awaiting a pain-related surgical procedure
- •Involved in pain-related litigation or awaiting disability determination
- •Behavioral problems or psychotic disorders that may interfere with the study
- •Inability to use telephone-based TIVR due to cognitive or hearing impairment
- •At risk for suicide
研究组 & 干预措施
1
Control - standard care only
2
Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback
干预措施: Chronic pain therapeutic interactive voice response (TIVR) system (Behavioral)
3
Standard care plus 6 months TIVR receiving detailed monthly feedback
干预措施: Chronic pain therapeutic interactive voice response (TIVR) system (Behavioral)
结局指标
主要结局
Total pain experience and physical and social disability (as measured by the TOPS)
时间窗: 12 months
Pain level (as measured by the McGill Pain Questionnaire)
时间窗: 12 months
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)
时间窗: 12 months
次要结局
- Utilization of telephone system components during the study(daily for 6 months)
- Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)(daily for 6 months)
- General measure of depressive symptoms (measured by the Beck Depression Inventory)(12 months)
研究者
Magdalena Naylor, MD, PhD
Magdalena R. Naylor, MD, PhD
University of Vermont