Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain Following Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 8
- 主要终点
- average pain intensity in the past week
研究概览
简要总结
This study seeks to compare two different behavioral treatments for pain in Veterans with a history of TBI. Both treatments involve educating the Veteran about pain, discussing the impact of pain, and different ways to manage it in hopes of decreasing pain and its impact on life. These approaches are called "self-management" approaches to pain. Both of these treatments are commonly used in pain clinics to treat pain in persons with back pain, headaches, and other types of chronic pain. The investigators will be delivering both treatments over the telephone to make the treatments accessible to Veterans wherever they live.
详细描述
People with a history of traumatic brain injury (TBI) often have pain, such as headaches or neck pain as well as pain from other injuries. Effective treatments that teach people how to manage pain have been used to treat chronic pain in the general population. However, it is often hard for people to access these treatments, as since they are usually only offered in person. The investigators are interested in learning if these treatments can be effectively delivered by telephone, and if the treatments are effective for Veterans with a history of TBI. The purpose of this study is to compare two of these treatments to see if they can be delivered by telephone, and see if they can help reduce pain in Veterans with a history of TBI. Both of these methods are called "self-management" approaches to pain management. Both of these treatments are commonly used in pain clinics and have been used to treat pain in persons with TBI. The investigators are interested in comparing these two different approaches to self-management delivered by phone. Additionally, the investigators want to determine if these treatments can help reduce the negative consequences that pain often causes, such as disruption in mood, daily activities, and enjoyment of life.
The sponsor of this study is the Department of Defense. The scientist in charge of this project is at the University of Washington, as are many of the co-investigators and study staff. However, all the people who participate in this study will be Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) Veterans recruited from VA Puget Sound Health Care System (VAPSHCS). Dr. Rhonda Williams is the scientist at the VAPSHCS who will oversee the project activities at this site. The investigators enrolled 231 subjects into this study. The study will be funded through September 29, 2017.
Subjects will be asked to participate in the following:
1)Informed Consent 2)6 Six Assessments (including cognitive testing, interviews administered by phone and in person) 3)Participate in a telephone-based 1:1 treatment intervention for pain. Subjects will be randomly assigned (by chance, like flipping a coin) to one of the two treatment interventions.
4)All of the activities included in the study are considered research and would not normally be part of the treatment subjects receive at the VAPSHCS.
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
- Double (Participant, 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
- •Veteran Status
- •Diagnosis of TBI of any severity verified in VA medical records (e.g., VA TBI Comprehensive Evaluation or other comparable neuropsychological or medical evaluation in the record)
- •Most recent TBI must have occurred after onset of OEF
- •Military Service in OEF, OIF, and/or OND
- •Average pain intensity in the past month of 4 or above on 0-10 numeric rating scale (moderate pain and above)
- •Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months
- •Able to read and speak English
- •Able to communicate over the phone (i.e., must be verbal)
- •Age 18 years or older
排除标准
- •Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD
- •Communication limitations that would prevent ability to participate in the intervention or assessments
- •Cognitive impairment that interferes with ability to engage in the intervention despite modifications specifically for TBI. This will be defined as a score of 5/10 or less indicating moderate or severe cognitive impairment on the Short Portable Mental Status Questionnaire (SPMSQ)
- •Diagnosis of primary psychotic or major thought disorder as listed in participant's medical record or self-reported
研究组 & 干预措施
Self-Management #2
Self-Management #2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). The sessions will cover a variety of topics, including: (1) the definition of chronic pain, (2) the physiological processes underlying chronic pain, (3) common pain-related conditions such as sleep and mood disturbance (including posttraumatic stress disorder, due to its prevalence among Veterans), (4) the potential effects of chronic pain on activity level, (5) communication (including communication with healthcare providers), and (6) the role of social support in managing pain.
干预措施: Self-Management #2 (Behavioral)
Self-Management #1
Self-Management #1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Sessions will include: (1) education about the role of cognitions and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Most sessions will include a brief relaxation exercise introduced over the phone.
干预措施: Self-Management #1 (Behavioral)
结局指标
主要结局
average pain intensity in the past week
时间窗: 10-12 weeks following randomization (post-treatment)
Average pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0 means "no pain" and 10 means "pain as bad as you can imagine", accompanied by the following instructions: "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours".This NRS will be administered by research staff via telephone assessments four times within the week before treatment begins following enrollment into the study and before randomization (pre-treatment), approximately halfway (4 to 6 weeks following randomization) through treatment (mid-treatment), 10-12 weeks following randomization (post-treatment), and 6 months following randomization (6-month). The arithmetic mean of the four ratings at 10-12 weeks following randomization will be used as the primary outcome measure of average pain level.
次要结局
- average pain intensity in the past week(6 months following randomization)
研究者
Jeanne Hoffman
Professor, Rehabilitation Medicine
University of Washington