Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Average pain intensity
研究概览
简要总结
Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.
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
- •Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
- •Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
- •Pain is either worse or started since the onset of the disability;
- •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;
- •Read, write and understand English;
- •Must be able to communicate over the phone (i.e., must be verbal);
- •Age 18 years or older.
排除标准
- •Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
- •Current or previous participation in a psychological treatment for pain (obtained via self-report).
- •Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
研究组 & 干预措施
1
Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) 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. Each intervention 1 session will include a brief relaxation exercise practiced over the phone.
干预措施: Telephone-Delivered Intervention 1 (Behavioral)
2
Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain.
干预措施: Telephone-Delivered Intervention 2 (Behavioral)
结局指标
主要结局
Average pain intensity
时间窗: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).
次要结局
- Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)(pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).)
- Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)(pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).)
- Pain Catastrophizing Scale (Sullivan et al., 1995)(pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization))
研究者
Dawn Ehde
Principal Investigator
University of Washington