Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Depressive Symptoms
研究概览
简要总结
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
详细描述
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.
Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.
Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.
Major hypothesis:
Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, potential subjects must have:
- •access to a telephone
- •documented pain for at least the past year
- •a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
- •pain condition must be stable
- •must have no clear indication for specific medical/surgical intervention.
排除标准
- •Patients were excluded who were:
- •acutely psychotic
- •cognitively impaired
- •showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- •currently abusing alcohol or other drugs, including prescribed opioid pain medications
- •patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
结局指标
主要结局
Depressive Symptoms
时间窗: Baseline, 46 weeks
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Pain Intensity
时间窗: Baseline, 46 weeks
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Level of Functioning
时间窗: Baseline, 46 weeks
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Pain Behavior
时间窗: Baseline, 46 weeks
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
次要结局
未报告次要终点