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临床试验/NCT01055639
NCT01055639已完成2 期

Telehealth Therapy for Chronic Pain

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
126
试验地点
2
主要终点
Brief Pain Inventory-interference Subscale

研究概览

简要总结

The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.

详细描述

Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.

Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.

A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, ACT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of ACT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at the VA San Diego Healthcare System (VASDHS) by the PI, suggests that ACT may be superior to CBT as an adjunctive treatment for chronic pain.

The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, individual psychosocial in-person or telehealth intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on ACT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign pain as a secondary condition. The participants are randomized to between-subjects design where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth sessions are conducted using secure video-conferencing equipment at the most convenient clinic for the participant. Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic 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
Double (Investigator, 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

入选标准

  • Chronic non-terminal pain condition;
  • Pain severity and interference rated > 4/10; and
  • Pain most days (> 3/week) for at least 6 months.

排除标准

  • Current participation in group psychotherapy for pain or any type of individual psychotherapy;
  • Previous treatment with ACT;
  • Active suicide ideation or history of suicide attempt within 5 years;
  • Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
  • The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's Computerized Patient Record System (CPRS) medical record or diagnosed during a structured psychiatric interview:
  • schizophrenia;
  • other psychotic disorder;
  • bipolar disorder;
  • organic mental disorder;
  • borderline or antisocial personality disorder; or
  • alcohol or substance abuse or dependence.

结局指标

主要结局

Brief Pain Inventory-interference Subscale

时间窗: 8 weeks

The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).

次要结局

  • Brief Pain Inventory-severity Subscale(8 weeks)
  • West Haven-Yale Multidimensional Pain Inventory - Activity Subscales(8 weeks)
  • SF-12 MCS(8 weeks)
  • SF-12 PCS(8 weeks)
  • Patient Health Questionnaire-9(8 weeks)
  • Pain Anxiety Symptom Scale - 20(8 weeks)
  • PTSD Checklist(8 weeks)
  • Pittsburgh Sleep Quality Index(8 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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