Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for the Treatment of Chronic Musculoskeletal Pain in Older Veterans: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mean Pain Severity
研究概览
简要总结
A randomized clinical trial for Veterans age 50 years and older with chronic musculoskeletal pain in which Emotional Awareness and Expression Therapy (EAET) is compared against Cognitive Behavior Therapy (CBT) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.
详细描述
Outpatient Veterans age 50 years and older at the West Los Angeles VA Medical Center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: Emotional Awareness and Expression Therapy (EAET), which helps patients make connections between avoided or conflicted emotions and pain, or Cognitive Behavior Therapy (CBT), which teaches pain coping skills. Each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 Veterans). Patients in both conditions complete post-treatment and 3-month follow-up questionnaires. Outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older;
- •3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches.
排除标准
- •Leg pain greater than back pain (to exclude radiculopathy in isolation);
- •Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints;
- •Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
- •Confirmed hip or knee osteoarthritis without any other pain complaints;
- •Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only;
- •Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
- •Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25);
- •Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework;
- •Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain);
- •Unable to fluently read/converse in English;
- •Planning to move from the area in the next 6 months.
研究组 & 干预措施
Emotional Awareness and Expression Therapy
Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
干预措施: Emotional Awareness and Expression Therapy (Behavioral)
Cognitive Behavior Therapy
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
干预措施: Cognitive Behavior Therapy (Behavioral)
结局指标
主要结局
Mean Pain Severity
时间窗: Change from baseline to 20 weeks
Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10.
Mean Pain Severity
时间窗: Change from baseline to 8 weeks
Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1(Change from baseline to 8 weeks)
- Pain Catastrophizing Scale(Change from baseline to 20 weeks)
- PROMIS-Pain Behavior Short Form 7a v1.1(Change from baseline to 20 weeks)
- PROMIS-Depression Short Form(Change from baseline to 20 weeks)
- PROMIS-Pain Interference Short Form 8a v1.0(Change from baseline to 20 weeks)
- NIH Toolbox-Purpose and Meaning Short Form(Change from baseline to 20 weeks)
- Percent of Group Therapy Sessions Attended(8 weeks)
- Satisfaction with Therapy and Therapist Scale-Revised(8 weeks)
- NIH Toolbox-Positive Affect Short Form(Change from baseline to 20 weeks)
- NIH Toolbox-Life Satisfaction Short Form(Change from baseline to 20 weeks)
- Multidimensional Inventory of Subjective Cognitive Impairment(Change from baseline to 20 weeks)
- PROMIS-Fatigue Short Form(Change from baseline to 20 weeks)
- Emotional Approach Coping Scales(Change from baseline to 20 weeks)
- Survey of Pain Attitudes(Change from baseline to 20 weeks)
- PTSD Symptom Scale(Change from baseline to 20 weeks)
- PROMIS-Sleep Disturbance Short Form(Change from baseline to 20 weeks)
- PROMIS-Anxiety Short Form(Change from baseline to 20 weeks)
- Ambivalence over Emotional Expression Questionnaire(Change from baseline to 20 weeks)
- PROMIS-Pain Interference Short Form 8a v1.0(Change from baseline to 8 weeks)
- PROMIS-Depression Short Form(Change from baseline to 8 weeks)
- PROMIS-Anxiety Short Form(Change from baseline to 8 weeks)
- PTSD Symptom Scale(Change from baseline to 8 weeks)
- NIH Toolbox-Positive Affect Short Form(Change from baseline to 8 weeks)
- NIH Toolbox-Purpose and Meaning Short Form(Change from baseline to 8 weeks)
- NIH Toolbox-Life Satisfaction Short Form(Change from baseline to 8 weeks)
- PROMIS-Sleep Disturbance Short Form(Change from baseline to 8 weeks)
- PROMIS-Fatigue Short Form(Change from baseline to 8 weeks)
- Multidimensional Inventory of Subjective Cognitive Impairment(Change from baseline to 8 weeks)
- Ambivalence over Emotional Expression Questionnaire(Change from baseline to 8 weeks)
- Emotional Approach Coping Scales(Change from baseline to 8 weeks)
- Pain Catastrophizing Scale(Change from baseline to 8 weeks)
- Survey of Pain Attitudes(Change from baseline to 8 weeks)