Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Brief Pain Inventory (BPI) - Pain Severity
研究概览
简要总结
Many people in the US suffer from chronic pain. Often times, individuals who have chronic pain also feel depressed, anxious, or hopeless, which can worsen pain. Psychologists, therefore, have developed several treatments to help people with chronic pain. These psychological treatments differ. The most common treatment is Cognitive Behavioral Therapy (CBT) for chronic pain, which helps patients better manage pain through changing thoughts and behaviors. Two newer, less common psychological therapies are Pain Reprocessing Therapy (PRT) and Emotion Awareness and Expression Therapy (EAET). These therapies emphasize that chronic pain is mainly due to plastic processes of over-sensitization in the brain and nervous system, and that psychotherapies can significantly reduce or eliminate pain. Although similar, PRT and EAET stress different aspects of treatment. PRT emphasizes that one's fear of pain and bodily injury maintains the brain's sense of threat, thereby also maintaining the pain response; EAET emphasizes that one's conditioned psychological state of stress and tension maintains a sense of threat, thereby maintaining the pain response. These three treatments have yet to be compared; it is unclear which psychological processes are most important to treating chronic pain.
There is growing interest in single-session psychotherapy interventions. Studies have shown that just a single session of CBT or EAET can help individuals reduce their pain. PRT has yet to be condensed to a single-session intervention.
This study will compare a single session of CBT, PRT, and EAET with a no-treatment control group to test whether 1) one treatment outperforms the others, and 2) different mechanisms/ approaches matter to chronic pain treatment.
详细描述
Psychological therapies have been found to improve pain and functioning among individuals with chronic pain. Even a single-session of some of these therapies have been found to reduce pain. There are several competing psychological models and therapies for chronic pain that have yet to be compared in a single-session format: Cognitive Behavioral Therapy (CBT), Pain Reprocessing Therapy (PRT), and Emotion Awareness and Expression therapy (EAET). CBT is the most common behavioral intervention for individuals with chronic pain. CBT assists individuals in modulating thoughts and behaviors in order to better manage their pain. However, two newer behavioral treatments for chronic pain, PRT and EAET, postulate that chronic pain can be eliminated, rather than just managed. Both PRT and EAET emphasize that fear underpins pain generation in the nervous system. PRT suggests that fear of injury or further pain maintains chronic pain. EAET suggests that fear of emotional experiences and life stressors maintain chronic pain. These two new therapies, PRT and EAET, have yet to be compared. Individuals with chronic musculoskeletal pain will be randomized to receive either single-session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, Emotion Awareness and Expression Therapy, or a no-treatment control condition. Participants' pain and mood will be assessed at baseline, pre-intervention, post-intervention, and at two follow-up periods: 1 week and 4 weeks. The purpose of the proposed study is twofold: 1) to compare these three competing models of chronic pain treatment in a single-session, and 2) to investigate what potential mediators of change may be underpinning changes in pain for each treatment. The investigators therefore hypothesize that all 3 treatment types will reduce pain severity and improve functioning; the investigators do not have clear evidence to suggest that one therapy may outperform the others. The secondary hypothesis is that treatment-specific mediators will be more salient in each of the given treatments. The investigators hope to learn what kind of model is most effective for individuals with chronic pain, and whether a single-session of a given intervention can enact meaningful change in pain severity and functioning.
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)
盲法说明
Participants will be blinded to condition under after baseline assessment. Outcome assessment will be automated (on-line questionnaires), and thus blinded.
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
- •Pain for at least 3 months and experienced 4 or more days/week for the past 6 months
- •Pain intensity last week is >= 3 (0 to 10 rating scale)
- •Pain interference last week is >= 3 (0 to 10 rating scale)
- •At least age 18
- •Lives in United States
- •Fluent in English
- •Has personal computer/tablet and internet access
- •Able to attend one 90-minute session
- •Willing to be randomized
- •Seeking to improve their pain-related status via a psychological therapy
排除标准
- •Past 2 years (treated for or having experienced):
- •Complex regional pain syndrome
- •Epilepsy/seizure disorder
- •Autoimmune disease
- •Liver disease
- •Heart disease
- •Substance dependence or use disorder
- •Schizophrenia or other psychotic disorder
- •Bipolar disorder
- •Obsessive-compulsive disorder
- •Borderline personality disorder
- •Suicide attempt or suicide intention or impulse
- •Major medical procedure scheduled within next 2 months
- •Applied for/ litigating for pain-related disability/worker's compensation (past year).
- •Major life event/stressor in past 6 months
- •Cognitive impairment (screener score <=4)
研究组 & 干预措施
Cognitive Behavioral Therapy
A 90-minute single-session of Cognitive Behavioral Therapy for chronic pain delivered remotely by doctoral students in clinical psychology
干预措施: Cognitive Behavioral Therapy (Behavioral)
Pain Reprocessing Therapy
A 90-minute single-session of Pain Reprocessing Therapy delivered remotely by doctoral students in clinical psychology
干预措施: Pain Reprocessing Therapy (Behavioral)
Emotion Awareness and Expression Therapy
A 90-minute single-session of Emotion Awareness and Expression Therapy delivered remotely by doctoral students in clinical psychology
干预措施: Emotion Awareness and Expression Therapy (Behavioral)
Treatment As Usual (TAU)
Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.
结局指标
主要结局
Brief Pain Inventory (BPI) - Pain Severity
时间窗: Baseline to 1-week post-treatment and 1-month follow-up
4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
时间窗: Baseline to 1-week post-treatment and 1-month follow-up
8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)
Pain Rating Question
时间窗: Immediately pre and immediately post-treatment
1-item pain rating developed by research team asking "Please rate your pain by circling the one number that tells how much pain you have right now". (0 = No pain, 10 = Pain as bad as you can imagine; higher = more pain)
Symptom Rating Question
时间窗: Immediately pre and immediately post-treatment
1 -item symptom rating developed by research team asking "Please rate your physical symptoms by circling the one number that tells how much physical symptoms you have right now". (0 = no symptoms; 10 = symptoms as bad as you can imagine; higher = more symptoms).
次要结局
- Employment(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient Global Impression of Change(1-week and 1-month follow-up)
- Post-Treatment Satisfaction Questionnaire(1-week and 1-month follow-up)
- Levels of Emotional Awareness Scale (LEAS) - Forms A and B(Baseline to 1-week post-treatment and 1-month follow-up)
- Pain Stages of Change Questionnaire (PSOCQ): Preparation and action(Baseline to 1-week post-treatment and 1-month follow-up)
- Other Pain Treatments and Health Care Use(Baseline to 1-week post-treatment and 1-month follow-up)
- Mood Rating Question(Immediately pre and immediately post-treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient Health Questionnaire - Depression(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a(Baseline to 1-week post-treatment and 1-month follow-up)
- Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Posttraumatic Stress Disorder Checklist (PCL) - Short Form(Baseline to 1-week post-treatment and 1-month follow-up)
- Opioid Use(Baseline to 1-week post-treatment and 1-month follow-up)
- Inventory of Interpersonal Problems (IIP)(Baseline to 1-week post-treatment and 1-month follow-up)
- American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011(Baseline to 1-week post-treatment and 1-month follow-up)
- Psychological Flexibility Scale (PSYFlex)(Baseline to 1-week post-treatment and 1-month follow-up)
- The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II(Baseline to 1-week post-treatment and 1-month follow-up)
- Posttraumatic Stress Disorder Checklist (PCL)(Baseline to 1-week post-treatment and 1-month follow-up)
研究者
Mark A. Lumley
Distinguished Professor of Psychology
Wayne State University