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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
CBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change.
PRT advocates a pain treatment model in which pain can be substantially reduced by helping people learn that their pain is brain-based and can be substantially reduced or eliminated by decreasing fear of pain and bodily injury and providing education on the neuroscience of pain.
EAET advocates a pain treatment model in which pain can be substantially reduced by helping people learn that their pain is brain-based and can be substantially reduced or eliminated by decreasing fear of pain and of various emotional/interpersonal problems.
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGWayne State University
Detroit, Michigan, United States
RECRUITINGBrief Pain Inventory (BPI) - Pain Severity
4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Pain Rating Question
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)
Time frame: Immediately pre and immediately post-treatment
Symptom Rating Question
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).
Time frame: Immediately pre and immediately post-treatment
Mood Rating Question
7-item measure to assess current mood developed by research team asking "For each of the items below, use the 1 to 7 scale and circle a number that indicates how you feel right now". Current mood symptoms assess are: calm, sad, proud, afraid, alert, happy, angry, guilty, nervous on a seven-point scale (1 = not at all, 7 = a great deal; higher = more of that mood)
Time frame: Immediately pre and immediately post-treatment
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a
4-item measure of current physical function (range 1 to 5; higher scores = poorer physical function)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form
4-item measure of anxiety symptoms in the past week (range 1 to 5; higher scores = more anxiety symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form
4-item measure of depression symptoms in the past week (range 1 to 5; higher scores = more depression symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient Health Questionnaire - Depression
8-item measure of depression symptoms in the past week (range 0 to 3; higher scores = more depression symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form
4-item measure of fatigue in the past week (range 1 to 5; higher scores = more fatigue)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form
4-item measure of sleep disturbance in the past week (range 1 to 5; higher scores = more sleep disturbance)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a
5-item measure of anger in the past week (range 1 to 5; higher scores = more anger)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form
5-item measure of positive affect in the past week (range 1 to 5; higher scores = more positive affectivity)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Posttraumatic Stress Disorder Checklist (PCL) - Short Form
5-item measure of trauma symptoms in the past week (range 1 to 4; higher scores = worse PTSD symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Pain Stages of Change Questionnaire (PSOCQ): Preparation and action
13-item measure on current readiness to adopt self-management for pain, Preparation and Action items only (range 1 to 5; higher scores = more ready to change)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Opioid Use
1-item measure on opioid use in past 7 days (range 1 to 7; higher scores = more days)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Employment
3-item measure on current employment (options for current status and qualitative responses)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient Global Impression of Change
1-item measure of overall health change since the start of the study (range 1 to 7; higher scores = more health improvement)
Time frame: 1-week and 1-month follow-up
Post-Treatment Satisfaction Questionnaire
8-item measure on patient post-treatment satisfaction (range 1 to 10; higher scores = more satisfied - also included qualitative responses)
Time frame: 1-week and 1-month follow-up
Levels of Emotional Awareness Scale (LEAS) - Forms A and B
10-item measure of current emotional awareness (includes qualitative responses); responses coded for levels of emotional awareness; higher = greater awareness; Form A baseline and Form B at post-treatment
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Other Pain Treatments and Health Care Use
2-item measure of health care currently, the past 6 months, and the past 4 weeks (2 items with yes/no responses and remaining range 0 to 4; higher scores = more treatment)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Inventory of Interpersonal Problems (IIP)
32-item measure of current interpersonal problems (range 0 to 4; higher scores = more interpersonal problems)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
8-item measure on fibromyalgia symptoms in the past week (items with yes/no responses, a checklist, and remaining range 0 to 3; higher scores = worse fibromyalgia symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Psychological Flexibility Scale (PSYFlex)
6-item measure of psychological flexibility in the past week (range 0 to 5; higher scores = higher psychological flexibility)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II
9-item measure on substance use in the past week (yes/no responses); higher scores = more use
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Posttraumatic Stress Disorder Checklist (PCL)
20-item measure of PTSD symptoms (range 0 to 4; higher scores = worse PTSD symptoms)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
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