[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07008105":3,"trial-entities:NCT07008105":208,"trial-summary:NCT07008105":213},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":61,"sex":129,"minimum_age":130,"maximum_age":131,"healthy_volunteers":14,"eligibility_criteria":132,"std_ages":163,"locations":166,"central_contacts":201,"overall_officials":205,"references":206,"see_also_links":207},"NCT07008105","IRB-24-10-7277","Comparing Single-Session Therapies for Chronic Pain","Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy for Chronic Pain","RECRUITING","2026-08","2025-07","2025-07-15","Mark A. Lumley","OTHER",false,"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.\n\nThere 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.\n\nThis 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\u002F 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.",[18],"Chronic Musculoskeletal Pain",[20,21,22,23,24],"Chronic pain","behavioral treatment","CBT","EAET","PRT","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},160,"ESTIMATED",[33,38,42],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Cognitive Behavioral Therapy","CBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change.",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Pain Reprocessing Therapy","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.",[39],{"type":34,"name":43,"description":44,"armGroupLabels":45},"Emotion Awareness and Expression Therapy","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\u002Finterpersonal problems.",[43],[47,51,54,58],{"measure":48,"description":49,"timeFrame":50},"Brief Pain Inventory (BPI) - Pain Severity","4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)","Baseline to 1-week post-treatment and 1-month follow-up",{"measure":52,"description":53,"timeFrame":50},"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)",{"measure":55,"description":56,"timeFrame":57},"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)","Immediately pre and immediately post-treatment",{"measure":59,"description":60,"timeFrame":57},"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).",[62,65,68,71,74,77,80,83,86,89,92,95,98,101,105,108,111,114,117,120,123,126],{"measure":63,"description":64,"timeFrame":57},"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)",{"measure":66,"description":67,"timeFrame":50},"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)",{"measure":69,"description":70,"timeFrame":50},"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)",{"measure":72,"description":73,"timeFrame":50},"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)",{"measure":75,"description":76,"timeFrame":50},"Patient Health Questionnaire - Depression","8-item measure of depression symptoms in the past week (range 0 to 3; higher scores = more depression symptoms)",{"measure":78,"description":79,"timeFrame":50},"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)",{"measure":81,"description":82,"timeFrame":50},"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)",{"measure":84,"description":85,"timeFrame":50},"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)",{"measure":87,"description":88,"timeFrame":50},"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)",{"measure":90,"description":91,"timeFrame":50},"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)",{"measure":93,"description":94,"timeFrame":50},"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)",{"measure":96,"description":97,"timeFrame":50},"Opioid Use","1-item measure on opioid use in past 7 days (range 1 to 7; higher scores = more days)",{"measure":99,"description":100,"timeFrame":50},"Employment","3-item measure on current employment (options for current status and qualitative responses)",{"measure":102,"description":103,"timeFrame":104},"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)","1-week and 1-month follow-up",{"measure":106,"description":107,"timeFrame":104},"Post-Treatment Satisfaction Questionnaire","8-item measure on patient post-treatment satisfaction (range 1 to 10; higher scores = more satisfied - also included qualitative responses)",{"measure":109,"description":110,"timeFrame":50},"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",{"measure":112,"description":113,"timeFrame":50},"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\u002Fno responses and remaining range 0 to 4; higher scores = more treatment)",{"measure":115,"description":116,"timeFrame":50},"Inventory of Interpersonal Problems (IIP)","32-item measure of current interpersonal problems (range 0 to 4; higher scores = more interpersonal problems)",{"measure":118,"description":119,"timeFrame":50},"American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011","8-item measure on fibromyalgia symptoms in the past week (items with yes\u002Fno responses, a checklist, and remaining range 0 to 3; higher scores = worse fibromyalgia symptoms)",{"measure":121,"description":122,"timeFrame":50},"Psychological Flexibility Scale (PSYFlex)","6-item measure of psychological flexibility in the past week (range 0 to 5; higher scores = higher psychological flexibility)",{"measure":124,"description":125,"timeFrame":50},"The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II","9-item measure on substance use in the past week (yes\u002Fno responses); higher scores = more use",{"measure":127,"description":128,"timeFrame":50},"Posttraumatic Stress Disorder Checklist (PCL)","20-item measure of PTSD symptoms (range 0 to 4; higher scores = worse PTSD symptoms)","ALL","18 Years",null,{"inclusion":133,"exclusion":144,"raw_text":162},[134,135,136,137,138,139,140,141,142,143],"Pain for at least 3 months and experienced 4 or more days\u002Fweek 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\u002Ftablet 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",[145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Past 2 years (treated for or having experienced):","Complex regional pain syndrome","Epilepsy\u002Fseizure disorder","Autoimmune disease","Liver disease","Cancer","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\u002F litigating for pain-related disability\u002Fworker's compensation (past year).","Major life event\u002Fstressor in past 6 months","Cognitive impairment (screener score \\\u003C=4)","Inclusion Criteria:\n\n* Pain for at least 3 months and experienced 4 or more days\u002Fweek for the past 6 months\n* Pain intensity last week is \\>= 3 (0 to 10 rating scale)\n* Pain interference last week is \\>= 3 (0 to 10 rating scale)\n* At least age 18\n* Lives in United States\n* Fluent in English\n* Has personal computer\u002Ftablet and internet access\n* Able to attend one 90-minute session\n* Willing to be randomized\n* Seeking to improve their pain-related status via a psychological therapy\n\nExclusion Criteria:\n\n* Past 2 years (treated for or having experienced):\n* Complex regional pain syndrome\n* Epilepsy\u002Fseizure disorder\n* Autoimmune disease\n* Liver disease\n* Cancer\n* Heart disease\n* Substance dependence or use disorder\n* Schizophrenia or other psychotic disorder\n* Bipolar disorder\n* Obsessive-compulsive disorder\n* Borderline personality disorder\n* Suicide attempt or suicide intention or impulse\n* Major medical procedure scheduled within next 2 months\n* Applied for\u002F litigating for pain-related disability\u002Fworker's compensation (past year).\n* Major life event\u002Fstressor in past 6 months\n* Cognitive impairment (screener score \\\u003C=4)",[164,165],"ADULT","OLDER_ADULT",[167,184],{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":172,"contacts":173,"geoPoint":181},"Rush University Medical Center","Chicago","Illinois","60612","United States",[174,179],{"name":175,"role":176,"phone":177,"email":178},"John W Burns, PhD","CONTACT","312-942-0379","john_burns@rush.edu",{"name":175,"role":180},"PRINCIPAL_INVESTIGATOR",{"lat":182,"lon":183},41.85003,-87.65005,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":172,"contacts":189,"geoPoint":198},"Wayne State University","Detroit","Michigan","48202",[190,194,195],{"name":191,"role":176,"phone":192,"email":193},"Mark A Lumley, PhD","313-577-2247","mlumley@wayne.edu",{"name":191,"role":180},{"name":196,"role":197},"Marjorie Heule, MS","SUB_INVESTIGATOR",{"lat":199,"lon":200},42.33143,-83.04575,[202,203],{"name":191,"role":176,"phone":192,"email":193},{"name":196,"role":176,"email":204},"mheule@wayne.edu",[],[],[],{"nct_id":4,"conditions":209,"biomarkers":212},[210,211],"Chronic musculoskeletal pain","Chronic Pain",[],{"nct_id":4,"found":214,"summary":215,"prompt_version":224},true,{"design":216,"status":217,"heading":6,"summary":218,"follow_up":219,"word_count":220,"commitments":221,"compensation":222,"drugs_mentioned":223},"This interventional study plans to enroll 160 participants. Participants will be randomly assigned to receive one of the three therapies or a no-treatment control condition.","completed","This study is comparing three different single-session behavioral therapies for chronic musculoskeletal pain: Cognitive Behavioral Therapy (CBT), Pain Reprocessing Therapy (PRT), and Emotion Awareness and Expression Therapy (EAET). Researchers want to see if these therapies can help reduce your pain and how much it interferes with your daily life. You might be able to join if you are at least 18 years old, live in the United States, have had chronic pain for at least three months, and your pain intensity and interference are at a certain level. The study is currently unclear about its recruitment status and plans to enroll 160 participants. Success will be measured by changes in your pain severity and how much pain interferes with your life, as reported by you.","Your pain levels will be checked at baseline, one week after treatment, and one month after treatment.",125,"You would need to attend one 90-minute session. You will also need a personal computer\u002Ftablet and internet access.","Not stated in the trial record.",[35,39,43],"v2"]