Clinical trial NCT07008105: Comparing Single-Session Therapies for Chronic Pain
Official title: Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy for Chronic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic pain
behavioral treatment
CBT
EAET
PRT
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Past 2 years (treated for or having experienced):
* Complex regional pain syndrome
* Epilepsy/seizure 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/ litigating for pain-related disability/worker's compensation (past year).
* Major life event/stressor in past 6 months
* Cognitive impairment (screener score \<=4)

Primary outcomes:
measure: Brief Pain Inventory (BPI) - Pain Severity
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Pain Rating Question
timeFrame: Immediately pre and immediately post-treatment
measure: Symptom Rating Question
timeFrame: Immediately pre and immediately post-treatment
Secondary outcomes:
measure: Mood Rating Question
timeFrame: Immediately pre and immediately post-treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient Health Questionnaire - Depression
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Posttraumatic Stress Disorder Checklist (PCL) - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Pain Stages of Change Questionnaire (PSOCQ): Preparation and action
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Opioid Use
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Employment
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Patient Global Impression of Change
timeFrame: 1-week and 1-month follow-up
measure: Post-Treatment Satisfaction Questionnaire
timeFrame: 1-week and 1-month follow-up
measure: Levels of Emotional Awareness Scale (LEAS) - Forms A and B
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Other Pain Treatments and Health Care Use
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Inventory of Interpersonal Problems (IIP)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Psychological Flexibility Scale (PSYFlex)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Posttraumatic Stress Disorder Checklist (PCL)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
Other outcomes:
measure: Pain Catastrophizing Scale (PCS)-short form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Pain Self-Efficacy Questionnaire (PSEQ) - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up.
measure: Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Behavioral Activation for Depression (BADS) - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Self-Compassion Scale (SCS) - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Chronic Pain Acceptance Questionnaire (CPAQ
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Chronic Pain Values Inventory (CPVI)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Emotional Approach Coping Scale (EAC) - Short Form
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Emotional Breakthrough Inventory (EBI)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Psychological Insight Questionnaire (PIQ)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Brain and Psychological Attributions for Pain
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Pain Anxiety Symptom Scale (PASS)
timeFrame: Baseline to 1-week post-treatment and 1-month follow-up
measure: Adverse Events
timeFrame: Post-treatment and at 1-week and 1-month follow-up
measure: Working Alliance Inventory (WAI) - Patient
timeFrame: Immediately post-treatment
measure: Working Alliance Inventory (WAI) - Therapist - Short Form
timeFrame: Immediately post-treatment
measure: Therapist Checklist of Patient Engagement and Homework
timeFrame: Immediately post-treatment
measure: Treatment Expectancy and Credibility Questionnaire
timeFrame: Immediately post-treatment
measure: Evaluation of Therapy Session Rating
timeFrame: Immediately post-treatment
measure: Manipulation Check
timeFrame: Immediately post-treatment
measure: Demographic / medical history
timeFrame: Baseline
measure: Chronic Overlapping Pain Conditions
timeFrame: Baseline
measure: Medication
timeFrame: Baseline
measure: Trauma History Questionnaire - Modified
timeFrame: Baseline
measure: Big Five Inventory, 25-item version
timeFrame: Baseline
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Baseline
measure: Pain DETECT
timeFrame: Baseline
measure: General Pain Treatment Expectancies
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: