Comparing Single-Session Therapies for Chronic Pain

NCT ID: NCT07008105

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-08-31

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.

Conditions

Chronic Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy

A 90-minute single-session of Cognitive Behavioral Therapy for chronic pain delivered remotely by doctoral students in clinical psychology

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

CBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change.

Pain Reprocessing Therapy

A 90-minute single-session of Pain Reprocessing Therapy delivered remotely by doctoral students in clinical psychology

Group Type: EXPERIMENTAL

Pain Reprocessing Therapy

Intervention Type: BEHAVIORAL

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.

Emotion Awareness and Expression Therapy

A 90-minute single-session of Emotion Awareness and Expression Therapy delivered remotely by doctoral students in clinical psychology

Group Type: EXPERIMENTAL

Emotion Awareness and Expression Therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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/interpersonal problems.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mark A. Lumley

OTHER

Sponsor Role: lead

Responsible Party

Mark A. Lumley

Distinguished Professor of Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Wayne State University

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark A Lumley, PhD

Role: CONTACT

mlumley@wayne.edu

313-577-2247

Marjorie Heule, MS

Role: CONTACT

mheule@wayne.edu

Facility Contacts

John W Burns, PhD

Role: primary

john_burns@rush.edu

312-942-0379

Mark A Lumley, PhD

Role: primary

mlumley@wayne.edu

313-577-2247

Other Identifiers

IRB-24-10-7277

Identifier Type: -

Identifier Source: org_study_id