Comparing Single-Session Therapies for Chronic Pain

NCT07008105 | Recruiting

• 1 other identifier: IRB-24-10-7277
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Chronic pain; behavioral treatment; CBT; EAET; PRT

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

  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)

  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).

  Immediately pre and immediately post-treatment

Secondary Outcomes (22)

• 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

Other Outcomes (28)

• Pain Catastrophizing Scale (PCS)-short form

  Baseline to 1-week post-treatment and 1-month follow-up

• Pain Self-Efficacy Questionnaire (PSEQ) - Short Form

  Baseline to 1-week post-treatment and 1-month follow-up.

• Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales

  Baseline to 1-week post-treatment and 1-month follow-up

Study Arms (4)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Pain Reprocessing Therapy

EXPERIMENTAL

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

Behavioral: Pain Reprocessing Therapy

Emotion Awareness and Expression Therapy

EXPERIMENTAL

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

Behavioral: Emotion Awareness and Expression Therapy

Treatment As Usual (TAU)

NO INTERVENTION

Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Cognitive Behavioral Therapy

Pain Reprocessing Therapy 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.

Pain Reprocessing Therapy

Emotion Awareness and Expression Therapy 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.

Emotion Awareness and Expression Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mark A. Lumley: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mark A Lumley, PhD

CONTACT

313-577-2247; mlumley@wayne.edu

Marjorie Heule, MS

CONTACT

mheule@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to condition under after baseline assessment. Outcome assessment will be automated (on-line questionnaires), and thus blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 6, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (2)