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NCT Number: NCT07008105

Comparing Single-Session Therapies for Chronic Pain

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.

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Key information

Conditions

Chronic Musculoskeletal Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Brief Pain Inventory (BPI) - Pain Severity

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)

  2. Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)

  3. Pain Rating Question

    Time frame: Immediately pre and immediately post-treatment

    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)

  4. Symptom Rating Question

    Time frame: Immediately pre and immediately post-treatment

    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).

Secondary outcomes

  1. Mood Rating Question

    Time frame: Immediately pre and immediately post-treatment

    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)

  2. Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of current physical function (range 1 to 5; higher scores = poorer physical function)

  3. Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of anxiety symptoms in the past week (range 1 to 5; higher scores = more anxiety symptoms)

  4. Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of depression symptoms in the past week (range 1 to 5; higher scores = more depression symptoms)

  5. Patient Health Questionnaire - Depression

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    8-item measure of depression symptoms in the past week (range 0 to 3; higher scores = more depression symptoms)

  6. Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of fatigue in the past week (range 1 to 5; higher scores = more fatigue)

  7. Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    4-item measure of sleep disturbance in the past week (range 1 to 5; higher scores = more sleep disturbance)

  8. Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    5-item measure of anger in the past week (range 1 to 5; higher scores = more anger)

  9. Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    5-item measure of positive affect in the past week (range 1 to 5; higher scores = more positive affectivity)

  10. Posttraumatic Stress Disorder Checklist (PCL) - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    5-item measure of trauma symptoms in the past week (range 1 to 4; higher scores = worse PTSD symptoms)

  11. Pain Stages of Change Questionnaire (PSOCQ): Preparation and action

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    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)

  12. Opioid Use

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    1-item measure on opioid use in past 7 days (range 1 to 7; higher scores = more days)

  13. Employment

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    3-item measure on current employment (options for current status and qualitative responses)

  14. Patient Global Impression of Change

    Time frame: 1-week and 1-month follow-up

    1-item measure of overall health change since the start of the study (range 1 to 7; higher scores = more health improvement)

  15. Post-Treatment Satisfaction Questionnaire

    Time frame: 1-week and 1-month follow-up

    8-item measure on patient post-treatment satisfaction (range 1 to 10; higher scores = more satisfied - also included qualitative responses)

  16. Levels of Emotional Awareness Scale (LEAS) - Forms A and B

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    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

  17. Other Pain Treatments and Health Care Use

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    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)

  18. Inventory of Interpersonal Problems (IIP)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    32-item measure of current interpersonal problems (range 0 to 4; higher scores = more interpersonal problems)

  19. American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    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)

  20. Psychological Flexibility Scale (PSYFlex)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    6-item measure of psychological flexibility in the past week (range 0 to 5; higher scores = higher psychological flexibility)

  21. The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    9-item measure on substance use in the past week (yes/no responses); higher scores = more use

  22. Posttraumatic Stress Disorder Checklist (PCL)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    20-item measure of PTSD symptoms (range 0 to 4; higher scores = worse PTSD symptoms)

Other outcomes

  1. Pain Catastrophizing Scale (PCS)-short form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 6-item measure of pain catastrophizing (range 0 to 4; higher scores = higher pain catastrophizing)

  2. Pain Self-Efficacy Questionnaire (PSEQ) - Short Form

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

    Potential Mediator; 4-item measure of current pain self-efficacy (range 0 to 6; higher scores = higher pain self-efficacy)

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

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 4, 2-item measures of current pain attitudes (range 0 to 4; higher scores = more of that construct)

  4. Behavioral Activation for Depression (BADS) - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 9-item measure of behavioral activation for depression in the past week (range 0 to 6; higher scores = higher behavioral activation)

  5. Self-Compassion Scale (SCS) - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 12-item measure of situational self-compassion (range 1 to 5; higher scores = less self-compassion)

  6. Chronic Pain Acceptance Questionnaire (CPAQ

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 8-item measure of current chronic pain acceptance (range 0 to 6; higher scores = more chronic pain acceptance)

  7. Chronic Pain Values Inventory (CPVI)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 6-item measure of current values (checklist responses)

  8. Emotional Approach Coping Scale (EAC) - Short Form

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 4-item measure of emotional approach coping (range 1 to 4; higher scores = higher emotional approach coping)

  9. Emotional Breakthrough Inventory (EBI)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 6-item measure of emotional breakthroughs in the past week (range 0 to 6; higher scores = more emotional breakthroughs)

  10. Psychological Insight Questionnaire (PIQ)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 6-item measure of psychological insight in the past week (range 0 to 5; higher scores = more psychological insight)

  11. Brain and Psychological Attributions for Pain

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 9-item measure of current belief of brain and psychological attributions for pain (range 0 to 4; higher scores = higher belief in brain and psychological attributions for pain)

  12. Pain Anxiety Symptom Scale (PASS)

    Time frame: Baseline to 1-week post-treatment and 1-month follow-up

    Potential Mediator; 4-item measure of current pain anxiety symptoms (range 0 to 5; higher scores = worse pain anxiety symptoms)

  13. Adverse Events

    Time frame: Post-treatment and at 1-week and 1-month follow-up

    Potential Mediator; 2-item measure of adverse events in the past week and past month (checklist responses)

  14. Working Alliance Inventory (WAI) - Patient

    Time frame: Immediately post-treatment

    Potential Mediator; 6-item measure of current working alliance (range 0 to 5; higher scores = better working alliance)

  15. Working Alliance Inventory (WAI) - Therapist - Short Form

    Time frame: Immediately post-treatment

    Potential Mediator; 6-item measure of current working alliance (range 0 to 5; higher scores = better working alliance)

  16. Therapist Checklist of Patient Engagement and Homework

    Time frame: Immediately post-treatment

    Potential Mediator; 4-item measure on current patient engagement (range 0 to 8; higher scores = more patient engagement)

  17. Treatment Expectancy and Credibility Questionnaire

    Time frame: Immediately post-treatment

    Potential Mediator; 8-item measure on current treatment expectancy and credibility (range 0 to 10; higher scores = better treatment expectancy)

  18. Evaluation of Therapy Session Rating

    Time frame: Immediately post-treatment

    5-item measure evaluating therapy session and insight (range 1-7; higher scores = higher evaluation)

  19. Manipulation Check

    Time frame: Immediately post-treatment

    9-item measure assessing the degree to which participant's learned intervention-specific material (range 1-7; higher = more information learned)

  20. Demographic / medical history

    Time frame: Baseline

    Potential Moderator: several questions on basic patient background demographics and medical history

  21. Chronic Overlapping Pain Conditions

    Time frame: Baseline

    Potential Moderator: Participants indicate whether they "currently have", "had in the past but not now", or "have never had" a variety of common overlapping pain conditions.

  22. Medication

    Time frame: Baseline

    Potential Moderator: 7-item measure assessing whether patients have taken several different kinds of sleep or pain relief medications within the past 24 hours.

  23. Trauma History Questionnaire - Modified

    Time frame: Baseline

    Potential Moderator: 24-item measure of trauma history, assessing both presence and severity of trauma in childhood and adulthood (range: 0 to 6; higher = more traumatic)

  24. Big Five Inventory, 25-item version

    Time frame: Baseline

    Potential Moderator: 25-items measuring the Big Five personality traits: Neuroticism, Extraversion, Openness, Conscientiousness, Agreeableness (range: 1-5, higher scores = more likely to have a given trait on that subscale)

  25. Multidimensional Scale of Perceived Social Support

    Time frame: Baseline

    Potential Moderator: 12-item measure of perceived social support (range 1 to 7, higher = more support)

  26. Toronto Alexithymia Scale (TAS-20)

    Time frame: Baseline

    Potential Moderator: 20-item measure of alexithymia (range 1 to 5; higher = more alexithymic)

  27. Pain DETECT

    Time frame: Baseline

    Potential Moderator: 7-item screener for neuropathic pain (range: 0 to 5; higher = more likely to have neuropathic pain)

  28. General Pain Treatment Expectancies

    Time frame: Baseline

    Potential Moderator: 3-item measure of expectancy of successful treatment (range 0 to 10, higher = greater expectations)

Study contacts

Contact information is provided by the study sponsor or research team.

Marjorie Heule, MS

CONTACT

[email protected]

Mark A Lumley, PhD

CONTACT

[email protected]

313-577-2247

Sponsors and collaborators

Lead sponsor

Mark A. Lumley

Other

Registry information

Official study title

Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy for Chronic Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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