Chronic Musculoskeletal PainNCT07008105
Comparing Single-Session Therapies for Chronic Pain
A study testing Cognitive Behavioral Therapy, Pain Reprocessing Therapy and Emotion Awareness and Expression Therapy in people with Chronic Musculoskeletal Pain, run by Mark A. Lumley at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Cognitive Behavioral Therapy, Pain Reprocessing Therapy and Emotion Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Past 2 years (treated for or having experienced):
- Complex regional pain syndrome
- Epilepsy/seizure disorder
- Autoimmune disease
- Liver disease
- Cancer
Show all 17Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marjorie Heule, MS contact
United States2 sites, 2 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
John W Burns, PhD, 312-942-0379, john_burns@rush.edu
John W Burns, PhD
- Recruiting
Wayne State University
Detroit, Michigan, 48202
Mark A Lumley, PhD, 313-577-2247, mlumley@wayne.edu
Mark A Lumley, PhD
About this study
Official title: Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy 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.
Read the 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
- Being tested
- Cognitive Behavioral Therapy, Pain Reprocessing Therapy, Emotion Awareness and Expression Therapy
- Keywords
- Chronic pain, behavioral treatment, CBT, EAET, PRT
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
CBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change.
Pain Reprocessing TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | A 90-minute single-session of Cognitive Behavioral Therapy for chronic pain delivered remotely by doctoral students in clinical psychology Receives: 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) - Pain Severity
4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Immediately pre and immediately post-treatment
Secondary outcomes (22)
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)
Measured: Immediately pre and immediately post-treatment
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Patient Health Questionnaire - Depression
8-item measure of depression symptoms in the past week (range 0 to 3; higher scores = more depression symptoms)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Opioid Use
1-item measure on opioid use in past 7 days (range 1 to 7; higher scores = more days)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Employment
3-item measure on current employment (options for current status and qualitative responses)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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)
Measured: 1-week and 1-month follow-up
Post-Treatment Satisfaction Questionnaire
8-item measure on patient post-treatment satisfaction (range 1 to 10; higher scores = more satisfied - also included qualitative responses)
Measured: 1-week and 1-month follow-up
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
Measured: Baseline to 1-week post-treatment and 1-month follow-up
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/no responses and remaining range 0 to 4; higher scores = more treatment)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Inventory of Interpersonal Problems (IIP)
32-item measure of current interpersonal problems (range 0 to 4; higher scores = more interpersonal problems)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
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)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Psychological Flexibility Scale (PSYFlex)
6-item measure of psychological flexibility in the past week (range 0 to 5; higher scores = higher psychological flexibility)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II
9-item measure on substance use in the past week (yes/no responses); higher scores = more use
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Posttraumatic Stress Disorder Checklist (PCL)
20-item measure of PTSD symptoms (range 0 to 4; higher scores = worse PTSD symptoms)
Measured: Baseline to 1-week post-treatment and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark A. Lumley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark A. Lumley, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008105
- Sponsor's protocol ID
- IRB-24-10-7277
- Status last verified
- Jul 2025
- First submitted
- 14 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Single-Session of Cognitive Behavioral Therapy, Pain Reprocessing Therapy, and Emotion Awareness and Expression Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT07008105
- Acronym / sponsor ID
- IRB-24-10-7277
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Chronic pain, behavioral treatment, CBT, EAET, PRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mark A. LumleyUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyA 90-minute single-session of Cognitive Behavioral Therapy for chronic pain delivered remotely by doctoral students in clinical psychology |
| Pain Reprocessing Therapy | Experimental | Behavioral: Pain Reprocessing TherapyA 90-minute single-session of Pain Reprocessing Therapy delivered remotely by doctoral students in clinical psychology |
| Emotion Awareness and Expression Therapy | Experimental | Behavioral: Emotion Awareness and Expression TherapyA 90-minute single-session of Emotion Awareness and Expression Therapy delivered remotely by doctoral students in clinical psychology |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- Past 2 years (treated for or having experienced):
- Complex regional pain syndrome
- Epilepsy/seizure disorder
- Autoimmune disease
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change. | Behavioural | Cognitive Behavioral Therapy |
| Pain Reprocessing TherapyPRT 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. | Behavioural | Pain Reprocessing Therapy |
| Emotion Awareness and Expression TherapyEAET 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. | Behavioural | Emotion Awareness and Expression Therapy |
Primary outcome
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)
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)
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)
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).
22 secondary outcomes
Mood Rating Question
Time frame: Immediately pre and immediately post-treatment
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
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
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
Patient Health Questionnaire - Depression
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
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
Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Posttraumatic Stress Disorder Checklist (PCL) - Short Form
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Pain Stages of Change Questionnaire (PSOCQ): Preparation and action
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Opioid Use
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Employment
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Patient Global Impression of Change
Time frame: 1-week and 1-month follow-up
Post-Treatment Satisfaction Questionnaire
Time frame: 1-week and 1-month follow-up
Levels of Emotional Awareness Scale (LEAS) - Forms A and B
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Other Pain Treatments and Health Care Use
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Inventory of Interpersonal Problems (IIP)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Psychological Flexibility Scale (PSYFlex)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
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
Posttraumatic Stress Disorder Checklist (PCL)
Time frame: Baseline to 1-week post-treatment and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjorie Heule, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, Pain Reprocessing Therapy and Emotion Awareness and Expression Therapy in people with Chronic Musculoskeletal Pain, run by Mark A. Lumley at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark A Lumley, PhD (313-577-2247, mlumley@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) - Pain Severity (time frame: Baseline to 1-week post-treatment and 1-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.