CBT vs. Empowered Relief for Chronic Pain

(PROGRESS Trial)

Recruiting at 4 trial locations

Overseen By Steve Denton, LCSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairment, Active suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

1650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two approaches for managing chronic pain. One group will participate in an 8-week cognitive behavioral therapy (CBT) program, learning techniques over sixteen hours to better manage pain. The other group will attend a brief, 2-hour session called Empowered Relief, which focuses on pain relief skills. Individuals with chronic pain lasting at least three months and experiencing pain on most days may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that both Cognitive Behavioral Therapy (CBT) and Empowered Relief are well-received by people with chronic pain. CBT has a strong history of helping those with ongoing pain issues, with research showing its success in improving patient outcomes over time. It has been used safely for various chronic pain conditions, including chronic pelvic pain.

Empowered Relief, a one-time pain management class, has been studied and found to be as effective as longer CBT programs for many people. Studies show it is safe and effective, offering a simpler option for pain management without major side effects.

Both treatments focus on education and skill-building to help manage pain, making them safe choices for participants. They teach coping skills instead of using medications, reducing the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two distinct educational approaches—Cognitive Behavioral Therapy (CBT) and Empowered Relief—for managing chronic pain. Unlike standard treatments that rely heavily on medications like NSAIDs, opioids, or antidepressants, these methods focus on empowering patients with knowledge and skills to manage their pain. CBT helps patients change negative thought patterns that can worsen pain, while Empowered Relief offers a one-time, skills-based class designed to provide rapid pain relief. This trial aims to find out which method is more effective, potentially offering a drug-free, accessible way to alleviate chronic pain for diverse groups, including those with lupus, chronic pelvic pain, and young adults.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial compares cognitive behavioral therapy (CBT) with Empowered Relief for managing chronic pain. Research has shown that CBT effectively manages chronic pelvic pain and other persistent pain conditions, significantly reducing pain and improving mental health. Many reviews support its consistent benefits for chronic pain management. Empowered Relief, another treatment option in this trial, is a brief, one-session treatment that has demonstrated similar results to longer CBT sessions. Studies suggest it provides meaningful pain relief and remains as effective as the longer CBT program six months after treatment, offering a promising option for those seeking quicker help. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults of any sex or gender with chronic pain that's been happening on most days for at least 3 months, and they feel pain intensity of at least 3 out of 10. Participants should be able to understand English, give informed consent, and follow the study plan. People with cognitive impairments, active suicidal thoughts, disruptive behavior history or who've had these treatments recently can't join.

Inclusion Criteria

I have been experiencing pain for most days over the last 3 months.

Ability to adhere to and complete study protocols.

My average pain level in the past month has been 3 or more out of 10.

Exclusion Criteria

Inability to provide informed consent.

Receipt of either study treatment in the past 3 months.

Active suicidality at screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 8-week cognitive behavioral therapy or a 1-session pain relief skills intervention for chronic pain

8 weeks

Online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Education

Trial Overview

The PROGRESS Study is testing two ways to help people with chronic pain: an eight-week course using Cognitive Behavioral Therapy (CBT), which involves sixteen hours total treatment time; versus a single session called Empowered Relief lasting two hours that teaches skills to manage pain.

How Is the Trial Designed?

Group I: Young Adult (18-23) Chronic Pain Experimental Treatment 2 Interventions

150 participants ages 18-23 with Chronic Pain

Group II: PRIME Sample Experimental Treatment 2 Interventions

1200 participants with chronic pain

Group III: Lupus Chronic Pain Cohort Experimental Treatment 2 Interventions

150 participants with Lupus and Chronic Pain

Group IV: Chronic Pelvic Pain Experimental Treatment 2 Interventions

150 participants with Chronic Pelvic Pain

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study involving 290 participants with chronic pain, both cognitive behavioral treatment (CBT) and pain education (EDU) led to changes in pain-related cognition, but these changes did not significantly differ between the two treatments.

The findings indicate that cognitive changes can influence treatment outcomes in a reciprocal manner, suggesting that both CBT and EDU can effectively improve pain self-efficacy and reduce catastrophizing, even if they do not employ the same cognitive restructuring techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy (CBT) and pain education for people with chronic pain: Tests of treatment mechanisms. Burns, JW., Van Dyke, BP., Newman, AK., et al.[2021]

A survey of 97 participants who improved after pain science education revealed that understanding pain as not necessarily indicating bodily damage is crucial for recovery.

Participants valued recognizing the multifactorial influences on pain, including thoughts and emotions, and the ability to retrain their pain response, highlighting the need for patient-centered language in pain education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do patients value learning about pain? A mixed-methods survey on the relevance of target concepts after pain science education. Leake, HB., Moseley, GL., Stanton, TR., et al.[2023]

A systematic review of 19 studies on cognitive behavioral therapy (CBT) for chronic pain found that psychological factors like anxiety, depression, and negative thoughts about pain significantly influence treatment outcomes, with medium to large effect sizes.

Sociodemographic factors had only small effects on CBT outcomes and were not consistently replicable, highlighting the need for more research to identify reliable predictors and improve the consistency of study designs in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. Forden, G., Ronaghan, S., Williams, P., et al.[2023]

Guided internet-based cognitive-behavioral therapy (iCBT) has been shown to be effective for chronic pain management, outperforming both passive and active control conditions in improving psychological, physical, and daily life outcomes across 33 studies with 5133 participants.

The treatment was generally safe with high satisfaction rates and minor adverse events, although dropout rates were influenced by factors like time commitment and technical issues, suggesting that optimizing delivery methods could enhance patient retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. Terpstra, JA., van der Vaart, R., van Beugen, S., et al.[2022]

In a study of 413 patients undergoing a multidisciplinary pain treatment program, significant improvements were observed in pain intensity, disability, depression, and physical functioning after 6 months.

The education level of patients was identified as the strongest predictor of treatment outcomes, suggesting that tailored treatment programs based on education could enhance effectiveness in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of education level for effectiveness of multimodal pain therapy]. Haase, I., Kuhnt, O., Klimczyk, K.[2021]

The psychoeducational pain self-management intervention significantly improved pain management knowledge and self-efficacy among 21 cancer patients and 7 family caregivers, indicating its effectiveness in enhancing their ability to manage pain (p = 0.035 for knowledge, p = 0.007 for self-efficacy).

Support from a competent and trustworthy nurse was crucial in facilitating learning experiences, while health decline was identified as a barrier to effective pain self-management, highlighting the need for personalized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring learning processes associated with a cancer pain self-management intervention in patients and family caregivers: A mixed methods study. Valenta, S., Miaskowski, C., Spirig, R., et al.[2021]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

In a study of 241 participants, literacy-adapted cognitive-behavioral therapy (CBT) for chronic pain was found to be more beneficial for patients with lower education and literacy levels compared to pain psychoeducation groups (EDU).

The results indicate that when CBT is adapted to be more accessible, disadvantaged patients can achieve similar benefits as those with higher literacy, highlighting the importance of tailoring treatments to meet diverse patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain. Van Dyke, BP., Newman, AK., Moraís, CA., et al.[2020]

A psychoeducational group program for 88 chronic pain patients led to significant improvements in mental health and pain management, including reduced depression and pain severity after 16 sessions.

At a 1-year follow-up, participants showed continued benefits such as increased return to work, lower healthcare visits, and reduced reliance on pain medication compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy with the chronic pain patient using coping skills development: outcome study. Cole, JD.[2019]

A systematic review of nine studies on educational interventions for chronic pain found that education alone does not significantly reduce pain or disability in adults, with pooled data showing no improvement compared to usual care.

The only positive outcome was observed with pain neurophysiology education (PNE), which showed a decrease in disability and improved knowledge about pain, but the evidence is not strong enough to recommend PNE as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. Geneen, LJ., Martin, DJ., Adams, N., et al.[2022]

Internet-delivered psychological therapies significantly reduced pain and disability in adults with chronic pain, particularly for those with non-headache conditions, showing moderate to small effect sizes post-treatment.

However, there was no clear evidence that these therapies improved depression or anxiety, and the overall efficacy for headache conditions remains uncertain, highlighting the need for further research and exploration of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological therapies (Internet-delivered) for the management of chronic pain in adults. Eccleston, C., Fisher, E., Craig, L., et al.[2022]

Pain education, particularly neurophysiological pain education, can significantly reduce symptoms of chronic low back pain (CLBP) in the medium term, as supported by 6 out of 13 studies reviewed.

Combining pain education with physical therapy is generally more effective than physical therapy alone for reducing disability associated with CLBP, with 7 out of 11 studies showing clear improvements in disability indices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Education in the Management of Patients with Chronic Low Back Pain: A Systematic Review. Ferlito, R., Blatti, C., Lucenti, L., et al.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1521689620300707

Cognitive behavioral therapy for the treatment of chronic ...

Evidence suggests CBT is beneficial in treating chronic pelvic pain (CPP) patients · Treating the underlying etiology of the CPP is beneficial and may have an ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38228093/

Cognitive Behavioral Therapy for Chronic Pelvic Pain - PubMed

Results: While evidence supports CBT for treatment-refractory chronic pain disorders, there is limited understanding of why or how CBT might work, for whom it ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2819961

Emotional Awareness and Expression Therapy vs CBT for ...

Moreover, 63% of EAET participants had clinically significant (at least 30%) posttreatment pain reduction vs only 17% in CBT. Meaning These ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39462817/

Biopsychosocial Approaches for the Management of ...

CBT and ACT-based biopsychosocial approaches were found effective in reducing pain and improving psychometric outcomes for CPP.

5.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000003847

Cognitive Behavioral Therapy for Chronic Pelvic Pain

Empirical support for CBT as a self-management treatment for chronic pain is based on well over 20 systematic reviews. Meta-analyses generally ...

6.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2387-4

Combined Cognitive-Behavioural and Physiotherapeutic ...

Chronic pelvic pain syndrome (CPPS) is a pain condition perceived in the pelvic area for at least 6 months. While evidence of the aetiology and ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK554585/

Chronic Pelvic Pain - StatPearls - NCBI Bookshelf

Some patients with chronic pelvic pain may benefit from cognitive behavioral therapy (CBT) or hormone replacement, whereas others may require ...

8.

va.gov

va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf

Cognitive Behavioral Therapy for Chronic Pain

Program evaluation results indicate that the training in and implementation of these therapies have significantly enhanced therapist skills and Veteran outcomes ...

9.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2783047

Comparison of a Single-Session Pain Management Skills ...

This randomized clinical trial compares a single-session pain management skills class with 8 sessions of cognitive behavioral therapy and 1 ...