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?

The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).

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.

What safety data exists for CBT and pain education for chronic pain?

The studies reviewed do not explicitly mention safety data for CBT and pain education. However, they suggest that these interventions are generally beneficial, with improvements in pain severity, depression, and disability. No adverse effects are reported, indicating a favorable safety profile. ^{1 2 3 4 5}

Is Education a promising treatment for chronic pain?

Education can help people understand and manage chronic pain better, but it may not be as effective as Cognitive Behavioral Therapy (CBT) in improving pain-related outcomes. ^{1 6 7 8 9}

What data supports the idea that CBT vs. Empowered Relief for Chronic Pain is an effective treatment?

The available research shows that both CBT and Empowered Relief (pain psychoeducation) are effective treatments for chronic pain. One study found that patients who participated in a psychoeducational group program reported less depression, pain severity, and distress, and more control over their lives. They also had fewer healthcare visits and needed less pain medication. Another study compared CBT and Empowered Relief and found that patients with lower education and literacy benefited more from CBT, while less disadvantaged patients benefited from both treatments. This suggests that CBT, especially when adapted for literacy, can be more effective for certain groups. ^{2 5 10 11 12}

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

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2020]

3. United States 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Importance of education level for effectiveness of multimodal pain therapy]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy (CBT) and pain education for people with chronic pain: Tests of treatment mechanisms. [2021]

7. United States 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pain Education in the Management of Patients with Chronic Low Back Pain: A Systematic Review. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Psychological therapies (Internet-delivered) for the management of chronic pain in adults. [2022]