CBT vs. Empowered Relief for Chronic Pain
(PROGRESS Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Cognitive impairment, Active suicidality, others
No Placebo Group
Trial Summary
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 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.
12345What 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.
12678Eligibility Criteria
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 am 18 years old or older.
I have been experiencing pain for most days over the last 3 months.
Ability to adhere to and complete study protocols.
+1 more
Exclusion Criteria
Inability to provide informed consent.
Receipt of either study treatment in the past 3 months.
Active suicidality at screening.
+2 more
Trial Timeline
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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Young Adult (18-23) Chronic PainExperimental Treatment2 Interventions
150 participants ages 18-23 with Chronic Pain
Group II: PRIME SampleExperimental Treatment2 Interventions
1200 participants with chronic pain
Group III: Lupus Chronic Pain CohortExperimental Treatment2 Interventions
150 participants with Lupus and Chronic Pain
Group IV: Chronic Pelvic PainExperimental Treatment2 Interventions
150 participants with Chronic Pelvic Pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
HumanaLouisville, KY
Intermountain HealthcareSalt Lake City, UT
Phoenix VA Health Care SystemPhoenix, AZ
Lehigh Valley Health NetworkAllentown, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Psychotherapy with the chronic pain patient using coping skills development: outcome study. [2019]This study provided outcome data measuring variables of a psychoeducational group approach to self-management of 88 chronic pain patients and 25 controls. Most of the injuries were back injuries and work related. At the completion of the 16 group sessions, patients reported decreased depression, pain severity, interference, and affective distress and increased life control and general activity. At 1-year follow-up, there was continued increased return to work, lowered workers' compensation, fewer health care visits, and less prescribed pain medication than demographically similar controls. Results suggest that a group psychoeducational program involving learning of general coping skills primarily and pain coping skills secondarily produces an effective approach for the management of chronic pain.
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]Differences among patients can moderate the impact of evidence-based treatments (ie, heterogeneity of treatment effects), leading patients to get more or less benefit. The Learning About My Pain study was a randomized, comparative effectiveness trial of a 10-week literacy-adapted group cognitive-behavioral therapy for chronic pain (CBT) versus pain psychoeducation groups (EDU) versus usual medical care. We examined potential sociodemographic and cognitive moderators of treatment effect among participants with post-treatment assessments (N = 241). Analyses were conducted using moderation in the PROCESS macro in SPSS and significant interactions were explored further. Education and primary literacy moderated the difference between CBT and EDU on pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference. Analyses revealed few significant moderation effects relative to usual medical care. No moderators were identified for depression. Neither sex nor minority status moderated any differences between groups. Patients with lower education, literacy, and working memory gained more benefit from CBT than EDU. When provided sufficient guidance and structure in a way that is meaningfully adapted, highly disadvantaged patients achieved as much benefit as less disadvantaged patients, suggesting that the literacy-adapted CBT more successfully met the needs of this population. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01967342 PERSPECTIVE: This article presents findings related to heterogeneity of treatment effects for simplified group psychosocial treatments for chronic pain. The results suggest that educationally, cognitively, or literacy disadvantaged patients benefit most from the more structured approach of literacy-adapted CBT rather than EDU, whereas less disadvantaged patients benefit from either treatment.
What do patients value learning about pain? A mixed-methods survey on the relevance of target concepts after pain science education. [2023]Pain education is a popular treatment approach for persistent pain that involves learning a variety of concepts about pain (ie, target concepts), which is thought to be an important part of recovery. Yet, little is known about what patients value learning about pain. A mixed-methods survey was conducted to identify pain concepts that were valued by people with persistent pain who improved after a pain science education intervention. An online survey was distributed to 123 people who were treated for persistent pain with a pain science education approach; responses of participants who self-identified as "improved" were analysed. Open-ended survey questions were analysed using reflexive thematic analysis and close-ended questions were analysed for frequency of responses. Each question-type was analysed separately, before integration for complementarity. We analysed the data of 97 participants. We constructed 3 themes from the open-ended questions. Pain does not mean my body is damaged (theme 1) captured the importance of abandoning preexisting ideas that pain indicated damage. Thoughts, emotions and experiences affect pain (theme 2) captured the value of recognising multifactorial influences on pain. I can retrain my overprotective pain system (theme 3) captured the importance of conceptualising pain as a heightened protective response that could be lessened. Responses from close-ended questions confirmed that the target concepts represented by these themes are among those most valued, although divergence with the qualitative data suggests differences between patient and clinician language. These data offer patient-centred conceptualizations and language that could assist in further refining pain education interventions.
[Importance of education level for effectiveness of multimodal pain therapy]. [2021]The recommended treatment for chronic pain is multidisciplinary with a cognitive approach. The aim of this study was to investigate whether the education level of patients was predictive of main outcome dimensions (pain intensity, disability, depression, physical functioning and return to work).
Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. [2023]The aim of this systematic review was to synthesise the research identifying possible influences on CBT outcomes in chronic pain. Variations in the effectiveness of psychological therapies, such as CBT, in chronic pain have led to research investigating predictors of improved treatment outcomes.
Cognitive behavioral therapy (CBT) and pain education for people with chronic pain: Tests of treatment mechanisms. [2021]The goals of the study were to determine to what degree changes in pain-related cognition during cognitive behavioral treatment (CBT) and pain education (EDU) represented treatment mechanisms and whether these cognitive changes worked to a larger extent to produce favorable outcomes in CBT than in EDU.
Exploring learning processes associated with a cancer pain self-management intervention in patients and family caregivers: A mixed methods study. [2021]Explore learning processes associated with a psychoeducational pain selfmanagement intervention.
Pain Education in the Management of Patients with Chronic Low Back Pain: A Systematic Review. [2022]New prospective of chronic low back pain (CLBP) management based on the biopsychosocial model suggests the use of pain education, or neurophysiological pain education, to modify erroneous conceptions of disease and pain, often influenced by fear, anxiety and negative attitudes. The aim of the study is to highlight the evidence on the outcomes of a pain education-oriented approach for the management of CLBP. The search was conducted on the Pubmed, Scopus, Pedro and Cochrane Library databases, leading to 2673 results until September 2021. In total, 13 articles published in the last 10 years were selected as eligible. A total of 6 out of 13 studies support a significant reduction in symptoms in the medium term. Disability is investigated in only 11 of the selected studies, but 7 studies support a clear reduction in the medium-term disability index. It is difficult to assess the effectiveness of the treatments of pain education in patients affected by CLBP, due to the multimodality and heterogeneity of the treatments administered to the experimental group. In general, methods based on pain education or on cognitive-behavioral approaches, in association with physical therapy, appear to be superior to physiotherapeutic interventions alone in the medium term.
Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. [2022]Chronic pain has a large individual and societal burden. Previous reviews have shown that internet-based cognitive-behavioral therapy (iCBT) can support patients' pain coping. However, factors related to participant experience of iCBT and effective and safe iCBT delivery for chronic pain have not recently been summarized.
Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. [2022]Chronic pain can contribute to disability, depression, anxiety, sleep disturbances, poor quality of life and increased health care costs, with close to 20 % of the adult population in Europe reporting chronic pain. To empower the person to self-manage, it is advocated that education and training about the nature of pain and its effects and how to live with pain is provided. The objective of this review is to determine the level of evidence for education to facilitate knowledge about chronic pain, delivered as a stand-alone intervention for adults, to reduce pain and disability.
Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]Over the past three decades, cognitive-behavioral therapy (CBT) has become a first-line psychosocial treatment for individuals with chronic pain. Evidence for efficacy in improving pain and pain-related problems across a wide spectrum of chronic pain syndromes has come from multiple randomized controlled trials. CBT has been tailored to, and found beneficial for, special populations with chronic pain, including children and older adults. Innovations in CBT delivery formats (e.g., Web-based, telephone-delivered) and treatments based on CBT principles that are delivered by health professionals other than psychologists show promise for chronic pain problems. This article reviews (a) the evidence base for CBT as applied to chronic pain, (b) recent innovations in target populations and delivery methods that expand the application of CBT to underserved populations, (c) current limitations and knowledge gaps, and (d) promising directions for improving CBT efficacy and access for people living with chronic pain.
Psychological therapies (Internet-delivered) for the management of chronic pain in adults. [2022]Chronic pain (i.e. pain lasting longer than three months) is common. Psychological therapies (e.g. cognitive behavioural therapy) can help people to cope with pain, depression and disability that can occur with such pain. Treatments currently are delivered via hospital out-patient consultation (face-to-face) or more recently through the Internet. This review looks at the evidence for psychological therapies delivered via the Internet for adults with chronic pain.