Strategies to Assist With Management of Pain
STAMP
A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain
4 other identifiers
interventional
770
1 country
4
Brief Summary
Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring non-judgmental and accepting attention to present-moment experiences such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping improve health and well-being, and reduce reliance on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early research, including a pilot study by the Principal Investigator, evidence on MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, the Investigators have designed a study to address this gap and propose a clinical trial that will compare the effectiveness of MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is hypothesized that MM training will lead to a larger reduction in pain intensity, increase in physical function, improvement in quality of life, and decrease in daily opioid dose, as compared to CBT training, with benefits of MM especially notable in adults with worse mood, anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, 766 adults with opioid-treated CLBP will be randomly assigned into one of two 8-week treatment groups: MM (383 participants) that will receive the MM training or CBT (383 participants) that will receive the CBT training. Due to the COVID-19 pandemic-related restrictions, the study protocol was modified in October 2020 so that the study can be completed virtually. The effectiveness of MM versus CBT will be assessed over a 12-month period with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, including patients with opioid-treated CLBP, their families and clinicians.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
June 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
April 1, 2024
5.5 years
April 11, 2017
October 9, 2023
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Composite Pain Severity
Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)
6 months post-entry
Composite Pain Severity
Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)
12 months post-entry
Physical Function
10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)
6 months post-entry
Physical Function
10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)
12 months post-entry
Average Pain Severity
1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)
6 months post-entry
Average Pain Severity
1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)
12 months post-entry
Secondary Outcomes (6)
Health-Related Quality of Life (Physical Health)
6 months post-entry
Health-Related Quality of Life (Physical Health)
12 months post-entry
Health-Related Quality of Life (Mental Health)
6 months post-entry
Health-Related Quality of Life (Mental Health)
12 months post-entry
Average Daily Opioid Dose
6 months post-entry
- +1 more secondary outcomes
Study Arms (2)
Mindfulness Based Therapy
EXPERIMENTALMindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain.
Cognitive Behavioral Therapy
ACTIVE COMPARATORCognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain.
Interventions
The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Pennsylvania State University
Hershey, Pennsylvania, 16802, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53715, United States
Related Publications (2)
Zgierska AE, Edwards RR, Barrett B, Burzinski CA, Jamison RN, Nakamura Y, Henningfield MF, Tuan WJ, Shen C, Sehgal N, Lennon RP, Dong H, Chinchilli VM, Liu Y, Turnquist A, Schiefelbein AR, Jacobs EA, Veasley C, Cowan P, Garland EL. Mindfulness vs Cognitive Behavioral Therapy for Chronic Low Back Pain Treated With Opioids: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253204. doi: 10.1001/jamanetworkopen.2025.3204.
PMID: 40193079DERIVEDZgierska AE, Burzinski CA, Garland EL, Lennon RP, Jamison R, Nakamura Y, Barrett B, Sehgal N, Mirgain SA, Singles JM, Cowan P, Woods D, Edwards RR. Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial. Contemp Clin Trials. 2021 Nov;110:106548. doi: 10.1016/j.cct.2021.106548. Epub 2021 Sep 1.
PMID: 34478870DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aleksandra E. Zgierska, MD, PhD
- Organization
- Pennsylvania State University
Study Officials
- PRINCIPAL INVESTIGATOR
Aleksandra E Zgierska, MD PhD
Penn State University
- PRINCIPAL INVESTIGATOR
Bruce P Barrett, MD PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Although participants, therapists and outcome assessors cannot be blinded to the study intervention, investigators and analysts will be blinded to the group status until the first stages of analysis and reporting are completed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2017
First Posted
April 14, 2017
Study Start
June 30, 2017
Primary Completion
January 15, 2023
Study Completion
January 15, 2023
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
Data dictionaries, programming codes, qualitative codebooks, and other study materials will be provided to the funding agency, Patient-Centered Research Outcomes Institute (PCORI) after the study completion in order to promote replication of the research process. A final, clean dataset will be available for data sharing after the project and analysis completion. PCORI may share these materials and data upon request, after consultation with the PI.