Chronic Low Back PainNCT03167086
Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
A study testing "Empowered Relief" (ER), Cognitive Behavioral Therapy (CBT) and Health Education (HE) in people with Chronic Low Back Pain, run by Stanford University at 1 site in United States.
Trial summary
This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- "Empowered Relief" (ER), Cognitive Behavioral Therapy (CBT) and Health Education (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 18 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Axial low back pain without radicular symptoms
- Pain duration ≥ 6 months (per recent NIH Task Force on Research Standards for Chronic Low Back Pain based on participant self-report
- Average pain intensity ≥4/10 for the past month at screening visit
- English fluency
- Males and females 18-70 years of age
- Pain Catastrophizing Score (PCS) ≥20
Who cannot join
- Gross cognitive impairment
- Active suicidal ideation or severe depression
- Previous attendance in the active treatment groups (any ER classes ever taken or CBT in the past 3 years)
- Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable
- Current substance abuse
- Clear likelihood to disrupt fellow class participants (e.g., personality disorder) at the discretion of the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Systems Neuroscience and Pain Lab
Palo Alto, California, 94304
About this study
Official title: "Empowered Relief" Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.
Read the detailed description
This is a randomized 3-arm study comprised of 2 active psychological treatments (ER \& CBT) and a health education (HE) arm that controls for time and attention. Study goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.
- Conditions
- Chronic Low Back Pain
- Being tested
- "Empowered Relief" (ER), Cognitive Behavioral Therapy (CBT), Health Education (HE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Empowered Relief" (ER)Behavioural
"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention to treat chronic pain.
Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions.
Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device.
Cognitive Behavioral Therapy (CBT)Behavioural
Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time).
Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) [1\& 2], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner [3].
Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk \& Winter [4] for optional reading.
Health Education (HE)Behavioural
Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience.
Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single Session Skills-Based Pain Psychology Class | Experimental | "Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain. Receives: Behavioral: "Empowered Relief" (ER) |
| Cognitive Behavioral Therapy (CBT) | Active comparator | 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Health Education (HE) | Active comparator | The active control treatment arm consists only of Health Education and has no psychological treatment components. It is a 2-hour HE class matched to the single-session psychological experimental arm (ER) on 4 important factors: duration, structure, format and site. Receives: Behavioral: Health Education (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trait Pain Catastrophizing (Trait PC)
Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups
Measured: 3 months Post-Treatment
Secondary outcomes (3)
Trait PC at 6 months Post-treatment
Change in Trait Pain Catastrophizing (Trait PC) from baseline to 6 months post-treatment across all treatment groups
Measured: 6 months Post-Treatment
PROMIS Measures at 3 months Post-treatment
Change in score of PROMIS domains for chronic pain - including pain intensity, physical functioning, and emotional functioning - from baseline to post-treatment 3 months across all three treatment groups
Measured: 3 months Post-Treatment
Actigraphy for function and sleep
Change in activity \& sleep measures from baseline to post-treatment across all treatment groups
Measured: Several time frames from baseline to 3 months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start8 Jun 2017
- Primary completion25 Jun 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Model description
- The design is a randomized 3-arm study comprised of 2 active psychological treatments (ER \& CBT) and a health education (HE) arm that controls for time and attention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
- Investigators
- Beth Darnall, PhD, Principal investigator, Stanford UniversitySean Mackey, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167086
- Sponsor's protocol ID
- R01AT008561
- Status last verified
- Oct 2020
- First submitted
- 22 May 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Therapist Manual. 2012, Seattle, WA: Group Health Research Institute. (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal investigator).
2. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Patient Workbook. 2012, Seattle, WA: Group Health Research Institute (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal Investigator).
3. Ehde, D.M., Dillworth, T. M., & Turner, J.A. , Cognitive-Behavioral Therapy Manual for the Telephone-Delivered Intervention for Pain Study (Unpublished treatment manual). 2012.
4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association.
Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
PubMed 34398206Darnall BD, Ziadni MS, Roy A, Kao MC, Sturgeon JA, Cook KF, Lorig K, Burns JW, Mackey SC. Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 6;19(1):165. doi: 10.1186/s13063-018-2537-3.
PubMed 29510735
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Empowered Relief" Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
- ClinicalTrials.gov ID
- NCT03167086
- Acronym / sponsor ID
- R01AT008561
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 25 May 2017 (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.
This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.
Detailed description
This is a randomized 3-arm study comprised of 2 active psychological treatments (ER \& CBT) and a health education (HE) arm that controls for time and attention. Study goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The design is a randomized 3-arm study comprised of 2 active psychological treatments (ER \& CBT) and a health education (HE) arm that controls for time and attention.
| Arm | Type | Receives |
|---|---|---|
| Single Session Skills-Based Pain Psychology Class | Experimental | Behavioral: "Empowered Relief" (ER)"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention for chronic pain. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). |
| Health Education (HE) | Active comparator | Behavioral: Health Education (HE)The active control treatment arm consists only of Health Education and has no psychological treatment components. It is a 2-hour HE class matched to the single-session psychological experimental arm (ER) on 4 important factors: duration, structure, format and site. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Axial low back pain without radicular symptoms
- Pain duration ≥ 6 months (per recent NIH Task Force on Research Standards for Chronic Low Back Pain based on participant self-report
- Average pain intensity ≥4/10 for the past month at screening visit
- English fluency
- Males and females 18-70 years of age
Key exclusion criteria (6 listed)
- Gross cognitive impairment
- Active suicidal ideation or severe depression
- Previous attendance in the active treatment groups (any ER classes ever taken or CBT in the past 3 years)
- Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable
- Current substance abuse
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 |
|---|---|---|
| "Empowered Relief" (ER)"Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention to treat chronic pain. Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions. Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device. | Behavioural | Single Session Skills-Based Pain Psychology Class |
| Cognitive Behavioral Therapy (CBT)Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time). Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) [1\& 2], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner [3]. Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk \& Winter [4] for optional reading. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Health Education (HE)Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience. Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention. | Behavioural | Health Education (HE) |
Primary outcome
Trait Pain Catastrophizing (Trait PC)
Time frame: 3 months Post-Treatment
Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups
3 secondary outcomes
Trait PC at 6 months Post-treatment
Time frame: 6 months Post-Treatment
PROMIS Measures at 3 months Post-treatment
Time frame: 3 months Post-Treatment
Actigraphy for function and sleep
Time frame: Several time frames from baseline to 3 months Post-Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background1. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Therapist Manual. 2012, Seattle, WA: Group Health Research Institute. (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal investigator).
- Background2. Stoelb, B., Balderson, B., Turner, J.A., Mind-Body Approaches to Pain Management (MAP) Study: CBT Patient Workbook. 2012, Seattle, WA: Group Health Research Institute (Developed with funding from NIH/NCCAM R01 AT006226; Dan Cherkin, PhD, Principal Investigator).
- Background3. Ehde, D.M., Dillworth, T. M., & Turner, J.A. , Cognitive-Behavioral Therapy Manual for the Telephone-Delivered Intervention for Pain Study (Unpublished treatment manual). 2012.
- Background4. Turk, D.C., Winter, F., The Pain Survival Guide: How to reclaim your life. 2005, Washington, D.C.: American Psychological Association.
- Derived from this study: PubMed 34398206Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
- Derived from this study: PubMed 29510735Darnall BD, Ziadni MS, Roy A, Kao MC, Sturgeon JA, Cook KF, Lorig K, Burns JW, Mackey SC. Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 6;19(1):165. doi: 10.1186/s13063-018-2537-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Beth Darnall, PhD principal investigator
Stanford University
Sean Mackey, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Empowered Relief" (ER), Cognitive Behavioral Therapy (CBT) and Health Education (HE) in people with Chronic Low Back Pain, run by Stanford University at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trait Pain Catastrophizing (Trait PC) (time frame: 3 months Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167086, which also lists 6 linked publications.
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 20 Oct 2020.