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The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.
This study will include patients with chronic low back pain. The main question it aims to answer is:
How do rationales influence the effects of open-label placebos?
Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLP + Standard Rationale | Experimental | Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies. |
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| OLP + Mindfulness Rationale | Experimental | Participants in this group will receive an open-label placebo along with information with mindfulness information. |
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| OLP + Control Rationale | Placebo Comparator | Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. |
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| No Treatment + Control Rationale | Sham Comparator | Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label Placebo | Drug | Open-label placebo pill for 21 days at 2 per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity | across 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain interference | Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function. | across 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo use | across 21 days |
Inclusion criteria are:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordination | Contact | 401-606-4766 | HOPE-trial@lifespan.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40653310 | Derived | Druart L, Lay P, Baird GL, Beaudoin FL, Totten J, Sutherland J, Rosen R, Bernstein MH. Dismantling open-label placebos and their rationales: A remote 4-arm randomized controlled trial protocol. Contemp Clin Trials. 2025 Sep;156:108008. doi: 10.1016/j.cct.2025.108008. Epub 2025 Jul 11. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.
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| Standard Rationale | Behavioral | Scientific rationale about the placebo effect |
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| Mindfulness | Behavioral | Mindfulness based rationale |
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| Control Rationale | Behavioral | Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups |
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| Pain catastrophizing | Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing Item scores are summed into a total score (PCS-T) and three subscale scores:
| across 42 days |
| Prescription Medication use (including opioids) | across 42 days |