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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG059297 | U.S. NIH Grant/Contract | View source | |
| K22NS102334 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Catastrophizing Reduction Group | Experimental | This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing. |
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| Pain Education Group | Active Comparator | This group will receive general information about the neurobiology of pain and knee OA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Intervention | Behavioral | This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Scale (PCS) at Day 2 | 13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing ("Thinking back to your experience during the laboratory pain testing"). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome. | Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Terry, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pain Catastrophizing Reduction Group | This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing. Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise. |
| FG001 | Pain Education Group | This group will receive general information about the neurobiology of pain and knee OA. Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pain Catastrophizing Reduction Group | This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing. Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Catastrophizing Scale (PCS) at Day 2 | 13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing ("Thinking back to your experience during the laboratory pain testing"). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Day 2 |
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Adverse event data were collected an average of 2 weeks.
The cognitive-behavioral intervention posed minimal risk to participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Catastrophizing Reduction Group | This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing. Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Terry | University of Florida | 352-273-6441 | elterry@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2022 | Aug 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2020 | Apr 17, 2024 | ICF_001.pdf |
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Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
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| Pain Education | Behavioral | General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. |
|
| BG001 | Pain Education Group | This group will receive general information about the neurobiology of pain and knee OA. Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Pain Education Group | This group will receive general information about the neurobiology of pain and knee OA. Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Pain Education Group | This group will receive general information about the neurobiology of pain and knee OA. Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. | 0 | 5 | 0 | 5 | 0 | 5 |
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