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The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood. |
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| Control Group | No Intervention | Patients will receive treatment as usual from their care providers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Participants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately. | 5 weeks post-baseline |
| Hospital Anxiety and Depression Scale | This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity. | 5 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty. | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups |
| Pain Catastrophizing Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain Acceptance Questionnaire | This measure assess acceptance of chronic pain. Total scores range from 0-120 with higher scores indicating greater acceptance. There are 2 subscales: Activity Engagement (range= 0-66) and Pain Willingness (range= 0-54). | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39450755 | Derived | Miller-Matero LR, Hecht LM, Gavrilova L, Haage B, Autio K, Tobin ET, Ahmedani BK. Utilizing primary care to engage underserved patients in a psychological intervention for chronic pain. Prim Health Care Res Dev. 2024 Oct 25;25:e54. doi: 10.1017/S1463423624000471. | |
| 35665994 | Derived | Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14. |
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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 |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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|
This measure assesses catastrophizing thoughts about pain. Total scores range from 0-52 with higher scores indicating greater catastrophizing. The three subscales are rumination (range= 0-16), magnification (range= 0-12), and helplessness (range= 0-24). |
| Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups |
| Satisfaction with Life Scale | This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction. | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups |
| Health care utilization | The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions | Measured 6 months before and 6 months after study enrollment |
| Mindful Attention Awareness Scale |
This measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness. |
| Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups |
| Montreal Cognitive Assessment | Brief screen of cognitive functioning; scores range from 0-30 | Administered at baseline |
| Brief Medical Numbers Test | Brief screen of health numeracy; scores range from 0-4 | Administered at baseline |
| Rapid Estimate of Adult Learning in Medicine | Brief screen of health literacy; patients are categorized into a reading level: at least 9th grade, 7th-8th grade, 4th-6th grade, and 3rd grade or less | Administered at baseline |
| 33616190 | Derived | Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444. |