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| ID | Type | Description | Link |
|---|---|---|---|
| GRANT14011002 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This research is studying whether a Zoom-based behavioral intervention may have an impact as a treatment for Veterans with Chronic Low Back Pain (CLBP).
The study will examine:
This study will take place remotely and there will be no on-site visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Pain Reprocessing Therapy (BPRT) | Experimental | Participants will have therapy over the internet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Pain Reprocessing Therapy (BPRT) | Behavioral | Participants will have three 90-minute behavioral intervention sessions over a 3-week period, completing 35 days of brief daily assessments, and one additional set of questionnaires. Participants will also complete study questionnaires at 1, 2, 3, and 6 months after attending the 3 behavioral intervention sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35) | The TEI-SF is a validated instrument for behavioral interventions. There are 9 questions that participants answer from 1 (strongly disagree) - 5 (strongly agree) with a range of (9-45) with a higher score indicating greater acceptability. Scores at 27 or above will denote moderate acceptability of the intervention. | Approximately day 35 (post treatment) |
| Feasibility will be accessed by participant adherence | Adherence to the intervention will be determined by at least 80% attendance of intervention sessions, completion of daily assessment, and self-reported adherence to home-base exposure practices, completion of pre/post session and pre/post interventions. | Up to approximately day 35 (post treatment) |
| Feasibility will be accessed by feedback from the Qualitative Interviews | Qualitative Interviews will occur after conclusion of the intervention period to address areas of improvement in future iterations of the intervention. | Approximately day 35 (post treatment) |
| Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity | There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable). | Baseline, up to day 35 post treatment |
| Safety will be assessed by the PROMIS Depression scale | Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of depression. | Baseline, up to day 35 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK) | There are 17 questions that participants will select from a score of 1 (strongly disagree) - 4 (strongly agree). A total score is calculated after reversing items 4, 8, 12 and 16. The scores range between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. | T1 (Day 1) - T6 (Day 60) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sana Skaikh | Contact | 734-615-9651 | BPRTVeterans@med.umich.edu | |
| Meagan McBride | Contact | 734-615-9651 | BPRTVeterans@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Sturgeon, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Safety will be assessed by the PROMIS Anxiety scale | Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of anxiety. | Baseline, up to day 35 post treatment |
| Safety will be assessed by the Patient Global Impression of Change (PGIC) | There is 1 question that participants will select from 1 (very much improved) - 7 (very much worse). | Baseline, up to day 35 post treatment |
| Safety assessed by the number of Adverse events and Serious adverse events T6 (Day 60) - T9 (Day 210) | Adverse events will be classified as serious or non-serious (per protocol). These will be assessed by items such as death, life-threatening event, hospitalization, emergency room visits, persistent or significant disability/incapacity, suicide plans or attempts. | T6 (Day 60) - T9 (Day 210) |
| Change from T1 to T6 (Day 60) pain intensity | There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable). | T1 (Day 1) - T6 (Day 60) |
| Change from T1 to T6 (Day 60) PROMIS Pain Interference | Participants will answer 4 questions 1 (not at all) -5 (very much). There is a range of scores from 4-20 with a higher score indicating higher levels of interference. | T1 (Day1) - T6 (Day 60) |